This document provides an overview of GMPc Vietnam Joint Stock Company, including its business details, services, and accomplished projects. GMPc is a consulting firm that provides services related to investment, construction, and operation of manufacturing plants in compliance with GMP, GLP, GDP, and other quality standards. The company has successfully completed over 25 projects since 2011, ranging from pharmaceutical plants and laboratories to packaging and storage facilities. GMPc's services include feasibility studies, design, project management, training, and assistance with certification. The goal is to help clients develop high-quality, cost-effective facilities that meet all regulatory requirements.
This document provides guidelines on Good Manufacturing Practices (GMP) for pharmaceutical products. It discusses key aspects of a Pharmaceutical Quality System including quality management, GMP, quality control, product quality reviews, and quality risk management. The guidelines state that senior management is responsible for establishing an effective quality system to ensure product quality and compliance. It also outlines good documentation practices, change control, outsourcing, complaints handling, and self-inspections which are important parts of GMP and pharmaceutical quality assurance.
Quality Systems Approach to Pharmaceutical cGMPReddy N
This guidance provides a quality systems model that aligns with CGMP regulations to help manufacturers implement modern quality systems approaches. It describes key quality systems concepts such as quality by design, quality risk management, corrective and preventive action, and change control. The guidance explains how the quality unit's responsibilities correlate with quality assurance and quality control functions. It presents a quality systems model organized into sections for management responsibilities, resources, manufacturing operations, and evaluation activities. The model identifies how each quality systems element aligns with specific CGMP regulations.
Presentation: TGA manufacturing principles update - Adoption of PIC/S Guide t...TGA Australia
TGA is adopting updates to the PIC/S Guide to GMP including PE009-13 and future revisions such as PE009-14. Key points include:
- PE009-13 was adopted on January 1, 2018 with a 12 month transition period for industry to comply.
- Future revisions will address additional chapters and annexes to further clarify requirements.
- TGA plays an active role in updating PIC/S GMP guidance to ensure risks are addressed and GMP keeps pace with innovation.
- Adopting international standards supports TGA's mutual recognition agreements and provides assurance in international markets.
Presentation Updating the Manufacturing Principles TGA Australia
The document discusses updates to the PIC/S Guide to GMP (PE009). It provides an overview of the processes used by the EMA, PIC/S, and TGA to adopt and implement GMP updates. It outlines some of the key changes between PE009-13 and the previous version, and discusses future revisions including changes expected in PE009-14 regarding premises and equipment, production, complaints and recalls. The speaker emphasizes that GMPs are updated regularly to address risks to patient health and ensure international equivalence, and that manufacturers should follow the TGA's transition plan to adopt the latest requirements.
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
Presentation PIC/S Guide to GMP PE009-13 Annex 15TGA Australia
The document summarizes key changes made to Annex 15 of the PIC/S Guide to GMP regarding qualification and validation. It introduces concepts such as critical process parameters and critical quality attributes from ICH Q8 and Q11. It provides more flexibility in qualification approaches and emphasizes the need for risk assessments. It also outlines new guidance for various validation approaches including continuous process verification, ongoing process verification, and transportation validation.
This document discusses documentation requirements for good manufacturing practices (GMP) according to WHO guidelines. It covers labeling requirements for containers, equipment, and premises. It also discusses specifications for starting materials, packaging materials, finished products, and intermediates. Master formulas and batch processing records are described. Standard operating procedures (SOPs) are discussed, including activities that require SOPs. Different types of records are outlined, including where they should be stored.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
This document provides guidelines on Good Manufacturing Practices (GMP) for pharmaceutical products. It discusses key aspects of a Pharmaceutical Quality System including quality management, GMP, quality control, product quality reviews, and quality risk management. The guidelines state that senior management is responsible for establishing an effective quality system to ensure product quality and compliance. It also outlines good documentation practices, change control, outsourcing, complaints handling, and self-inspections which are important parts of GMP and pharmaceutical quality assurance.
Quality Systems Approach to Pharmaceutical cGMPReddy N
This guidance provides a quality systems model that aligns with CGMP regulations to help manufacturers implement modern quality systems approaches. It describes key quality systems concepts such as quality by design, quality risk management, corrective and preventive action, and change control. The guidance explains how the quality unit's responsibilities correlate with quality assurance and quality control functions. It presents a quality systems model organized into sections for management responsibilities, resources, manufacturing operations, and evaluation activities. The model identifies how each quality systems element aligns with specific CGMP regulations.
Presentation: TGA manufacturing principles update - Adoption of PIC/S Guide t...TGA Australia
TGA is adopting updates to the PIC/S Guide to GMP including PE009-13 and future revisions such as PE009-14. Key points include:
- PE009-13 was adopted on January 1, 2018 with a 12 month transition period for industry to comply.
- Future revisions will address additional chapters and annexes to further clarify requirements.
- TGA plays an active role in updating PIC/S GMP guidance to ensure risks are addressed and GMP keeps pace with innovation.
- Adopting international standards supports TGA's mutual recognition agreements and provides assurance in international markets.
Presentation Updating the Manufacturing Principles TGA Australia
The document discusses updates to the PIC/S Guide to GMP (PE009). It provides an overview of the processes used by the EMA, PIC/S, and TGA to adopt and implement GMP updates. It outlines some of the key changes between PE009-13 and the previous version, and discusses future revisions including changes expected in PE009-14 regarding premises and equipment, production, complaints and recalls. The speaker emphasizes that GMPs are updated regularly to address risks to patient health and ensure international equivalence, and that manufacturers should follow the TGA's transition plan to adopt the latest requirements.
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
Presentation PIC/S Guide to GMP PE009-13 Annex 15TGA Australia
The document summarizes key changes made to Annex 15 of the PIC/S Guide to GMP regarding qualification and validation. It introduces concepts such as critical process parameters and critical quality attributes from ICH Q8 and Q11. It provides more flexibility in qualification approaches and emphasizes the need for risk assessments. It also outlines new guidance for various validation approaches including continuous process verification, ongoing process verification, and transportation validation.
This document discusses documentation requirements for good manufacturing practices (GMP) according to WHO guidelines. It covers labeling requirements for containers, equipment, and premises. It also discusses specifications for starting materials, packaging materials, finished products, and intermediates. Master formulas and batch processing records are described. Standard operating procedures (SOPs) are discussed, including activities that require SOPs. Different types of records are outlined, including where they should be stored.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
Good Manufacturing Practices (GMP) provide assurance that medicines are manufactured safely, effectively and with quality. GMP involves implementing quality management systems and following inspection guidelines to ensure compliance with standards during production. Inspections verify that manufacturing matches the authorized dossier and marketing approval. GMP guidelines cover APIs, finished pharmaceuticals, and other areas like personnel, facilities, equipment, materials, documentation, production, and quality control. Senior management plays a key role in continuously improving GMP implementation.
The document provides background on the importance of batch production records (BPRs) in manufacturing drug products. It discusses the regulatory basis for BPRs in the Current Good Manufacturing Practices regulation. BPRs must be reviewed by quality control to ensure compliance with standards before a batch is released. The review process should be standardized through standard operating procedures, checklists, and documentation of any exceptions. The review verifies that critical manufacturing steps and parameters were followed correctly.
GMP aims to ensure quality, safety and efficacy of medicines by requiring manufacturers to follow quality standards and comply with marketing authorizations. Inspections verify compliance and identify any deviations between dossiers and actual practices. Quality assurance, GMP, quality control, and quality risk management are interrelated aspects of quality management that are important for producing pharmaceuticals to the required standards.
Due to the poor quality of products it has become mandatory for exporters to conform to quality standards such as ISO and IEC respectively. Quality control is done by adopting two major processes, they are process quality control and consignment-wise inspection. Bureau of Quality Control plays a critical role in quality control and management.
