This seminar basically explains about GMP and cGMP. It explains about thecode of federal regulation (CFR). After studying this seminar, the reader will get a detail knowldege pf what is GMP, cGMp, objectives and policies of cGMP. all the part of CFR part 21 is discussed in detail. Here in this seminar, main focus is given on the layout of the buildings and the equipment and its maintenant part. Layout of building includes the building design, construction of building and the plans. The life stage of equipments, how tp select a equipment befor epurchase i.e purchase specifications and the cleaninga nd the maintenance part of the equipments with examples are discussed in detail.
The document discusses developing a validation master plan (VMP) for a new pharmaceutical facility. Key points:
- A VMP comprehensively describes validation requirements and plans for meeting them. It covers production, storage, utilities, and staff areas.
- The VMP sets goals and limits for validation projects. It defines the scope and systems included.
- Developing the VMP involves determining standards, qualifications for design, installation, operation, and performance, documentation requirements, and change control procedures.
- User requirement specifications (URS) are critical documents that validation is dependent on. Developing clear, testable URS in multiple levels is important, especially for software.
This document provides an overview of pharmaceutical validation and calibration processes. It discusses the objectives of validation which include reducing regulatory risks and defects. The scope of validation covers analytical, facilities, manufacturing, product design, cleaning, instrumentation, utilities, materials and equipment. A validation master plan outlines the validation strategy and includes qualification methods, personnel responsibilities, schedules, documentation and change control. Similarly, a calibration master plan ensures equipment is routinely calibrated against reference standards to ensure proper performance and measurement traceability.
This document provides an introduction to validation in the pharmaceutical industry. It discusses the origins and need for validation to ensure quality and control costs. The document outlines the key types of validation: prospective, retrospective, concurrent and revalidation. It also describes the scope of validation, noting it requires appropriate infrastructure, documentation, personnel and management involvement. Validation should be performed for facilities, equipment, utilities, processes and when major changes occur to demonstrate consistency in producing products that meet specifications.
cGMP Guidelines According to Schedule MANKUSH JADHAV
This document provides an overview of cGMP guidelines according to Schedule M. It defines cGMP and outlines key areas that must be addressed including personnel, premises, equipment, standard operating procedures, raw materials, self inspections, master formula records, batch manufacturing records, warehousing, and validation. The guidelines ensure quality products are consistently produced and that quality is built into every step of the manufacturing process.
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
The document discusses developing a validation master plan (VMP) for a new pharmaceutical facility. Key points:
- A VMP comprehensively describes validation requirements and plans for meeting them. It covers production, storage, utilities, and staff areas.
- The VMP sets goals and limits for validation projects. It defines the scope and systems included.
- Developing the VMP involves determining standards, qualifications for design, installation, operation, and performance, documentation requirements, and change control procedures.
- User requirement specifications (URS) are critical documents that validation is dependent on. Developing clear, testable URS in multiple levels is important, especially for software.
This document provides an overview of pharmaceutical validation and calibration processes. It discusses the objectives of validation which include reducing regulatory risks and defects. The scope of validation covers analytical, facilities, manufacturing, product design, cleaning, instrumentation, utilities, materials and equipment. A validation master plan outlines the validation strategy and includes qualification methods, personnel responsibilities, schedules, documentation and change control. Similarly, a calibration master plan ensures equipment is routinely calibrated against reference standards to ensure proper performance and measurement traceability.
This document provides an introduction to validation in the pharmaceutical industry. It discusses the origins and need for validation to ensure quality and control costs. The document outlines the key types of validation: prospective, retrospective, concurrent and revalidation. It also describes the scope of validation, noting it requires appropriate infrastructure, documentation, personnel and management involvement. Validation should be performed for facilities, equipment, utilities, processes and when major changes occur to demonstrate consistency in producing products that meet specifications.
cGMP Guidelines According to Schedule MANKUSH JADHAV
This document provides an overview of cGMP guidelines according to Schedule M. It defines cGMP and outlines key areas that must be addressed including personnel, premises, equipment, standard operating procedures, raw materials, self inspections, master formula records, batch manufacturing records, warehousing, and validation. The guidelines ensure quality products are consistently produced and that quality is built into every step of the manufacturing process.
