This document summarizes a quality documentation system for a GMP bioprocessing facility. The system is divided into 5 folders: Facility, Equipment, Production, Quality Control, and Quality Assurance. Each folder contains standard operating procedures, data record forms, and other documents pertaining to that area. The aim of the documentation system is to efficiently organize operations and ensure compliance with GMP guidelines.
The document discusses the validation of a water supply system for a pharmacy college. It outlines the objectives of validation to ensure consistent production of water meeting quality specifications. The validation process includes design qualification, installation qualification, operation qualification, and performance qualification to test the system under all expected operating conditions. Key steps involve defining quality attributes, developing a validation protocol and acceptance criteria, conducting testing and data collection, and documenting the validation results.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
An audit of a microbiology laboratory involves independently reviewing the laboratory's records, operations, and procedures to evaluate efficiency, effectiveness, compliance, and risk mitigation. The objectives are to determine the quality systems in place, the knowledge and capabilities of audited staff, and whether continuous improvement is part of the culture. Principles of efficient auditing include proper preparation, documentation, adherence to methods and standard operating procedures, and staff proficiency demonstrations. Types of audits include those of contract manufacturers, contract laboratories, ingredient suppliers, and internal audits. A micro audit works backwards or forwards from samples to comprehensively evaluate microbiological control. The auditing process consists of planning, on-site information gathering, report preparation, exit meeting,
This document discusses corrective and preventive action (CAPA) systems. It defines key terms like nonconformance and defines CAPA's goals of eliminating causes of non-conformities. CAPA has two functions - corrective actions to address root causes of problems, and preventive actions to prevent reoccurrence. The document outlines objectives of an effective CAPA system and provides steps to implement corrective and preventive actions, including defining problems, identifying causes, designing measures, and ensuring documentation is updated. It stresses the importance of planning, communication, and documentation for successful CAPA execution.
This document outlines the validation process for an HVAC system used in a pharmaceutical plant. It discusses the need for HVAC systems to control contamination and provide comfortable working conditions. The validation process includes creating a validation master plan, writing user requirement specifications, designing and qualifying the system, installing and qualifying it, operating and performance qualifications, and requalification. Key validation parameters that are measured include air flow, room air changes, filter integrity, pressure differentials, particulate counts, temperature and humidity controls, and air flow patterns.
The document discusses design controls, which are a set of quality practices and procedures incorporated into the design and development process to control the design process and ensure medical device specifications meet user needs and intended use. It provides an overview of the seven key elements of design controls according to FDA regulations: design and development planning, design input, design output, design review, design verification, design validation, and design changes. It emphasizes that design controls are important for medical device safety and quality.
This document summarizes an email from i-Sight promoting their case management software. It thanks the reader for downloading a CAPA template, and explains that i-Sight's software provides a robust online platform for organizing documents, forms, and evidence related to nonconformances and the CAPA process. The software offers features like alerts, centralized access, task management, and real-time dashboards. It encourages the reader to book a demo to learn how i-Sight can help manage their business's CAPA processes.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
The document discusses the validation of a water supply system for a pharmacy college. It outlines the objectives of validation to ensure consistent production of water meeting quality specifications. The validation process includes design qualification, installation qualification, operation qualification, and performance qualification to test the system under all expected operating conditions. Key steps involve defining quality attributes, developing a validation protocol and acceptance criteria, conducting testing and data collection, and documenting the validation results.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
An audit of a microbiology laboratory involves independently reviewing the laboratory's records, operations, and procedures to evaluate efficiency, effectiveness, compliance, and risk mitigation. The objectives are to determine the quality systems in place, the knowledge and capabilities of audited staff, and whether continuous improvement is part of the culture. Principles of efficient auditing include proper preparation, documentation, adherence to methods and standard operating procedures, and staff proficiency demonstrations. Types of audits include those of contract manufacturers, contract laboratories, ingredient suppliers, and internal audits. A micro audit works backwards or forwards from samples to comprehensively evaluate microbiological control. The auditing process consists of planning, on-site information gathering, report preparation, exit meeting,
This document discusses corrective and preventive action (CAPA) systems. It defines key terms like nonconformance and defines CAPA's goals of eliminating causes of non-conformities. CAPA has two functions - corrective actions to address root causes of problems, and preventive actions to prevent reoccurrence. The document outlines objectives of an effective CAPA system and provides steps to implement corrective and preventive actions, including defining problems, identifying causes, designing measures, and ensuring documentation is updated. It stresses the importance of planning, communication, and documentation for successful CAPA execution.