For more such innovative content on management studies, join WeSchool PGDM-DLP Program: http://bit.ly/ZEcPAc
The document describes a post graduate diploma program in Pharmaceutical Quality Assurance and Quality Control offered by the Institute of Good Manufacturing Practices India (IGMPI). The 12-month program covers topics like quality assurance, quality control, validation, documentation, and case studies. It aims to provide knowledge on quality issues, industry needs, and techniques. Graduates can work as QA/QC managers or officers in pharmaceutical and healthcare industries. IGMPI also offers other programs in areas like GMP, regulatory affairs, and clinical research.
This document discusses quality control and good manufacturing practices. It defines quality control and quality assurance, explaining that quality control focuses on detecting errors while quality assurance aims to prevent failures. The document then covers key aspects of good manufacturing practices, including requirements for facilities, equipment, materials, processes, packaging, labeling, documentation, and personnel. It describes the duties of various quality control roles to ensure products meet defined standards and comply with regulations. The objectives are full compliance with drug rules and GMP standards while introducing new products annually, to be measured by key performance indicators.
The document discusses quality management systems in the pharmaceutical industry. It provides an overview of key aspects of quality management including Quality by Design (QbD), Total Quality Management (TQM), ISO 9000 and ISO 14000 standards. The main points are:
1) Quality management systems (QMS) rely on regulations and guidelines to ensure product and process quality in the pharmaceutical industry.
2) QbD and TQM approaches aim to increase manufacturing efficiency and product quality through systematic process understanding and employee involvement.
3) International standards like ISO 9000 specify quality management principles for meeting customer and regulatory requirements, while ISO 14000 provides an environmental management system framework.
The document discusses the basic principles of equipment as it relates to Good Manufacturing Practices (GMP). It outlines objectives like ensuring equipment is properly located, designed, constructed, adapted and maintained. Specific requirements are covered for pipes, balances, production equipment, quality control instruments, washing/cleaning equipment. Design must minimize risks of error and contamination. Equipment must be calibrated and cleaned on a scheduled basis. Current drawings must be maintained and defects addressed. Questions are provided about inspecting and qualifying various equipment types.
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document provides an overview of a training on good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs). The training will cover quality management, personnel, facilities, equipment, documentation, production, validation, laboratory control, stability testing, contract manufacturing, and agents/brokers. It discusses the introduction and scope of GMP guidelines for APIs. Key points include ensuring APIs meet quality and purity standards, applying GMP from receipt of starting materials through packaging and distribution, and the responsibilities of quality units.
The document discusses calculation of yields, production record review, and change control in the pharmaceutical industry. It provides definitions and requirements for theoretical yield, actual yield, and practical yield calculation. It states that all production records must be reviewed and approved before batch release. Any unexplained discrepancies or failed batches must be investigated. The document also defines minor, major, and critical changes and the proper change control process, including documenting the request, assessing the change, planning implementation, verifying the impact, implementing, and closing out the change.
The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
This document provides an overview of Good Manufacturing Practices (GMPs) and how the InstantGMP software guides users through GMP compliance. It discusses GMP requirements for batch production records, master production records, materials management, and quality systems. The InstantGMP software enforces GMP workflows for purchasing, receiving, inventory management, and production. It also offers consulting services to help customers understand GMPs and transition to electronic systems.
This document outlines the Six System Inspection Model used by the US FDA to inspect pharmaceutical manufacturing establishments. The six systems are: Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory Control System. The model provides a comprehensive and organized framework to evaluate if establishments are complying with cGMP requirements across all key aspects of pharmaceutical production.
The document provides guidance on good manufacturing practices for the production of active pharmaceutical ingredients. It discusses quality management, personnel, facilities, equipment, documentation, materials management, production controls, and other quality assurance aspects of API manufacturing. The objective is to help ensure APIs meet quality and purity standards.
Current good manufacturing practices and current good compounding Areej Abu Hanieh
The document discusses current good manufacturing practices (cGMP) regulations established by the FDA to ensure minimum quality standards for drug products. It covers cGMP requirements for facilities, equipment, components, production processes, packaging, labeling, quality control, audits and more. The regulations aim to help manufacturers produce safe and effective pharmaceuticals for patients.
This document provides an overview and summary of current good manufacturing practices (cGMP) regulations as enforced by the FDA in the US. It discusses the contents and subparts of Part 211, which provides the framework for cGMP. Key points covered include principles of cGMP regarding quality management and personnel qualifications. Building and facility requirements, equipment specifications, production and process controls, packaging and labeling, and quality control laboratory functions are also summarized. The document aims to familiarize the audience with cGMP regulations and quality system requirements for pharmaceutical manufacturing.
GMPc Vietnam JSC provides consulting services for investment, construction, and operation of GMP plants. The document outlines the company's profile and services, which include feasibility studies, technology selection, facility design, project management, GMP documentation and training. It also lists several completed and ongoing projects in pharmaceutical manufacturing and packaging that GMPc has consulted on, demonstrating its experience in these areas.
GMPc Vietnam is a leading GMP consulting firm that has completed over 180 projects, accounting for over 80% of GMP-certified projects in Vietnam between 2011-2021. The firm provides comprehensive consulting services from project feasibility to certification for pharmaceutical, cosmetic, food, and veterinary medicine factories. GMPc aims to simplify processes, optimize costs, and guarantee certification for its customers.
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
Good Manufacturing Practices (GMP) provide assurance that medicines are manufactured safely, effectively and with quality. GMP involves implementing quality management systems and following inspection guidelines to ensure compliance with standards during production. Inspections verify that manufacturing matches the authorized dossier and marketing approval. GMP guidelines cover APIs, finished pharmaceuticals, and other areas like personnel, facilities, equipment, materials, documentation, production, and quality control. Senior management plays a key role in continuously improving GMP implementation.
The document provides background on the importance of batch production records (BPRs) in manufacturing drug products. It discusses the regulatory basis for BPRs in the Current Good Manufacturing Practices regulation. BPRs must be reviewed by quality control to ensure compliance with standards before a batch is released. The review process should be standardized through standard operating procedures, checklists, and documentation of any exceptions. The review verifies that critical manufacturing steps and parameters were followed correctly.
GMP aims to ensure quality, safety and efficacy of medicines by requiring manufacturers to follow quality standards and comply with marketing authorizations. Inspections verify compliance and identify any deviations between dossiers and actual practices. Quality assurance, GMP, quality control, and quality risk management are interrelated aspects of quality management that are important for producing pharmaceuticals to the required standards.
Due to the poor quality of products it has become mandatory for exporters to conform to quality standards such as ISO and IEC respectively. Quality control is done by adopting two major processes, they are process quality control and consignment-wise inspection. Bureau of Quality Control plays a critical role in quality control and management.
For more such innovative content on management studies, join WeSchool PGDM-DLP Program: http://bit.ly/ZEcPAc
The document describes a post graduate diploma program in Pharmaceutical Quality Assurance and Quality Control offered by the Institute of Good Manufacturing Practices India (IGMPI). The 12-month program covers topics like quality assurance, quality control, validation, documentation, and case studies. It aims to provide knowledge on quality issues, industry needs, and techniques. Graduates can work as QA/QC managers or officers in pharmaceutical and healthcare industries. IGMPI also offers other programs in areas like GMP, regulatory affairs, and clinical research.
This document discusses quality control and good manufacturing practices. It defines quality control and quality assurance, explaining that quality control focuses on detecting errors while quality assurance aims to prevent failures. The document then covers key aspects of good manufacturing practices, including requirements for facilities, equipment, materials, processes, packaging, labeling, documentation, and personnel. It describes the duties of various quality control roles to ensure products meet defined standards and comply with regulations. The objectives are full compliance with drug rules and GMP standards while introducing new products annually, to be measured by key performance indicators.