This document discusses various quality control and documentation procedures in the pharmaceutical industry. It includes 3 key points:
1. It discusses the importance of documentation in defining specifications, methods, providing an audit trail and ensuring authorized personnel have necessary information. This includes documents like specifications, batch production records, SOPs etc.
2. It describes procedures for developing key documents like master formulas, batch manufacturing records, audit plans and reports. This ensures uniform processes and allows tracing of batch history.
3. It discusses quality audits which systematically examine if quality activities comply with arrangements and objectives. This includes internal audits as well as those imposed by regulators or customers.
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
This document discusses various types of documentation required in the pharmaceutical industry, including master formula records (MFR), drug master files (DMF), and generic drug development. It defines MFRs as approved master documents that describe the full manufacturing process for a specific batch size. It provides details on the content required for MFRs based on guidelines from WHO, Health Canada, and the US CFR. It also discusses the purpose and types of DMFs submitted to the FDA, including Type 1 for manufacturing facilities, Type 2 for drug substances/products, and others. Finally, it briefly mentions the Hatch-Waxman Act as it relates to generic drug development.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
USFDA guidelines on process validation a life cycle approachRx Ayush Sharma
The document summarizes the US FDA's 2011 guidance on process validation, which outlines a lifecycle approach. It discusses the three stages of process validation according to the guidance: (1) Process Design which defines the commercial process based on development, (2) Process Qualification which evaluates the process's capability for commercial manufacturing, and (3) Continued Process Verification which gains ongoing assurance that the process remains in control during routine production. The lifecycle approach integrates validation strategies from previous guidelines and emphasizes continual process improvement, understanding sources of variation, and controlling variation to ensure consistent quality.
The document discusses current Good Manufacturing Practices (cGMP) according to the US Food and Drug Administration (FDA). It provides an overview of cGMP principles and requirements, including proper facilities and equipment design, documentation practices, and quality control. The document also summarizes key cGMP regulations and guidelines for manufacturing, processing, packaging, holding, testing, and distributing drug products. It outlines the important documents, facilities, equipment, production processes, and quality systems that must be in place to ensure consistent production of safe, effective pharmaceuticals.
Mr. Krushnakant K. Wable gave a presentation on current good manufacturing practices (cGMP) under the guidance of Dr. Sonali Mahaparale and Dr. D. Y. Patil. The presentation defined cGMP as regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It also explained that cGMP helps assure the identity, strength, quality and purity of drug products. The presentation covered key components of cGMP like personnel, premises, equipment, standard operating procedures, raw materials, self inspections, and warehousing. It emphasized that cGMP helps prevent contamination, mix-ups, failures and errors to ensure products meet quality standards.
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
The document discusses validation of pharmaceutical processes. It defines validation as establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. There are several types of validation including process validation to ensure consistency in manufacturing, cleaning validation to minimize contamination, equipment validation to ensure equipment works correctly, and validation of analytical methods to establish test method performance. Proper documentation is essential for validation including a validation master plan, protocols, reports and standard operating procedures.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
This document describes quality control tests performed on suppositories, including weight variation testing to ensure suppositories are uniformly sized, hardness testing to evaluate structural integrity, disintegration testing to assess dissolution rate, and drug content testing to verify active ingredient levels. Dissolution testing was also conducted using a basket apparatus to analyze drug release over time in vitro. Finally, short term stability studies were performed on promising formulations by storing samples at room temperature and refrigeration for 6 weeks and testing for drug content and dissolution profile.
This document discusses the process validation of capsules. It begins by providing background on validation and defining process validation according to the FDA. It then describes the three main types of process validation: prospective, concurrent, and retrospective. Key documents used in validation like the validation master plan, validation protocols and reports, and standard operating procedures are also outlined. The validation process for capsules is then detailed, including evaluating the capsule composition, selecting the encapsulation process and equipment, and testing the encapsulation step. Critical factors considered during encapsulation like the technique used and encapsulation speed are also summarized.
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
The document discusses concepts related to cGMP (current good manufacturing practices) and industrial management. It covers several topics related to cGMP compliance including objectives of cGMP, layout of buildings and facilities, production organization, material management, inventory management, and quality control. It also discusses concepts like plant layout, material procurement, inventory costs, and techniques for inventory management. The overall document provides an overview of various aspects involved in ensuring cGMP compliance and efficient industrial management practices.