This document outlines the validation process for an HVAC system used in a pharmaceutical plant. It discusses the need for HVAC systems to control contamination and provide comfortable working conditions. The validation process includes creating a validation master plan, writing user requirement specifications, designing and qualifying the system, installing and qualifying it, operating and performance qualifications, and requalification. Key validation parameters that are measured include air flow, room air changes, filter integrity, pressure differentials, particulate counts, temperature and humidity controls, and air flow patterns.
The document discusses design controls, which are a set of quality practices and procedures incorporated into the design and development process to control the design process and ensure medical device specifications meet user needs and intended use. It provides an overview of the seven key elements of design controls according to FDA regulations: design and development planning, design input, design output, design review, design verification, design validation, and design changes. It emphasizes that design controls are important for medical device safety and quality.
This document summarizes an email from i-Sight promoting their case management software. It thanks the reader for downloading a CAPA template, and explains that i-Sight's software provides a robust online platform for organizing documents, forms, and evidence related to nonconformances and the CAPA process. The software offers features like alerts, centralized access, task management, and real-time dashboards. It encourages the reader to book a demo to learn how i-Sight can help manage their business's CAPA processes.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
A primary mission of the Food and Drug Administration is to conduct comprehensive regulatory coverage of all aspects of production and distribution of drugs and drug products to assure that such products meet the 501(a)(2)(B) requirements of the Act. FDA has developed two basic strategies:
. 1) evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested and held, and
. 2) monitoring the quality of drugs and drug products through surveillance activities such as sampling and analyzing products in distribution.
FDA compliance program “ Drug Manufacturing Inpsections” (7356.002) is designed to provide guidance for implementing the first strategy. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control.
The inspectional guidance in this program is structured to provide for efficient use of resources devoted to routine surveillance coverage, recognizing that in-depth coverage of all systems and all processes is not feasible for all firms on a biennial basis. It also provides for follow-up compliance coverage as needed.
“Drug Regulations” has prepared a summary from the compliance programme and is given below in the presentation.
The two most commonly used within microbiology are
HACCP (which originated in the food industry) and FMEA
(developed for engineering). This article explores these two
approaches, first with a description of HACCP, followed by a
description and case study of FMEA in sterility testing.
Change control is a formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might effect a validated status. The intent is to determine the need for the action that would ensure that the system is maintained in a validated state.
The document discusses the validation of water supply systems for pharmaceutical use. It outlines the validation process, which includes design qualification to verify the system design, installation qualification to confirm proper installation, operation qualification to test system functionality under static conditions, and performance qualification to demonstrate consistent performance over time under normal operating conditions. Routine monitoring, maintenance, and change control procedures are also required to ensure continued system operation and water quality as specified.
This presentation discusses pre-use post-sterilization integrity testing (PUPSIT) of sterile filters. It provides background on regulatory guidance for integrity testing critical filters before and after use. Masking studies were conducted where flawed filters were exposed to blocking solutions, and in some cases the flaws were able to mask and pass post-use integrity testing. The risk of masking was found to be highly dependent on process conditions like blocking rate and solution concentration. The presentation discusses considerations for final filtration assembly design to enable PUPSIT like using redundant filters and multi-purpose ports. It addresses challenges with maintaining sterility and pressure during PUPSIT.
Statistical process control (SPC) techniques apply statistical methods to measure and analyze variation in manufacturing processes. SPC uses control charts to distinguish between common cause variation inherent to the process and special cause variation that can be assigned to a specific reason. Control charts monitor process data over time against statistical control limits. Process capability analysis compares process variation to product specifications to determine if the process is capable of meeting specifications. Key metrics like Cp, Cpk and Cpm indices quantify a process's capability relative to the specifications. For a process to have a valid capability analysis, it must meet assumptions of statistical control, normality, sufficient representative data, and independence of measurements.
This document outlines procedures for handling deviations from standard operating procedures in a cGMP environment. It defines deviations as planned or unplanned activities that differ from specified procedures. Planned deviations are deliberate temporary changes that don't affect quality, while unplanned deviations result from failures or errors. The procedures describe rules for documenting deviations, evaluating their quality impact, approving corrective actions, and filing reports. Deviations are assigned a control number and approved by quality assurance to ensure proper handling. Repeated deviations must be investigated and corrective actions taken to prevent reoccurrences.