The document discusses quality management systems in the pharmaceutical industry. It provides an overview of key aspects of quality management including Quality by Design (QbD), Total Quality Management (TQM), ISO 9000 and ISO 14000 standards. The main points are:
1) Quality management systems (QMS) rely on regulations and guidelines to ensure product and process quality in the pharmaceutical industry.
2) QbD and TQM approaches aim to increase manufacturing efficiency and product quality through systematic process understanding and employee involvement.
3) International standards like ISO 9000 specify quality management principles for meeting customer and regulatory requirements, while ISO 14000 provides an environmental management system framework.
The document discusses the basic principles of equipment as it relates to Good Manufacturing Practices (GMP). It outlines objectives like ensuring equipment is properly located, designed, constructed, adapted and maintained. Specific requirements are covered for pipes, balances, production equipment, quality control instruments, washing/cleaning equipment. Design must minimize risks of error and contamination. Equipment must be calibrated and cleaned on a scheduled basis. Current drawings must be maintained and defects addressed. Questions are provided about inspecting and qualifying various equipment types.
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document provides an overview of a training on good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs). The training will cover quality management, personnel, facilities, equipment, documentation, production, validation, laboratory control, stability testing, contract manufacturing, and agents/brokers. It discusses the introduction and scope of GMP guidelines for APIs. Key points include ensuring APIs meet quality and purity standards, applying GMP from receipt of starting materials through packaging and distribution, and the responsibilities of quality units.
The document discusses calculation of yields, production record review, and change control in the pharmaceutical industry. It provides definitions and requirements for theoretical yield, actual yield, and practical yield calculation. It states that all production records must be reviewed and approved before batch release. Any unexplained discrepancies or failed batches must be investigated. The document also defines minor, major, and critical changes and the proper change control process, including documenting the request, assessing the change, planning implementation, verifying the impact, implementing, and closing out the change.
The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
This document provides an overview of Good Manufacturing Practices (GMPs) and how the InstantGMP software guides users through GMP compliance. It discusses GMP requirements for batch production records, master production records, materials management, and quality systems. The InstantGMP software enforces GMP workflows for purchasing, receiving, inventory management, and production. It also offers consulting services to help customers understand GMPs and transition to electronic systems.
This document outlines the Six System Inspection Model used by the US FDA to inspect pharmaceutical manufacturing establishments. The six systems are: Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory Control System. The model provides a comprehensive and organized framework to evaluate if establishments are complying with cGMP requirements across all key aspects of pharmaceutical production.
The document provides guidance on good manufacturing practices for the production of active pharmaceutical ingredients. It discusses quality management, personnel, facilities, equipment, documentation, materials management, production controls, and other quality assurance aspects of API manufacturing. The objective is to help ensure APIs meet quality and purity standards.
Current good manufacturing practices and current good compounding Areej Abu Hanieh
The document discusses current good manufacturing practices (cGMP) regulations established by the FDA to ensure minimum quality standards for drug products. It covers cGMP requirements for facilities, equipment, components, production processes, packaging, labeling, quality control, audits and more. The regulations aim to help manufacturers produce safe and effective pharmaceuticals for patients.
This document provides an overview and summary of current good manufacturing practices (cGMP) regulations as enforced by the FDA in the US. It discusses the contents and subparts of Part 211, which provides the framework for cGMP. Key points covered include principles of cGMP regarding quality management and personnel qualifications. Building and facility requirements, equipment specifications, production and process controls, packaging and labeling, and quality control laboratory functions are also summarized. The document aims to familiarize the audience with cGMP regulations and quality system requirements for pharmaceutical manufacturing.
GMPc Vietnam JSC provides consulting services for investment, construction, and operation of GMP plants. The document outlines the company's profile and services, which include feasibility studies, technology selection, facility design, project management, GMP documentation and training. It also lists several completed and ongoing projects in pharmaceutical manufacturing and packaging that GMPc has consulted on, demonstrating its experience in these areas.
GMPc Vietnam is a leading GMP consulting firm that has completed over 180 projects, accounting for over 80% of GMP-certified projects in Vietnam between 2011-2021. The firm provides comprehensive consulting services from project feasibility to certification for pharmaceutical, cosmetic, food, and veterinary medicine factories. GMPc aims to simplify processes, optimize costs, and guarantee certification for its customers.
Engineering Group (Pty) Ltd is a black-owned engineering company offering electrical and civil construction services. It has a vision of collaborating with government and private sector to improve communities. The company provides services such as electrical installation and maintenance, civil works including road construction, and project management. It has expertise in various sectors including industrial, commercial, and residential. The directors have qualifications in electrical engineering, civil engineering, and business with experience in construction, maintenance, and project management.
This document provides an overview of production and operations management. It defines production as the process of transforming inputs into outputs through a set of controlled activities. Operations management is responsible for planning, coordinating, and controlling resources to produce goods and services. The key activities in the production cycle are product design, planning and scheduling, production operations, and cost accounting. The production cycle involves information flowing from one activity to the next. Facility layout planning is important for arranging resources in a way that ensures smooth material flow and maximizes productivity. The main types of layouts discussed are process, product, fixed position, cellular manufacturing, and hybrid layouts.
Mc phillips integrated management system manualAbid Iqbal
This document outlines McPhillips (Wellington) Limited's integrated business management system which complies with ISO 9001, ISO 14001, and OHSAS 18001 standards for quality management, environmental management, and health and safety management. It provides information on the company's operations, management structure, policies, and documentation of its management system. The management system is designed to meet business objectives and regulatory standards through continual improvement of processes.
Mc phillips integrated management system manual (1)Abid Iqbal
This document outlines McPhillips (Wellington) Limited's integrated business management system which complies with ISO 9001, ISO 14001, and OHSAS 18001 standards for quality management, environmental management, and health and safety management. It provides information on the company's operations, management structure, policies, and documentation of its management system. The management system is designed to meet business objectives and regulatory standards through continual improvement of processes.
This resume summarizes Dominic Zhang's 20+ years of experience in quality management roles. He has worked in various industries including home appliances, automotive, lighting, and industrial automation. Dominic has extensive experience implementing quality systems and managing quality teams to ensure products meet customer and regulatory requirements. He is proficient in quality tools and systems including APQP, FMEA, SPC, ISO standards, and Lean Six Sigma. Dominic seeks a quality director or senior quality management position where he can continue leveraging his quality expertise.
Ketul Patel is seeking a position utilizing his 9 years of experience in production management, lean manufacturing, and quality tools. He holds a Bachelor's degree in Mechanical Engineering and has a Green Belt in Lean Six Sigma. His experience includes roles in production operations management, process improvement, and quality assurance at Bosch Rexroth India and Lubi Electricals. Patel is proficient in various manufacturing techniques, quality systems, and computer programs including Solidworks, AutoCAD, SAP, and Microsoft Office.
Company Profile of J J Project ConsultantsJayant Joshi
J J Project Consultants is an engineering firm that provides turnkey project consultancy services for dairy, food processing, cold storage, and biogas plants. They have experience developing projects in India and internationally. Their services include project planning, equipment selection, installation, training, and ongoing support. The company aims to analyze clients' needs and design economically feasible, high-quality plants. It is led by Jayant Joshi, who has 30 years of experience in industries.
Debashis Das is a project management and new product development engineer with over 10 years of experience in industries like automotive filtration and metal injection molding. He has a background in mechanical engineering and is a Six Sigma Black Belt. His responsibilities have included project management, quality improvement initiatives, supplier management, and new product development. Currently he works as a project manager at Mann and Hummel Filter in Bangalore, India, leading cross-functional teams and coordinating projects.