The document discusses regulations governing Good Manufacturing Practices (GMP). It aims to provide an understanding of GMP regulations and their application and interpretation. The key GMP regulations cover the drug, medical device, food, and blood industries. GMP regulations provide flexibility for manufacturers but can also lead to confusion in interpretation. Subparts cover organization and personnel qualifications, facilities and equipment requirements, material and component controls, production and process controls, and documentation.
Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào chế không vô trùng. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
This document discusses various types of documentation required in the pharmaceutical industry, including master formula records (MFR), drug master files (DMF), and generic drug development. It defines MFRs as approved master documents that describe the full manufacturing process for a specific batch size. It provides details on the content required for MFRs based on guidelines from WHO, Health Canada, and the US CFR. It also discusses the purpose and types of DMFs submitted to the FDA, including Type 1 for manufacturing facilities, Type 2 for drug substances/products, and others. Finally, it briefly mentions the Hatch-Waxman Act as it relates to generic drug development.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
USFDA guidelines on process validation a life cycle approachRx Ayush Sharma
The document summarizes the US FDA's 2011 guidance on process validation, which outlines a lifecycle approach. It discusses the three stages of process validation according to the guidance: (1) Process Design which defines the commercial process based on development, (2) Process Qualification which evaluates the process's capability for commercial manufacturing, and (3) Continued Process Verification which gains ongoing assurance that the process remains in control during routine production. The lifecycle approach integrates validation strategies from previous guidelines and emphasizes continual process improvement, understanding sources of variation, and controlling variation to ensure consistent quality.
The document discusses current Good Manufacturing Practices (cGMP) according to the US Food and Drug Administration (FDA). It provides an overview of cGMP principles and requirements, including proper facilities and equipment design, documentation practices, and quality control. The document also summarizes key cGMP regulations and guidelines for manufacturing, processing, packaging, holding, testing, and distributing drug products. It outlines the important documents, facilities, equipment, production processes, and quality systems that must be in place to ensure consistent production of safe, effective pharmaceuticals.
Mr. Krushnakant K. Wable gave a presentation on current good manufacturing practices (cGMP) under the guidance of Dr. Sonali Mahaparale and Dr. D. Y. Patil. The presentation defined cGMP as regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It also explained that cGMP helps assure the identity, strength, quality and purity of drug products. The presentation covered key components of cGMP like personnel, premises, equipment, standard operating procedures, raw materials, self inspections, and warehousing. It emphasized that cGMP helps prevent contamination, mix-ups, failures and errors to ensure products meet quality standards.
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
The document discusses validation of pharmaceutical processes. It defines validation as establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. There are several types of validation including process validation to ensure consistency in manufacturing, cleaning validation to minimize contamination, equipment validation to ensure equipment works correctly, and validation of analytical methods to establish test method performance. Proper documentation is essential for validation including a validation master plan, protocols, reports and standard operating procedures.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
This document describes quality control tests performed on suppositories, including weight variation testing to ensure suppositories are uniformly sized, hardness testing to evaluate structural integrity, disintegration testing to assess dissolution rate, and drug content testing to verify active ingredient levels. Dissolution testing was also conducted using a basket apparatus to analyze drug release over time in vitro. Finally, short term stability studies were performed on promising formulations by storing samples at room temperature and refrigeration for 6 weeks and testing for drug content and dissolution profile.
This document discusses the process validation of capsules. It begins by providing background on validation and defining process validation according to the FDA. It then describes the three main types of process validation: prospective, concurrent, and retrospective. Key documents used in validation like the validation master plan, validation protocols and reports, and standard operating procedures are also outlined. The validation process for capsules is then detailed, including evaluating the capsule composition, selecting the encapsulation process and equipment, and testing the encapsulation step. Critical factors considered during encapsulation like the technique used and encapsulation speed are also summarized.
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
The document discusses concepts related to cGMP (current good manufacturing practices) and industrial management. It covers several topics related to cGMP compliance including objectives of cGMP, layout of buildings and facilities, production organization, material management, inventory management, and quality control. It also discusses concepts like plant layout, material procurement, inventory costs, and techniques for inventory management. The overall document provides an overview of various aspects involved in ensuring cGMP compliance and efficient industrial management practices.