This document provides instructions for reporting, investigating, and handling deviations from standard operating procedures and processes. It defines deviations as planned or unplanned and categorizes them based on their severity and impact on product quality. The procedure outlines the process for reporting deviations, investigating the root cause, implementing corrective and preventive actions, evaluating their effectiveness, and trending analysis. Quality assurance is responsible for approving deviation reports and deciding if batches can be released.
The document discusses six quality assurance systems for pharmaceutical manufacturers: quality management systems, production systems, facilities and equipment systems, materials management and quality control systems, documents and records systems, and management review and quality planning systems. It provides details on each system's objectives, requirements, and goals to ensure compliance with cGMP regulations. The production system section specifies requirements for batch tracking, process validation, verification of critical steps, and review of batch records. The facilities and equipment system outlines areas for separate clean and dirty operations and standards for building materials, air handling, and temperature control.
Qualification of membrane filtration apparatusPRAVADA
This document discusses the validation of membrane filtration processes. It defines qualification as ensuring equipment is properly installed and works as expected. There are four types of qualification: design, installation, operational, and performance. Membrane filtration separates solids from liquids using a porous membrane. Validation of membrane filters includes testing reproducibility, sterilization, integrity, operating conditions, inertness, antimicrobial activity, endotoxins, and toxicity to ensure the filter performs as intended. Regular performance qualification is important to check the filter maintains consistent performance over time.
This document discusses process validation. It defines process validation as establishing documented evidence that a process will consistently produce a product meeting its predetermined specifications. The key aspects of process validation are to obtain consistent and reliable data, demonstrate that the process remains in control, and show the process works as intended. There are different types of process validation including prospective, retrospective, and concurrent validation. Process validation involves multiple phases from process design and qualification to process verification and monitoring. It is important for quality, safety, efficacy and compliance with global regulatory agencies.
The document outlines various quality management topics and provides an index with page numbers for each topic. Some of the key topics covered include: site master file, validation master plan, quality manual, change control, deviation, market complaint, product recall, CAPA, process validation, stability studies, analytical method validation, training, and regulatory updates. The index provides high-level descriptions and intended purpose for each topic and guides the reader to the relevant page numbers for more detailed information.
cGMP as per shedule M outlines the Good Manufacturing Practices that must be followed for pharmaceutical manufacturing according to the Drugs and Cosmetics Act of India. It covers requirements for facilities, equipment, personnel, sanitation, documentation, quality control, packaging and labeling. All aspects of production from raw materials to finished products must meet GMP standards to ensure consistency and quality of manufactured drugs. Detailed written procedures and records are required for all manufacturing processes.
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
The document discusses medical device regulations from various agencies like the FDA and EU, which classify devices based on risk into Classes I to III. It also covers quality management systems like ISO 13485 that are important for product development and design controls. The key elements of design control as required by regulatory agencies are also summarized, including design planning, input, output, review, verification, and validation.
The document discusses good manufacturing practices (GMP) for pharmaceutical products. It provides background on regulatory requirements for GMP internationally and outlines key aspects of GMP documentation and records management. Effective documentation is important for ensuring quality, traceability of activities, and compliance with GMP regulations.
A primary mission of the Food and Drug Administration is to conduct comprehensive regulatory coverage of all aspects of production and distribution of drugs and drug products to assure that such products meet the 501(a)(2)(B) requirements of the Act. FDA has developed two basic strategies:
. 1) evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested and held, and
. 2) monitoring the quality of drugs and drug products through surveillance activities such as sampling and analyzing products in distribution.
FDA compliance program “ Drug Manufacturing Inpsections” (7356.002) is designed to provide guidance for implementing the first strategy. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control.
The inspectional guidance in this program is structured to provide for efficient use of resources devoted to routine surveillance coverage, recognizing that in-depth coverage of all systems and all processes is not feasible for all firms on a biennial basis. It also provides for follow-up compliance coverage as needed.
“Drug Regulations” has prepared a summary from the compliance programme and is given below in the presentation.
The two most commonly used within microbiology are
HACCP (which originated in the food industry) and FMEA
(developed for engineering). This article explores these two
approaches, first with a description of HACCP, followed by a
description and case study of FMEA in sterility testing.
Change control is a formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might effect a validated status. The intent is to determine the need for the action that would ensure that the system is maintained in a validated state.