The document discusses ISO 9000 standards for software quality assurance. It provides an overview of ISO 9000 and ISO 9000-3, including their scope and key principles. The certification process for ISO 9000-3 involves developing an organization's SQA system, implementing the system, reviewing documentation for compliance, performing audits, and receiving certification from an external body if requirements are met.
At PM Academy, our experienced consultants can conduct assessments on your company’s project management maturity and offer solutions where there are gaps.
This CV summarizes Kenneth Critcher's experience in project management, customer service, and business leadership roles over 25 years. He has extensive experience managing teams, budgets, sales, and customer relationships in industries including construction, facilities management, and logistics. His most recent role since 2014 has been as Principal at Bohen Ltd, where he oversees financial performance, people management, and business development.
This document provides a summary of Bruce Billington's experience and qualifications. He has over 20 years of experience in manufacturing operations and project management roles. His strengths include lean manufacturing, continuous improvement, quality control, and negotiations. Recent roles include operations supervisor increasing on-time delivery and quality from 0% to 80%, and director of operations responsible for all manufacturing, purchasing, and quality assurance.
This document discusses project scope management based on the PMBOK 6th Edition. It begins with an overview of scope management processes including plan scope management, collect requirements, define scope, create WBS, validate scope, and control scope. It then provides more details on various inputs, tools and techniques, and outputs for the plan scope management and collect requirements processes. The document also discusses the differences between product scope and project scope, as well as considerations for scope management in agile projects.
This document provides a project charter for a project aimed at reducing consumer centric quality faults at British American Tobacco. The project will design and implement an improved operating procedure methodology to address the top quality issues identified from customer surveys and complaints. The project objectives are to develop and test the new methodology within 9 days, implement it across all shifts within 12 days, and reduce damages by 10% in the first year. The project is expected to save on costs from reduced damages and complaints while improving customer satisfaction.
Optymyze offers well-designed sales performance management software and professional services with decades of experience implementing technologies and business processes. It follows an agile methodology for projects, allowing flexibility to adapt to changing priorities. The agile approach provides early delivery of value, rapid implementations to reduce costs, and strong adherence to budgets and schedules. Optymyze professionals help customers streamline sales processes, customize solutions for their industry, and ensure user adoption and productivity.
Murad Khan has over 13 years of experience in project management, business operations, and customer service. He has successfully led projects in retail operations and maintenance for gasoline dispenser companies. Currently he is a senior executive managing operations, projects, and customer support for a Japanese pump manufacturing company in India.
Quy trình kiểm soát thay đổi sau khi cấp Giấy chứng nhận GMP/Giấy chứng nhận đủ điều kiện kinh doanh dược đối với cơ sở sản xuất thuốc, nguyên liệu làm thuốc
Quy trình đánh giá đáp ứng “Thực hành tốt sản xuất thuốc, nguyên liệu làm thuốc” (GMP) đối với cơ sở không thuộc diện cấp chứng nhận đủ điều kiện kinh doanh dược
This document lists 46 consulting projects completed or in progress by GMPc Vietnam Joint Stock Company between May 2011 and January 2024. The projects involve consulting services for clients seeking to establish, expand, or renovate pharmaceutical manufacturing facilities that meet Good Manufacturing Practice (GMP) standards set by the World Health Organization (WHO) and other regulatory bodies. Services provided include facility design, budgeting, training on GMP requirements, and assistance with drafting and finalizing GMP registration dossiers. Clients span the pharmaceutical, biotech, and healthcare industries in Vietnam.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
Mercurius is named after the roman god mercurius, the god of trade and science. The planet mercurius is named after the same god. Mercurius is sometimes called hydrargyrum, means ‘watery silver’. Its shine and colour are very similar to silver, but mercury is a fluid at room temperatures. The name quick silver is a translation of hydrargyrum, where the word quick describes its tendency to scatter away in all directions.
The droplets have a tendency to conglomerate to one big mass, but on being shaken they fall apart into countless little droplets again. It is used to ignite explosives, like mercury fulminate, the explosive character is one of its general themes.
Kosmoderma Academy, a leading institution in the field of dermatology and aesthetics, offers comprehensive courses in cosmetology and trichology. Our specialized courses on PRP (Hair), DR+Growth Factor, GFC, and Qr678 are designed to equip practitioners with advanced skills and knowledge to excel in hair restoration and growth treatments.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
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1. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 1
Head Office : Blue Office- No 4- BT1- Bui Xuan Phai Street, My Dinh 2 Ward, Nam Tu
Liem District, Hanoi City, Vietnam
Tel : 0243.994.5757
Branch Office : Floor 2, 156/1/1, Cong Hoa Street, Ward 12, Tan Binh District, Ho Chi
Minh City, Vietnam
Tel : 08.3881.7383
Hotline : 0982.866.668
Email : contact@gmp.com.vn
Website : www.gmp.com.vn
GMPc VIETNAM
COMPANY PROFILE
Hanoi – 2018
2. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 2
TABLE OF CONTENT
Part 1: Overview
- Business details
- Services
Part 2: Accomplished projects and Staff
- Accomplishments
- Staff
Part 3: Appendices
- Images of significant projects
3. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 3
Part 1
OVERVIEW
4. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 4
I – Business details and Strategy
1. Business details
Name : GMPc VIETNAM JOINT STOCK COMPANY
Abbreviation : GMPc JSC.;
Legal representative : Mrs. Ha Thi Ngoc Tran – Chief Executive Officer
Head Office : Blue Office- No 4- BT1- Bui Xuan Phai Street, My
Dinh 2 Ward, Nam Tu Liem District, Hanoi City,
Vietnam
Telephone : 024.3994.5757
Branch Office : Floor 2, 156/1/1, Cong Hoa Street, Ward 12, Tan
Binh District, Ho Chi Minh City, Vietnam
Telephone : 028.3881.7383
Hotline : 0982.866.668
Email : contact@gmp.com.vn
Website : www.gmp.com.vn
Business Type : Joint-stock
2. Foundation:
- Company established: 25/5/2011
- Business registration certificate: 0105328140 (issued by Office of Business Registration
- Hanoi Department of Planning and Investment at 25/5/2011)
- Charter capital: 5,000,000,000 VND (Five billions VND)
3. Our strategy:
Vision and Mission:
Our mission is to become the national leader in the field of GMP consultancy by inspiring
and utilizing powerful minds to propose professional, practical yet innovative and flexible
solutions to assist client in operating and managing GMP plants in a cost-effective
manner.
Core values
Services
5. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 5
Combining essential needs and functional requirements of clients with profound
knowledge and practical experience in GMP consultancy of our staff, GMPc devise and
propose a variety of comprehensive services which are:
- Greatly simplified: we eliminate superfluous procedures, while ensure all GMP
requirements are completely fulfilled.
- Highly practical and professional: we deliberately assess and compare client’s
demands with GMP guidelines as well as current national regulations to propose
the most appropriate and feasible solutions.
- Reasonably flexible yet creative: we can continuously modify proposed plans to fit
in with client’s actual situation while still strictly fulfill GMP standards as well.
Human resources
In GMPc Vietnam, we honor human minds as our core competency as it is an unlimited
source of creativity and potential which draws a significant distinction between us and
other consultancy firms. Hence, we constantly develop strategic plans to improve staff
performance, including:
- Organizing internal training and experience-sharing sessions.
- Providing external opportunities which put forward cooperation with recognized
experts, authorities, institutes and universities.
- Organizing educational visits to GMP manufacturing plants, allowing staff to get
and broaden practical experience.
Public image
A Responsible – Trustworthy – Innovative consultancy company.
Slogan: GMPc – Get GMP – Get what you want!