The document discusses regulations governing Good Manufacturing Practices (GMP). It aims to provide an understanding of GMP regulations and their application and interpretation. The key GMP regulations cover the drug, medical device, food, and blood industries. GMP regulations provide flexibility for manufacturers but can also lead to confusion in interpretation. Subparts cover organization and personnel qualifications, facilities and equipment requirements, material and component controls, production and process controls, and documentation.
Phụ lục 5. Hướng dẫn chuẩn bị hệ thống HVAC cho các sản phẩm thuộc dạng bào chế không vô trùng. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
1. GMP aims to ensure quality, safety and efficacy of pharmaceutical products through proper manufacturing and quality control.
2. Key aspects of GMP include facilities and equipment design, sanitation, personnel training, validation processes, documentation systems, and quality control testing.
3. Adhering to GMP guidelines helps manufacturers consistently produce pharmaceuticals that meet specifications and protects patients from defective products.
Cleaning validation is important to ensure safety and prevent contamination during pharmaceutical production. It involves collecting data to prove cleaning procedures consistently remove residues to acceptable limits. Key aspects of validation include defining cleaning procedures, acceptance criteria, sampling methods, and analytical techniques. Validation should continue if procedures or products change. Overall, cleaning validation demonstrates equipment is suitably cleaned between batches to maintain quality as required by cGMP regulations.
The document discusses several auxiliary facility programs that are important components of a GMP quality system, including pest control, cleaning programs, drawing control, engineering change control, spare parts management, lubricant control, and qualification of maintenance technicians and outside contractors. It emphasizes that written procedures and documentation are required for these programs to ensure facilities and equipment are properly maintained and calibrated.
This document discusses guidelines for equipment selection, purchase, specification, and maintenance in the pharmaceutical industry. It begins by defining equipment and its importance in pharmaceutical manufacturing. It then outlines the various stages of an equipment's lifecycle from the decision to purchase through maintenance and disposal. The document reviews guidelines from organizations like WHO, USFDA, MHRA, and others regarding factors to consider in equipment design, cleaning, identification, calibration, and record keeping. It emphasizes that equipment must be suitable for its intended use and not negatively impact product quality.
This presentation describes Schedule M of Drugs & Cosmetic Act. It consists of Good Manufacturing Practices (GMP) for the manufacturing of drugs. Detailed guidelines about factory premises, machinery, process, quality control, etc. have been given.
This document provides a 3-paragraph summary of the PAS 220:2008 public available specification:
The PAS 220:2008 specification provides detailed guidance for implementing prerequisite programs (PRPs), which are basic conditions and activities necessary to maintain hygiene and prevent food contamination throughout the food chain. It is intended to be used in conjunction with BS EN ISO 22000 as supporting documentation for food safety management systems. The PAS specifies requirements for the construction, design, and maintenance of facilities and equipment; control of purchased materials; cleaning and sanitation programs; pest control; and employee hygiene practices. It aims to control food safety hazards and meet the requirements of BS EN ISO 22000 for any organization involved in food manufacturing.
The document
The document discusses current good manufacturing practices (cGMP) for active pharmaceutical ingredients (APIs). It lists major international codes of cGMP such as those from the WHO, EU, US FDA, ISO, and ICH. It also provides references and websites for cGMP standards. The document then discusses topics including validation, validation master plans, qualification types, calibration, facilities, equipment, air handling units, and containment practices.
Presentation on CIP & COP process in Food Manufacturing Facilities.pptxMimmaafrin1
CIP and COP are cleaning processes used in food manufacturing. CIP involves cleaning equipment internally using cleaning agents without disassembly. It involves pre-rinsing, alkaline cleaning, acid cleaning, and final rinsing/sanitization. COP requires disassembling equipment for manual cleaning before reassembly. Key factors for effective CIP and COP are proper cleaning agents, temperature/pressure control, time management, efficient equipment, and validation/verification. Requirements include adequate equipment design, appropriate cleaning agents, effective circulation, temperature/time control, validation/testing, training, and documentation. Benefits are improved product quality, safety, efficiency, regulatory compliance, extended equipment lifespan, and customer confidence.
The GMP Operations Manager is responsible for overseeing the implementation and sustained operations of world-class technical cleaning and sanitization programs to include cGMP space, semi-conductor, clean rooms, laboratory, data and other critical environments.