The document discusses the validation of water supply systems for pharmaceutical use. It outlines the validation process, which includes design qualification to verify the system design, installation qualification to confirm proper installation, operation qualification to test system functionality under static conditions, and performance qualification to demonstrate consistent performance over time under normal operating conditions. Routine monitoring, maintenance, and change control procedures are also required to ensure continued system operation and water quality as specified.
This presentation discusses pre-use post-sterilization integrity testing (PUPSIT) of sterile filters. It provides background on regulatory guidance for integrity testing critical filters before and after use. Masking studies were conducted where flawed filters were exposed to blocking solutions, and in some cases the flaws were able to mask and pass post-use integrity testing. The risk of masking was found to be highly dependent on process conditions like blocking rate and solution concentration. The presentation discusses considerations for final filtration assembly design to enable PUPSIT like using redundant filters and multi-purpose ports. It addresses challenges with maintaining sterility and pressure during PUPSIT.
Statistical process control (SPC) techniques apply statistical methods to measure and analyze variation in manufacturing processes. SPC uses control charts to distinguish between common cause variation inherent to the process and special cause variation that can be assigned to a specific reason. Control charts monitor process data over time against statistical control limits. Process capability analysis compares process variation to product specifications to determine if the process is capable of meeting specifications. Key metrics like Cp, Cpk and Cpm indices quantify a process's capability relative to the specifications. For a process to have a valid capability analysis, it must meet assumptions of statistical control, normality, sufficient representative data, and independence of measurements.
This document outlines procedures for handling deviations from standard operating procedures in a cGMP environment. It defines deviations as planned or unplanned activities that differ from specified procedures. Planned deviations are deliberate temporary changes that don't affect quality, while unplanned deviations result from failures or errors. The procedures describe rules for documenting deviations, evaluating their quality impact, approving corrective actions, and filing reports. Deviations are assigned a control number and approved by quality assurance to ensure proper handling. Repeated deviations must be investigated and corrective actions taken to prevent reoccurrences.
This document provides instructions for reporting, investigating, and handling deviations from standard operating procedures and processes. It defines deviations as planned or unplanned and categorizes them based on their severity and impact on product quality. The procedure outlines the process for reporting deviations, investigating the root cause, implementing corrective and preventive actions, evaluating their effectiveness, and trending analysis. Quality assurance is responsible for approving deviation reports and deciding if batches can be released.
The document discusses six quality assurance systems for pharmaceutical manufacturers: quality management systems, production systems, facilities and equipment systems, materials management and quality control systems, documents and records systems, and management review and quality planning systems. It provides details on each system's objectives, requirements, and goals to ensure compliance with cGMP regulations. The production system section specifies requirements for batch tracking, process validation, verification of critical steps, and review of batch records. The facilities and equipment system outlines areas for separate clean and dirty operations and standards for building materials, air handling, and temperature control.
Qualification of membrane filtration apparatusPRAVADA
This document discusses the validation of membrane filtration processes. It defines qualification as ensuring equipment is properly installed and works as expected. There are four types of qualification: design, installation, operational, and performance. Membrane filtration separates solids from liquids using a porous membrane. Validation of membrane filters includes testing reproducibility, sterilization, integrity, operating conditions, inertness, antimicrobial activity, endotoxins, and toxicity to ensure the filter performs as intended. Regular performance qualification is important to check the filter maintains consistent performance over time.
This document discusses process validation. It defines process validation as establishing documented evidence that a process will consistently produce a product meeting its predetermined specifications. The key aspects of process validation are to obtain consistent and reliable data, demonstrate that the process remains in control, and show the process works as intended. There are different types of process validation including prospective, retrospective, and concurrent validation. Process validation involves multiple phases from process design and qualification to process verification and monitoring. It is important for quality, safety, efficacy and compliance with global regulatory agencies.
The document outlines various quality management topics and provides an index with page numbers for each topic. Some of the key topics covered include: site master file, validation master plan, quality manual, change control, deviation, market complaint, product recall, CAPA, process validation, stability studies, analytical method validation, training, and regulatory updates. The index provides high-level descriptions and intended purpose for each topic and guides the reader to the relevant page numbers for more detailed information.
cGMP as per shedule M outlines the Good Manufacturing Practices that must be followed for pharmaceutical manufacturing according to the Drugs and Cosmetics Act of India. It covers requirements for facilities, equipment, personnel, sanitation, documentation, quality control, packaging and labeling. All aspects of production from raw materials to finished products must meet GMP standards to ensure consistency and quality of manufactured drugs. Detailed written procedures and records are required for all manufacturing processes.