GMPc Vietnam Joint-stock Company
6. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 6
II. SERVICES
We provide a wide range of advisory services regarding to investment, construction and
operation of manufacturing plants that are complied with GxPs guidelines, particularly:
1. Conducting feasibility study:
Goals: We explore and evaluate client’s needs and functional requirements to
propose feasibility reports and project cost plans
2. Counselling on technology
Goals: Depending on products characteristics and production target, we assist
clients establish process technology and define equipment technical specifications.
We also provide lists of recommended machinery manufacturers and suppliers (at
least 3 options for each equipment) to clients for full consideration.
3. Designing construction drawings and M&E system
Goals: We completely design architectural and structural drawings and drawings of
HVAC unit, electricity and light, water supply and drainage system, and so on. All
designed drawings are strictly complied with GMP guidelines and greatly fit in with
production processes.
4. Managing and monitoring the project
Goals: In terms of project management, we assist client to oversee and monitor
works progress regarding to construction and installation, quality standards, safety
issues and maintain relationships among contractors and suppliers as well. Our
ultimate mission is to guarantee the project can be completed on time and within
budget.
5. Organizing training session on GxPs guidelines (GMP, GLP, GSP)
Goals: Having a team of experienced experts, we offer the most practical and
professional training sessions on GxPs guidelines which not only involve critical and
fundamental concepts but also contain detail explanation of GMP implementation
in practices.
6. Preparing required documentation to apply for GxP Certifcation (GMP, GLP, GSP)
Goals: We completely prepare essential documents such as site master file, quality
manual, specifications and so on to apply for GxPs Certification. At the same time,
we systematically organize and conduct self-inspection in order to find out
problems and propose feasible corrective measures.
7. Managing manufacturing performance
7. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 7
Goals: GMPc take the responsibilities of a production manager, planning and
organizing production schedules, overseeing manufacturing process and ensuring
quality control standards, health and safety requirements are met.
8. Supervising manufacturing process in outsourcing Manufacturing plant
Goals: GMPc works on behalf of clients to supervise and manage the manufacturing
process in the outsourcing plant, assuring all GMP requirements are met and the
finished products are qualified.
9. Assessing manufacturing plants effectiveness
Goals: Since product quality is a key factor of successful sustainable development
and reputation, we help our clients to thoroughly assess manufacturing plants
effectiveness. Using variety approaches, we comprehensively evaluate the fitness
level of the target plants from different aspects ranging from plant’s structural
design and layout to technical specifications of existing instruments and equipment,
and the implementation status of GMP guidelines in production process. The result
is a detailed analysis report which provides valuable perspectives on the processing
plants, allowing the Investor to select the most suitable one.
10. Optimizing manufacturing formula and process
Goals: We design experiments to optimize products’ manufacturing formula and its
production process, greatly improving product quality and productivity while, at the
same time, universally reducing overall lead time and total costs.
11. Assisting on technology transfer in terms of formula and manufacturing process
Goals: We have established a network of professional relationships with
international manufacturers and experts to help our clients to conduct product
research effectively regarding either manufacturing formula or product packaging
that suitable with Investor’s business goals.
12. Establishing specifications
Goals: Depending on the materials, products and the production lines, we precisely
determine sets of essential requirements and publish these specifications for quality
control.
13. Assisting in Product registration
Goals: We offer consulting service to clients in doing product registration,
particularly from preparing documentation phase to applying dossier to
authorization and acquiring certification step.
8. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 8
14. Setting up laboratories in compliance with GLP
Goals: We assist customers to set up functional laboratories that are strictly
complied with GLP guidelines in terms of staff, equipment and documentation.
15. Assisting in implementation of GSP, GDP, GPP guidelines
Goals: We help clients to set up qualified GSP storages as well as develop effective
approaches to successfully build and implement GSP and GPP guidelines.
16. Counselling on applying WHO - GACP
Goals: We offer complete WHO – GACP consulting services to clients that cultivate,
obtain and manufacture medicinal plant materials for the sustainable production of
herbal products classified as medicines.
17. Organizing training sessions on GMP, GLP, GPs
Goals: Depending on clients’ requirements, we systematically organize training
sessions on GMP, GLP and GPs guidelines, providing guidance for implementation of
GxPs guidelines on manufacturing, testing and quality assurance processes.
.
GMPc Vietnam Joint-Stock Company
9. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 9
Part 2
Accomplished projects
10. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 10
I. Accomplished Projects
Established on 25/05/2011, GMPc has greatly contributed to the accomplishment
of a variety of building projects in all fields such as pharmaceutical manufacturing,
pharmaceutical packaging, veterinary medicines, cosmetics and so on. The following list
describes our works detailly:
List of accomplished projects (from 5/2011 to 5/2018)
No Main tasks Status Client Time
A Pharmaceutical plants (GMP-WHO), GLP laboratories and GSP storages Projects
1.
- Identify and prescribe
construction requirements and
Design M&E system for
Cephalosporin plant complied with
EU-GMP
On going
NATIONAL DAY
PHARMACEUTICAL .JSC
(Ho Chi Minh)
5/2018
2. - Design a site plan of GSP storage On going
ACE PHARMA CO.,LTD
(Ho Chi Minh)
5/2018
3.
- Counsel on the master plans and
Estimate the total investment
- Identify and prescribe
construction requirements and
Design M&E system for herbal
medicines manufacturing plant
complied with WHO-GMP
On going
FUMA PHARMA
CO.,LTD
(Luong Son – Hoa Binh)
4/2018
4.
- Counsel on manufacturing
technology and Design plant layout
- Identify and prescribe
construction requirements and
Design M&E system
On going
SYNTECH
PHARMACEUTICAL .JSC
(Hai Duong)
2/2018
11. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 11
No Main tasks Status Client Time
5.
- Design site plans of GSP storage
- Organizing training sessions on
GSP guidelines and completely
prepare GSP documentation for
auditing
On going
QUANG PHAT ME
CO.LTD
(Ho Chi Minh)
2/2018
6.
- Counselled on technology,
master plan and developing
solutions for plant renovation
- Provided design consulting
service
Completed
FATACO BEN TRE
IMPORT – EXPORT
TRADING AND
SERVICES CO., LTD
VIETNAM
(Ben Tre)
10/2017
7.
- Counselled on technology,
master plans and Estimated the
total investment
- Designed M&E system
- Organized training sessions on
GDP and completely prepared
essential documentation for
GMP auditing
Completed
PHUC HUNG TRADING
CHEMICAL CO., LTD
(Ba Dinh – Ha Noi)
8/2017
8.
- Designed floor plans for tablet
and capsule production lines
complied with WHO-
GMP/GLP/GSP
Completed
LOC PHUC CO., LTD
(Ho Chi Minh)
5/2017
9.
- Designed solutions for office
renovation and GSP warehouses
construction
Completed
CODUPHA CENTRAL
PHARMACEUTICAL
JSC.,
(Da Nang)
3/2017
10.
- Assisted in supervising and
monitoring project of
constructing GSP storage
Completed
CODUPHA CENTRAL
PHARMACEUTICAL
JSC.,
(Ho Chi Minh)
1/2017
12. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 12
No Main tasks Status Client Time
11.
- Designed construction drawings
and Estimated cost plans for GSP
storage building project,
including M&E system and fire
fighting system
Completed
HANOI
PHARMACEUTICAL
AND MEDICAL
EQUIPMENT IMPORT –
EXPORT JSC.,
(Hoan Kiem, Ha Noi)
3/2016
12.
- Designed construction drawings
and M&E system
- Organized training sessions on
WHO-GMP/GLP/GSP
Completed
Di Hao JSC.,
(Long An)
04/2015
13.