The document discusses pharmaceutical validation requirements according to various regulatory bodies like USFDA, EU, WHO and cGMP. It explains the manufacturing process model involving three stages - process design, process qualification and continued process verification. It also describes the user requirement specification document and the different phases of qualification - design qualification, installation qualification, operational qualification and performance qualification. The qualifications are methods to demonstrate that equipment and processes will consistently produce products meeting quality standards.
Principles of GMP Training Module ProgramLucky Saggi
Good manufacturing practices (GMP) are regulations and guidelines for ensuring that products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from facilities and equipment to processes and quality control. Following GMP procedures is important for guaranteeing high quality, safe products and compliance with regulations. Regular audits help ensure ongoing adherence to GMP standards.
The document summarizes current good manufacturing practices (cGMPs) for pharmaceutical manufacturing as regulated by the FDA. It discusses that cGMPs provide quality standards to ensure identity, strength, quality and purity of drugs. Key aspects of cGMPs covered include facilities and equipment design, production process controls, packaging and labeling, quality testing, and record keeping. Adherence to cGMPs helps assure proper design and monitoring of manufacturing to maintain compliance.
This document provides guidelines on heating, ventilation and air conditioning (HVAC) systems for manufacturing solid dosage pharmaceutical products. It discusses HVAC system design considerations to protect products, personnel and the environment. Key recommendations include ensuring HVAC systems provide appropriate temperature, humidity and air quality during manufacturing and storage. HVAC systems should be designed at the concept stage and qualified to demonstrate they will perform as intended. The guidelines are meant to complement good manufacturing practice standards.
To compare GMP requirement of India, US and Europe for tablets.Aakashdeep Raval
The document discusses Good Manufacturing Practice (GMP) requirements for tablet manufacturing in India, the US, and Europe. It provides an in-depth overview of key GMP requirements for tablet production in India, covering general facility requirements, warehousing, production areas, ancillary areas, quality control, personnel, manufacturing operations, equipment, documentation, quality assurance, and validation. The guidelines outline aspects of production and testing that impact quality, including clearly defined and controlled manufacturing processes, change control, training, facilities, equipment, and documentation.
CCS Contamination Control Strategy Presentation.pdfmidohamada2
This document discusses contamination control from a product and facility perspective. It defines contamination and cross-contamination, and outlines the regulatory requirements around preventing them. Contamination can occur through airborne transfer, mechanical transfer, retention in equipment or facilities, or mix-ups. Key controls to prevent these types of contamination include closed systems, containment, proper facility design and HVAC systems, cleaning validation, equipment design, labeling and procedures. Failure to control contamination can pose risks to patient health and result in regulatory issues. A quality risk management approach is recommended to evaluate and control contamination risks from facilities, equipment, processes and products.
The document discusses FDA regulations for quality system requirements regarding medical devices. It specifically discusses 21 CFR Part 820, which are the Current Good Manufacturing Practice regulations that medical device manufacturers must follow to ensure their products are safe and of high quality. The regulations address requirements for management responsibility, quality audits, personnel training, document controls, purchasing controls, product identification and traceability, production and process controls, labeling, handling, storage, distribution, installation, and servicing. Manufacturers must establish procedures and controls to meet the requirements in each of these areas.
Similar to Current good manufacturing practices(cGMP) (20)
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- 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
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...rightmanforbloodline
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Versio
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central19various
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler Community Health Nursing A Canadian Perspective, 5th Edition TEST BANK by Stamler Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Study Guide Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Studocu Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Course Hero Community Health Nursing A Canadian Perspective, 5th Edition Answers Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Course hero Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Studocu Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Study Guide Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Ebook Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Questions Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Studocu Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Stuvia
1. Seminar on
Current Good Manufacturing
Practice( cGMP) focusing layout of
building and equipment and its maintenance
Under the guidance of
Dr. Abdul Baquee Ahmed,
Associate professor, GIPS,
guwahati.