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
The document discusses medical device regulations from various agencies like the FDA and EU, which classify devices based on risk into Classes I to III. It also covers quality management systems like ISO 13485 that are important for product development and design controls. The key elements of design control as required by regulatory agencies are also summarized, including design planning, input, output, review, verification, and validation.
The document discusses good manufacturing practices (GMP) for pharmaceutical products. It provides background on regulatory requirements for GMP internationally and outlines key aspects of GMP documentation and records management. Effective documentation is important for ensuring quality, traceability of activities, and compliance with GMP regulations.
The document discusses pharmaceutical validation, including its history, purpose, and key aspects. It provides definitions for validation, describing it as demonstrating and documenting that a process will consistently produce the expected results. The summary is as follows:
Validation aims to ensure quality is built into pharmaceutical systems and processes at every step. It includes qualification of equipment and facilities. Key parts of validation include process design, qualification, and continued verification to maintain process control. Validation is required by regulations and improves quality, efficiency and compliance for the pharmaceutical industry.
Quality management Policy in PharmaceuticalPinki Devi
Quality management Policy is a set of the rule that is helpful to produce quality product at manufacturing site. 1. Background
The following document provides general considerations with respect to
Quality Assurance and Quality Management Systems and an overview of
the Audit procedures in place.
2. Responsibilities.
QA, QC, QMS and audit are the responsibility of the director of the
biorepository and its management committee.
3. Quality Assurance (QA)
This term describes an integrated system of management activities
involving planning, implementation, documentation, assessment, and
improvement to ensure that a process, or item, is of the type and
quality needed for the project. The QA systems in place will be covered
in general by ‘standard operating procedures’ (SOP) and will be made up
of the following essential components:
Title – Each SOP should be given a unique name which captures
the essence of the practice described.
Number – Each SOP should be given a unique number that can
be used for easy reference. The numbering system should
include the revision number for the practice so that the most
recent version can be easily identified.
Date – The date the procedure is to be reviewed as well as the
date of the most recent version. The date format should be
based on the ddmmyyyy system where d represents day, m
represents month and y represents year.
Protective Wear – Protective equipment that should be worn by
staff when performing the procedure described.
Equipment – A list of the equipment needed to perform the
procedure.
Supplies – All materials and supplies should be recorded.
Step-by-Step Guidance – The procedure should be written in
specific detail to ensure that the procedure can be repeated in a
reproducible fashion to include the order of steps that should be
followed, the times allowed for each step (as needed) and the
temperatures at which the steps are performed.
All SOPs before implementation or after revision will be approved by the
management committee before implementation. Previous versions of all
documentation will be stored electronically, with only the current
versions available in the biorepository file.
All SOPs will be reviewed on an annual basis by the management
committee.
QA & QM procedures
Document Reference:
Page 3 of 3
4. QUALITY MANAGEMENT SYSTEM (QMS)
The QMS describes the biorepository’s commitment to quality and
approaches for ensuring that the requirements of the QA program are
met.
Security
The facility is in a secure, locked area with limited access.
Records are maintained of all access to the facility, detailing name,
date & time and reason for entry.
Training
Personnel should be trained in all procedures and successful
completion of such training is documented with evidence of updates
as required, on a periodic basis.
Equipment. for more details you may visit https://pharmaguddu.com/
Six system inspection model pharmaceutical D-Astar.pptxDevaPundkar
The document discusses the Six System Inspection Model which can help pharmaceutical manufacturers follow CGMP guidelines. The six systems are: quality management, facility and equipment, laboratory controls, materials, packaging and labeling, and change management. Each system ensures different aspects of compliance such as quality planning, production processes, equipment qualification, testing, materials control, and packaging and labeling validation. Self-inspection and change control are also important concepts that are reviewed.
Quality assurance and quality control are important concepts in pharmaceutical manufacturing. Quality assurance refers to planned and systematic activities that ensure quality in processes, while quality control refers to activities that ensure quality in products. Some key differences are that quality assurance focuses on preventing defects through proper processes, while quality control identifies defects in finished products. Total quality management aims to produce perfect products through quality measures at every stage of production and requires team effort across an organization.
This document discusses the validation of raw materials used in pharmaceutical manufacturing. It defines validation as demonstrating through documented evidence that a process will consistently produce a product meeting predetermined specifications. The document outlines a 7 step process for validating raw materials: 1) List all raw materials needed, 2) Identify at least two suppliers for each material, 3) Qualify new suppliers by inspecting facilities, 4) Obtain supplier certificates of analysis and samples, 5) Establish specifications for each material, 6) Establish test procedures, 7) Establish sampling procedures. The validation process confirms raw materials meet specifications and ensures uniform, high quality batches.