- Conducted feasibility study
- Counselled on technology and
Designed construction drawings
and M&E system
- Assisted in project management
- Organized training sessions on
WHO GMP and prepared
essential documentation for
GMP auditing
Completed
HOANG LIEN
MEDICINAL MATERIALS
JSC.,
(Phu Tho)
04/2015
14.
- Counselled on technology
- Organized training sessions on
WHO GMP/GLP/GSP for
manufacturing adjuvant
Completed
MAT&G JSC.,
(Hoa Binh)
11/2014
15.
- Conducted feasibility study
- Provided design consulting
service
- Oversaw and monitored project
progress
- Organized training sessions on
GMP and completely prepared
essential documentation for
Completed
VIET NAM MEDICINAL
MATERIALS JSC.,
(Ninh Hiep- Ha Noi)
10/2014
13. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 13
No Main tasks Status Client Time
GMP auditing
16.
- Provided design consulting
service
- Provided bid consulting service
- Oversaw and monitored project
progress
- Prepared GMP application
dossier
Completed
VCP PHARMACEUTICAL
JSC.,
(Soc Son – Ha Noi)
09/2015
17.
- Designed construction drawings
and M&E system
- Counselled on technology and
equipment
- Oversaw and monitored project
progress (construction and M&E
system)
Completed
CUU LONG
PHARMACEUTICAL
JSC.,
(Binh Thuy – Can Tho)
04/2014
18.
- Designed construction drawings
and M&E system
- Counselled on technology and
equipment
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP auditing
Completed
408 DONG TAM
PHARMACEUTICAL
CENTRE
(Dong Tam – Tien
Giang)
04/2014
19.
- Counselled on process
technology of manufacturing
heat-resistant spores
(pharmaceutical material)
- Designed M&E system
- Monitored equipment
installation progress
- Organized training sessions on
Completed
BIOSPRING HOA
LAC.,JSC
(Ha Noi)
03/2014
14. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 14
No Main tasks Status Client Time
GMP and completely prepared
essential documentation for
GMP auditing
20.
- Designed construction drawings
and M&E system
- Provided bid consulting service
- Oversaw and monitored project
progress (construction and M&E
system)
- Prepared GSP documentation
Completed
HANOI
PHARMACEUTICAL
AND MEDICAL
EQUIPMENT IMPORT –
EXPORT JSC.,
(KCN Tan Binh,
TP.HCM)
09/2013
21.
- Oversaw and monitored project
progress (construction and
equipment installation).
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP auditing
Completed
QUILPEX CO., LTD
(Gia Lam - Ha Noi)
12/2012
22.
- Managed DHG pharmaceutical
plant construction project
Completed
DHG
PHARMACEUTICAL
JSC.,
(Can Tho)
09/2011
23.
- Assisted in completing
conceptualization phase and
designing preliminary design
complied with national
standards
Completed
KAJIMA OVERSEAS ASIA
PTE LTD.,
(Tra Vinh)
07/2015
24.
- Proposed warehouse renovation
designs; Estimated cost plans
and Monitored construction and
installation progress
Completed
NINH HIEP PHARMA
JSC.,
(Gia Lam, Ha Noi)
06/2015
25. - Designed and constructed floor Completed SOIL QUALITY 11/2015
15. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 15
No Main tasks Status Client Time
area used epoxy or PU resin
- Designed cleanroom panel
system (walls, roofs, doors and
so on)
- Designed HVAC unit
- Designed electricity and lighting
system
- Estimated detailed cost plan
CONTROL CENTRE OF
VINH PHUC PROVINCE
(Vinh Yen, Vinh Phuc)
26.
- Counselled on technical
solutions and technology
- Counselled on building solutions
- Evaluated environmental
impacts
- Counselled on plant operation
and management
Completed
PHARMATOPES VIET
NAM .,JSC
(Ba Dinh, Ha Noi)
8/2016
27.
- Determined plant layout
- Created lists of auxiliary facilities
- Established project timeline
- Estimated total investment
- Assisted in preparing
documentation for building
permit, fire safety permit and
carrying out environmental
impact assessment
Completed
DUC THINH DUONG
TRADITIONAL
MEDICINES
(Ngo Quyen, Hai
Phong)
7/2016
28.
- Designed a master plan
- Designed M&E system and
Evaluated total investment
Completed
FITO PHARMA CO.,LTD
(Thuan An, Binh Duong)
5/2016
29.
- Designed a master plan and
determined plant layout
- Proposed solutions for
Completed
CODUPHA CENTRAL
PHARMACEUTICAL
JSC.,
8/2016
16. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 16
No Main tasks Status Client Time
renovating M&E system,
security system and fire safety
system
- Estimated total investment
(District 10, TP.HCM)
B Projects on Cosmetic manufacturing plant (cGMP ASEAN)
30.
- Design and construct cosmetic
manufacturing plant in
compliance with CGMP ASEAN
On going HAPPY SECRET CO., LTD 1/2018
31.
- Provide engineering design
consulting service
- Organize training sessions on
GMP and completely prepared
essential documentation for
cGMP ASEAN auditing
On going
WORLD ESSENCE USA
CO., LTD
(Ho Chi Minh)
11/2017
32.
- Proposed renovation solutions
and designed M&E system for
cosmetic manufacturing plant
in compliance with national
standards
Completed
THOI TRANG NGOC NHI
CO., LTD
(Ho Chi Minh)
10/2017
33.
- Determined plant layout;
Proposed renovation solutions
and designed M&E system for
cosmetic manufacturing plant
in compliance with national
standards
Completed
THAI HUONG
INVESTMENT CO., LTD
(Hoang Mai, Ha Noi)
8/2017
34.
- Supplied and installed air
conditioning system and RO
water system
Completed
CHJAKJ LINH FRESH
LIPSTICK CO., LTD
(Dong Da, Ha Noi)
7/2017
35.
- Organized training sessions and
prepared documentation to
Completed
GREEN ROSE CO.,LTD
(Q. 6, Ho Chi Minh)
6/2017
17. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 17
No Main tasks Status Client Time
acquire Certificate of eligibility
for cosmetic manufacturing
36.
- Determined plant layout and
Counselled on designing master
plans
- Estimated total investment
Completed
BUI MINH DUC
(Dong Da, Ha Noi)
5/2107
37.
- Designed construction drawings
and M&E system
- Oversaw and monitored project
progress (construction and
M&E system)
- Organized training sessions on
GMP and completely prepared
essential documentation for
cGMP ASEAN auditing
Completed
WORLD ESSENCE
CO.,LTD
(Nha Be, Ho Chi Minh)
3/2017
38.
- Provide engineering design
consulting service
- Organized training sessions on
GMP and completely prepared
essential documentation for
cGMP ASEAN auditing
Completed
VINCOS VIET NAM .,
JSC
(Ha Noi)
4/2017
39.
- Proposed renovation solutions
and designed M&E system for
cosmetic manufacturing plant
in compliance with national
standards
Completed
WONMOM TRADING
AND SERVICE CO.,LTD
(Go Vap, Ho Chi Minh)
3/2017
40.
- Proposed renovation solutions
and designed M&E system for
cosmetic manufacturing plant
in compliance with national
standards
Completed
CA CAO NONG LAM
CO., LTD
(Binh Thanh, Ho Chi
Minh)
3/2017
18. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 18
No Main tasks Status Client Time
41.
- Designed a master plan and
determined plant layout
- Estimated total investment
Completed
SOUTHERN BEAUTY
CO., LTD
(Thu Dau Mot, Binh
Duong)
2/2017
42.
- Designed a master plan and
determined plant layout
- Estimated total investment
Completed
TOP QUEEN COLLAGEN
CO.,LTD
(Hai Ba Trung, Ha Noi)
1/2017
43.