Presented by
Alakesh Bharali ( Roll No 1)
M. Pharm 1st semester(Pharmaceutics)
GIPS, Guwahati
2. CONTENTS
Introduction
Code of Federal regulation(CFR)
Evolution of cGMP
Objectives
Policies
CFR part 21
Layout of building and services
Building design
Construction of building
2
3. CONTENTS
Equipments and its maintenance
Life stages of equipment
Selection of equipment
Purchase specification
Cleaning and maintenance
Summary
Conclusion
References
3
4. Introduction
GMP is that part of QA, which ensures the products are
consistently produced and controlled to the quality
standards appropriate to their intended use and as required
by the marketing authorization.
cGMP refers to the current good manufacturing practice
regulations enforced by the US FDA.
cGMP provide for systems that assure proper design,
monitoring and control of manufacturing processes and
facilities.
Adherence to the cGMP regulations assure the identity ,
strength, quality and the purity of drug products
4
5. Code of federal regulations(CFR)
Portion of FDA
Divided into 50 titles
Collection of final regulations published in the
federal register
Appears in the part 210 (title 21) as per
USFDA
5
6. Evolution of cGMP
1941: Initiation of GMP( after sulfanilamide tragedy
in 1937)
1957: Thalidomide tragedy
1962: Kefauver-Harris Amendment act
1963: Establishment of GMP for drugs( 1st
publication)
1975: cGMP for blood and components final rule
1978:cGMP for drugs and medical devices( Major
revision)
6
8. Policies
To design and construct the facilities and
equipments properly
Follow written procedures and instructions
Document work
Validate work
Monitor facilities and equipments
Protect against contamination
Control components and product related processes
Conduct periodic audits
8
9. CFR Part 21
Subpart A: General provisions
211.1. Scope
211.3. Definitions
Subpart B: Organization and personnel
211.22. Responsibilities of QC unit
211.25. Personnel qualifications
211.28. Personnel responsibilities
211.34. Consultants
9
10. Contdd..
Subpart C: Buildings and facilities
211.42. Design and construction features
211.44. Lighting
211.46. ventilation, air filtration, air heating and
cooling
211.48. Plumbing
211.50. Sewage and refuse
211.52. Washing and toilet facilities
211.56. Sanitation
10
11. Contdd..
Subpart D: equipment
211.63. Equipment design, size and location
211.65. Equipment construction
211.67. Equipment cleaning and maintenance
211.68. Automatic, mechanical and electronic
equipment
211.72. Filters
11
12. Contdd..
Subpart E: Control of components and drug
product containers and closures
211.80. General requiremets
211.82. Receive and storage of untested
components, drug product containers
211.84. Testing and approval or rejection of
components
211.89. Rejected components ,containers and
closures
12
13. Contdd..
Subpart F: Production and process control
211.100. Written procedures, deviations
211.101. Charge-in of components
211.103. Calculation of yield
211.105. Equipment identification
211.110. Sampling and testing of in process
materials and drug products
211.115. Reprocessing
13
14. Contdd..
Subpart G: Packaging and labeling control
211.112. Materials examination and usage criteria
211.125. Labeling issuance
211.130. Packaging and labeling operations
211.134. Drug product inspection
Subpart H: Holding and distribution
211.142. Warehousing procedures
211.150. Distribution procedures
14
15. Contdd..
Subpart I: Laboratory controls
211.160. General requirements
211.165. Testing and release for distribution
211.166. Stability testing
211.170. Reserved samples
211.173. Laboratory animals
211.176. Penicillin contamination
15
16. Contdd..
Subpart J: Records and reports
211.182. Equipment cleaning and use log
211.186. Master production and control records
211.188. BPR
211. 192. Production record review
211.194. Laboratory records
Subpart K: Returned and salvaged products
211.204. Returned drug products
16
17. Layout of buildings and services
Designed according to cGMP practice which
ensures:
Prevention of cross contamination
Proper air handling system
Proper cleaning and sanitary facilities
Proper lighting
Proper plumbing and proper washing
17
18. Contdd..
Layout
Organized planned inter department and intra
department arrangement
Proper layout helps in:
Increase productivity
Helps in proper utilization of men, material, money and
machines
Types of layout:
Circular flow
Parallel flow
Cross over traffic
18
23. Contdd..
Adequate space for future extension
Availability of water supply(quality and quantity),
power, fuel sewage and waste stream removal
Availability of public transport
Proximity of undesirable activity
Accessibility of interrelated operation
Advocating for law to restrict undesirable
activities while allowing anticipated development
23
24. Contdd..
Principle:
Minimize risks of errors
Permit effective maintenance
Avoid cross contamination, build up of dirt and
dust
Avoid any adverse effect on the quality of
products
24
25. Contdd..
Design:
Process flow(circular,parallel and crosstraffic)
Material flow( Product, raw materials, wastes)
Personnel flow( Manufacturing personnel
maintenance personnel, QA and QC personnel)
Equipment flow
25
27. Construction of building
Floor:
Sufficient resistance to abrasion, impact, acid
action and temperature
High strength and high performance concretes
Foundations for vibrating machinery should be
placed upon rock or firm ground and it should
be separated from adjacent floor to avoid
vibrations
27
28. Contdd..
Roof system:
Lightness, strength, water proofness,
insulation, fire resistance, cost, durability and
low maintenance charges
Factors to consider: insulating value,
acoustical properties, appearance from inner
side, weight and maintenance
28
29. Contdd..
Water:
Should meet WHO guidelines for drinking
water quality
If drinking water insufficient to ensure API
quality, the appropriate specifications for
physical/ chemical attributes, total microbial
counts, objectionable organisms, endotoxins,
are called for.
29
30. Contdd..
Lighting:
Adequate lighting should be provided in all
areas to facilitate cleaning, maintenance and
proper operations.
Sewage and Refuse:
Should be disposed of in a safe , timely and
sanitary manner
Containers and pipes for waste material should
be clearly identified.
30
33. Equipments and its maintenance
Physical entity used to carry out a general or
specific activity
Can be a single piece or an integrated system
of group of equipment, ex: water mineralizing
plants, air handling unit
Quality of the manufactured product depends
on the suitability and level of technology of
the equipment.
33
37. Life stages of equipment
Equipment management has a life cycle , and
GMP covers life cycle of the equipment
Starts with decision to purchase equipment and
ends with crapping or elimination
Life cycle consists of following stages:
Decision to purchase equipment
Purchase of equipment
Qualifying , installing and validating equipment
Using the equipment
37
38. Selection of equipment
Availability of spares and servicing.
Frequency and ease of maintenance will
significantly impact on productivity and even
quality.
Equipment breakdown during processing could
effect quality
Included in the maintenance evaluation should
be the cleanability of the equipment
Construction materials and design
38
39. Purchase specifications
Why the equipment is needed?
Which operation to be performed?
What capacity the equipment should have?
How the equipment will be cleaned
Do we have trained operations to operate this
operation?
39
40. Contdd..
Factors to be considered while purchasing:
Right source
Right quality
Right quantity
Right price
Right time
Right mode of transportation
40
41. Cleaning and maintenance
Use of cleaned equipment is one of the basic step in
avoiding contamination and meeting the purity of
the product
WHO guidelines:
Washing and cleaning equipment should be
chosen and used so as to prevent contamination
Defective equipment should be removed from
production and quality control or at least clearly
labeled as defective.
41
42. Contdd..
MHRA/TGA guidelines:
Repairs and maintenance operations should not
present any hazard to the quality of the
product.
Equipment cleaning should be maintained in
scheduled basis and that should be recorded in
proper way.
42
43. Contdd..
USFDA Guidelines:
Equipment shall be cleaned , maintained and
sanitized at appropriate intervals to prevent
malfunction or contamination that would alter
the safety ,identity , strength , purity of the
drug product
Written procedures showing date, time , batch
no. shall be established and followed .
43
47. Summary
GMP IS ACTUALLY GOOD COMMON SENSE
Quality management
47
Quality assurance
GMP
Production and QC
48. Conclusion
GMP compliance is not an option.
Good practices covers all aspects of
manufacturing activities prior to apply
The role and involvement of senior
management is crucial
Is to meet quality standard of the product
48
49. References
Leon lachman, Herbert A. Lieberman, Joseph L.
kanig ,”The theory and practice of industrial
pharmacy” 3rd edition , 589-618
Gilbert S. banker, christopher T . Rhodes ,
“Modern Pharmaceutics,3rd edition, 547-554
James Swarbrick, James C. Boylon ,
“Encyclopedia of pharmaceutical technology”
volume 2, second edition, 1735-1752
Dr. Shyamala Bhaskaran (2016) , “ Industrial
pharmacy”, Birla publication, 4th edition, 315-347
49