- Designed plant layout and M&E
system
- Monitored M&E system
installation progress
- Organized training sessions on
GMP and completely prepared
essential documentation for
cGMP ASEAN auditing
Completed
LONG PHUNG KHANG
JSC.,
(Thu Duc, Ho Chi Minh)
11/2016
44.
- Counselled on designing plant
layout and master plans
- Estimated the total investment
- Designed construction drawings
and M&E system
- Supervised construction and
installation progress
- Organized training sessions on
GMP and completely prepared
essential documentation for
cGMP ASEAN auditing
On going
DANG DUONG
COSMETICS CO., LTD
(Binh Tan, Ho Chi Minh)
11/2015
45.
- Developed renovation solution
- Designed M&E system
- Organized training sessions on
GMP and completely prepared
essential documentation for
Completed
Tha Von JSC.,
(Da Lat)
03/2015
19. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 19
No Main tasks Status Client Time
cGMP ASEAN
46.
- Provide engineering design
consulting service
- Oversaw and monitored project
progress (construction and M&E
system)
- Organized training sessions on
GMP and completely prepared
essential documentation for
cGMP ASEAN
Completed
GIANG DIEN COSMETIC
E.B.C CO.,LTD
(Dong Nai)
11/2014
47.
- Designed M&E system for Gia
Nguyen’s cosmetic external use
products manufacturing plant
complied with GMP-WHO
Completed
SAGEN JSC
(Phu Nhuan - TP.HCM)
06/2011
48.
- Designed construction drawings
and M&E system
- Organized training sessions on
GMP and completely prepared
essential documentation for
cGMP ASEAN auditing
Completed
FAMILIAR CO., LTD
(Binh Tan -TP.HCM)
12/2012
49.
- Provided engineering design
consulting service for
manufacturing area,
laboratories and storages
Completed
PRETTY STAR CO.,LTD
(Quan 7, Ho Chi Minh)
11/2015
50.
- Organized training sessions on
GMP and completely prepared
essential documentation for
cGMP ASEAN auditing
Completed
BODETA COSMETIC
(Tan Binh, TP.HCM)
3/2015
51. - Designed plant layout and Completed THAI HUONG 9/2016
20. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 20
No Main tasks Status Client Time
proposed renovation solutions
for M&E system
- Organized internal training
sessions and prepared
application dossier to acquire
“Certificate of eligibility for
cosmetic manufacturing”
INVESTMENT CO., LTD
(Hoang Mai, Ha Noi)
52.
- Designed a master plan and
determined plant layout
- Estimated total investment
Completed
KOSEI INTERNATIONAL
CO.,LTD
(Yen My, Hung Yen)
9/2016
53.
- Designed a master plan in
accordance with GMP/GLP/GSP
guidelines
- Estimated total investment
Completed
LIFE ESSENCE CO., LTD
(District 1, TP.HCM)
10/2016
C Projects on Veterinary medicines manufacturing plants in compliance with GMP WHO
54.
- Provide engineering design
consulting service
On going
UNI LONGS CO.LTD
(Khanh Hoa)
4/2018
55.
- Provided engineering design
consulting service
- Oversaw and monitored project
progress
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
On going
ANH QUOC
PRODUCTS., JSC
(Gia Lam, Ha Noi)
9/2017
21. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 21
No Main tasks Status Client Time
56.
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
NAM DUNG CO., LTD
(Van Lam, Hung Yen)
12/2013
57.
- Counselled on plant operation
and management in accordance
with GMP - WHO
Completed
GREENLAB JSC.,
(Gia Lam, Ha Noi)
12/2013
58.
- Assisted in completing M&E
system designs ;
- Monitored M&E system setup
progress
- Prepared documentation to
acquire GMP certification for
powder production line
- Organized comprehensive
training sessions on QA, QC and
manufacturing requirements as
well as Prepared documentation
to renew GMP certification for
liquid medicine
Completed
HUNG NGUYEN JSC.,
(My Hao, Hung Yen)
09/2013
59.
- Oversaw and monitored project
progress (construction and
equipment installation)
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP auditing
Completed
VETERCO CO., LTD
(Ninh Kieu - Can Tho)
06/2013
22. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 22
No Main tasks Status Client Time
60.
- Assisted in completing M&E
system designs ;
- Monitored M&E system setup
progress
- Prepared documentation to
acquire GMP certification for
powder production line
- Organized comprehensive
training sessions on QA, QC and
manufacturing requirements as
well as Prepared documentation
to renew GMP certification for
liquid medicine
Completed
ASIA ANIMAL
PHARMACEUTICAL CO..
LTD
(Cai Rang - Can Tho)
04/2013
61.
- Developed a master plan,
designed conceptual drawings
and estimated cost plans for
construction package and M&E
system
- Oversaw and monitored project
progress of construction and
equipment installation;
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
CAI LAY VETERINARY
PHARMACEUTICAL
JSC.,
(Cai Lay -Tien Giang)
10/2012
62.
- Provided consulting service of
transferring manufacturing
technology of veterinary
medicines
Completed
SANDO CO.,LTD
(District 12– TP.HCM)
05/2012
63.
- Counselled on completing plant
designs (construction and
auxiliary facilities drawings and
Completed
KYOTO BIKEN HANOI
LABORATORIES CO.,
05/2012
23. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 23
No Main tasks Status Client Time
equipment)
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
LTD (Japan)
(Thang Long II Industry
Zone - Hung Yen)
64.
- Oversaw and monitored project
progress (construction and
equipment installation)
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
TRAVETCO - 1/5
VETERINARY MEDICINE
CO., LTD
(Ninh Kieu- Can Tho)
06/2012
65.
- Oversaw and monitored project
progress (construction and
equipment installation)
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
UV CO.LTD
(Binh Tan - TP.HCM)
02/2012
66.
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
VIET THO TRADING -
PRODUCT Co., Ltd
(Trang Bom - Dong Nai)
02/2012
67.
- Provided engineering design
consulting service for
manufacturing area, and
laboratories
- Oversaw and monitored
construction and installation
progress
- Organized training sessions on
Completed
VIET NAM GREENVET
JSC – PHU THAI GROUP
(Gia Lam -Ha Noi)
01/2012
24. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 24
No Main tasks Status Client Time
GMP and completely prepared
essential documentation for
GMP WHO auditing
68.
- Provided engineering design
consulting service for
manufacturing area, and
laboratories
- Oversaw and monitored
construction and installation
progress
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
HUNG NGUYEN JSC.,
(My Hao, Hung Yen)
06/2011
69.
- Oversaw and monitored
construction and installation
progress
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing.
Completed
ASIA ANIMAL
PHARMACEUTICAL CO..
LTD
(Cai Rang - Can Tho)
06/2011
70.
- Oversaw and monitored
construction and installation
progress
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
MARPHAVET .,JSC
(Pho Yen - Thai
Nguyen)
05/2011
D Projects on Medical devices manufacturing plants complied with GMP & ISO 13485
71. - Organized training sessions on Completed AMVI BIOTECH INC., 07/2013
25. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 25
No Main tasks Status Client Time
GMP and completely prepared
essential documentation to
acquire GMP certification for
AMVI’s factory
(TP.HCM)
72.
- Conducted feasibility study for
UHC’s medical device
manufacturing plant complied
with GMP
Completed
UNITED HEALTHCARE
CO., LTD
(TP.HCM)
06/2013
73.
- Designed the master plan
- Designed floor plans for
manufacturing area,
laboratories, storages and
auxiliary facilities
- Estimated total investment
Completed
BEKAMIN CO.,LTD
(Hoc Mon, TP.HCM)
08/2016
E Projects on Pharmaceutical packaging production
74.
- Developed a master plan for
manufacturing area,
laboratories and auxiliary
system in compliance with GMP
- Designed floor plans for
manufacturing area and
laboratories
- Estimated total investment
Completed
DUY TAN PLASTICS
CORP.
(TP.HCM)
11/2013
75.
- Provided engineering design
consulting service for
manufacturing area, and
laboratories
- Designed drawings and
estimated cost plan for M&E
system
- Oversaw and monitored
Completed
HONG HAI DANG
PLASTICS CO., LTD
(Binh Minh Town –
Vinh Long)
05/2013
26. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 26
No Main tasks Status Client Time
construction and installation
progress
76.
- Designed floor plans for
manufacturing area and
laboratories;
- Designed drawings and
estimated cost plan for M&E
system
- Oversaw and monitored project
progress
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
PHUC DUC CO., LTD
(Cai Rang – Can Tho)
05/2013
77.
- Designed floor plans for
manufacturing area and
laboratories;
- Designed drawings and
estimated cost plan for M&E
system
Completed
HUNG PHU MEDICAL
GLASS JCS.,
(District 8 –TP.HCM)
05/2013
78.
- Designed floor plans for
manufacturing area and
laboratories
- Designed drawings and
estimated cost plan for M&E
system as well as estimated
total investment
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
LONG AN TRƯƠNG
SONG TRADING AND
PRODUCING CO., LTD
(Ben Luc - Long An)
03/2013
27. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 27
No Main tasks Status Client Time
79.
- Designed drawings and
estimated cost plan for M&E
system
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
AGRICULTURE
PRINTING AND
PACKAGING JSC.,
(Thanh Tri -Ha Noi)
03/2013
80.
- Designed floor plans for
manufacturing area and
laboratories
- Designed drawings and
estimated cost plan for M&E
system
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
LIKSIN CORP – PAPER
PACKAGING BRANCH
(Duc Hoa – Long An)
02/2013
81.
- Designed floor plans for
manufacturing area and
laboratories
- Designed drawings and
estimated cost plan for M&E
system
- Monitored construction and
installation progress of M&E
system
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
CP PLASTIC LONG AN
CO., LTD
(Binh Tan – TP.HCM)
02/2013
28. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 28
No Main tasks Status Client Time
82.
- Designed floor plans for
manufacturing area and
laboratories
- Designed drawings and
estimated cost plan for M&E
system
- Monitored construction and
installation project progress
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
GIA PHAT TRADING
CO., LTD
(Hoc Mon –TP.HCM)
02/2013
83.
- Designed floor plans for
manufacturing area and
laboratories
- Designed drawings and
estimated cost plan for M&E
system
- Monitored construction and
installation project progress
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
DONG AU TRADING
CO., LTD
(Que Vo - Bac Ninh)
01/2013
84.
- Monitored construction and
installation project progress
- Organized training sessions on
GMP and completely prepared
essential documentation for
GMP WHO auditing
Completed
TAN THANH CO., LTD
(Tan Phu -TP.HCM)
09/2012
29. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 29
No Main tasks Status Client Time
85.
- Determined plant layout and
Counselled on designing master
plans
- Estimated total investment
Completed
DAIWA PLASTICS
VIETNAM
(District 7, TP. HCM)
12/2015
F Projects on Health supplements
86.
- Designed plant layout
- Designed M&E system
Completed
NATUCON SINGAPORE
VIET NAM CO., LTD
(Binh Duong)
10/2016
87.
- Designed plant layout,
particularly layout of
manufacturing area and
storages
- Estimated total investment
Completed
BLUE CO., LTD
(Ha Dong, Ha Noi)
4/2016
88.
- Counselled on transferring milk
powder manufacturing
technology
Completed
GREAT BEAR
INTERNATIONAL CO.,
LTD
(District 6, Ho Chi
Minh)
06/2012
89.
- Edited engineering drawings
- Organized training sessions on
GMP guidelines
- Prepared essential
documentation to acquire GMP-
HACCP certification
Completed
NUTIFOOD JSC.,
(Binh Duong)
10/2013
90.
- Provided consulting service on
technology
- Proposed renovation solutions
Completed
VITADAIRY CORP.,
(Ha Noi)
8/2014
30. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 30
No Main tasks Status Client Time
and Designed M&E system
- Assisted in tenders selection
process and Monitored
construction and installation
progress.
91.
- Provided engineering design
consulting service
Completed
MEDIBEST JSC.,
(Thanh Xuan, Ha Noi)
05/2015
92.
- Developed feasible solutions to
improve air conditioning system
in cleanrooms in milk
manufacturing plant
Completed
ENERIGHT NURFO
CO.,LTD
(Vinh Phuc)
07/2015
GMPc Vietnam Joint-Stock Company
31. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 31
II. STAFF
1. Team of specialists
Collecting a team of specialists, we create a distinctive yet competitive advantage
in the field of GxPs (GMP, GLP, GDP) consultancy. While our board of directors possess a
wealth of experience in building and managing a great number of construction GMP
plant projects such as Lili of France, Savipharm, DHG pharmaceutical JSC., GMPc’s experts
had been training and working in multinational enterprises like Unilever Vietnam,
Panasonic (Japan), LG (Korea) and so on. Hence, we had built a professional team that
can successfully combine and utilize their profound knowledge about GMP with their
experience to propose the most feasible and flexible solutions in order to fulfill
Customer’s needs.
2. List of GMPc’s employees
No Name Degree Position
1. Huong Xuan Dao
Bachelor of
Engineering
Founder & Chairman
2. Giang The Nguyen
Bachelor of Electrical
engineering
M&E Manager
(in Hanoi)
3. Long Van Do
Bachelor of Electrical
engineering
M&E Engineer
(in Hanoi)
4. Nghia Duc Nguyen
Bachelor of
Construction
Construction Supervisor
(in Hanoi)
5. Hien Thu Le Bachelor of Pharmacy
GMP Specialist
(in Hanoi)
6. Giang Thuy Le Bachelor of Pharmacy
GMP Specialist
(in Hanoi)
7. Oi Van Nguyen
Bachelor of Electrical
engineering
M&E Engineer
(in Ho Chi Minh)
8. Nghiem Huu Nguyen Bachelor of Pharmacy
GMP Specialist
(in Ho Chi Minh)
32. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 32
No Name Degree Position
9. Nhu Thi Quynh Phan Bachelor of Pharmacy
GMP Specialist
(in Ho Chi Minh)
33. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 33
PART 3
APPENDICES
34. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 34
Appendix 01: Projects Images
DANG DUONG COSMETICS CO., LTD – TP. Ho Chi Minh
DHG PHARMACEUTICAL JSC. – Can Tho
Kho bảo quản tiêu chuẩn GSP Codupha – TP.HCM
35. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 35
CODUPHA CENTRAL PHARMACEUTICAL JSC.– TP. Ho Chi Minh
KYOTO BIKEN HANOI LABORATORIES CO., LTD – Hung Yen
36. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 36
CAI LAY VETERINARY PHARMACEUTICAL JSC., MEKOVET - Tien Giang
BIOSPRING HOA LAC.,JSC – Ha Noi
37. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 37
HANOI PHARMACEUTICAL AND MEDICAL EQUIPMENT IMPORT – EXPORT JSC., - Ha Noi
NIPPON CHEMIPHAR - KCN. VSIP Binh Duong
38. GMPc Vietnam Joint Stock Company
GMP Investment Solution – Construction - Operation
Get GMP – Get what you want! Page 38
HAPPY SECRET – Nha Be – Tp HCM
Tìm hiểu thông tin thêm về GMPc và 60+ Dự án Nhà máy GMP do GMPc tư vấn Đầu tư
GMPc VIETNAM JOINT-STOCK VIETNAM