This document discusses process validation, which establishes documented evidence that a process will consistently produce a product meeting predetermined specifications and quality attributes. It defines process validation according to various regulatory bodies and experts. The key aspects of process validation include conducting studies using larger sample sizes and more frequent testing of at least three successive batches to demonstrate the process is reproducible. Validation responsibilities, checklists, protocols, phases, reports, revalidation triggers, and focus areas during inspections are outlined.
Validation is the process of establishing documented evidence that a process, procedure, or system will consistently produce a result meeting predetermined specifications. It was first proposed in the 1970s in response to issues with sterility in pharmaceutical products. Validation applies to equipment, utilities, analytical methods, packaging materials, cleaning processes, and manufacturing processes. It helps ensure quality, reduce costs and failures, and comply with regulations. The scope of validation is broad and includes equipment qualification, process and cleaning validation, and continued verification. It requires defined processes, documentation, trained personnel, and management oversight to ensure product quality.
This publication is about HACCP documentation kit that describes list of various documents which cover requirements of HACCP Documentation. HACCP is a tool to assess hazards and establish control systems that focus on prevention
good manufacturing practices presentationUltratech4
This document discusses Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). It defines GMP as ensuring quality standards in drug production and outlines its main principles, including organization, facilities, equipment, materials control, production processes, packaging, and records. SOPs are defined as written instructions for routine tasks and the document discusses benefits like consistent performance, quality assurance, and training. A typical SOP structure is also outlined.
The document discusses documentation processes in organizations. It explains that documentation involves systematically recording people, events, and documents to create organizational records. Documentation provides information on how to complete tasks as well as evidence that tasks were done correctly. Master formula records (MFRs) are important documentation that contain all information about a pharmaceutical product's manufacturing process. MFRs are prepared by research teams and used as a reference for batch manufacturing records. The document outlines the key components that should be included in MFRs and batch manufacturing records to ensure consistency in manufacturing batches. It also discusses standard operating procedures and importance of documentation policies in organizations.
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.
Industrial Bioprocessing Simulation and Modelling
The document discusses industrial bioprocessing, simulation, and modeling. It provides an overview of bioprocessing history and applications. Process simulation and modeling tools are used to optimize efficiency without extensive experimentation. Downstream processing aims to purify products through techniques like filtration. Process design considers product properties and impurities. Scale-up requires maintaining parameters like bed height and velocity. Career opportunities exist in engineering and science roles in biopharmaceutical industries, with salary packages ranging from 3.25-8 LPA depending on level.
These ready to use LIMS are designed for versatility, security, accessibility ensuring any time connectivity over
a secure web network interface, cross platform and cross database compatibility with customization
possibilities. Well established research organizations and laboratories choose to implement enterprise edition
of LIMS after a lot of deliberation and for a bunch of good reasons
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.
Validation ( process validation, TT from R&D to pilot plant)RushikeshPalkar1
The document discusses process validation in the pharmaceutical industry. It begins by defining process validation as establishing evidence through documentation that a process is capable of consistently producing a product meeting predetermined specifications and quality attributes. It then describes the three stages of process validation: process design, process qualification, and continued process verification. The document provides details about each stage and emphasizes that process validation is important for assuring pharmaceutical product quality since end product testing alone is not sufficient. It concludes by stating that if each step of production is validated, the final product quality can be assured.
The latest version of BRC Food Issue 8 published on August, 2018 and transition from the previous version is ahead. One of the most important steps in the transition process, as well as in the initial implementation, is determining what documents are needed for an effective Food Safety System based on BRC Food Issue 8. This publication designed to understand mandatory BRC documents requirements as per latest standard BRC Food Safety Issue 8.
For more details visit our website: https://www.globalmanagergroup.com/
Quality & compliance excellence in pharmaceuticalsAnvita Bharati
Quality can be defined in several ways including conformance to specifications, fitness for use, and value for price paid. It is judged based on factors like performance, reliability, and support services provided. Pharmaceutical products have higher quality standards and more regulations compared to consumer goods due to their intended use and potential risks. Ensuring compliance with various quality guidelines is important for patient safety and involves establishing quality systems, policies, procedures, documentation, and ongoing assessments like audits and corrective actions. Non-compliance can result in issues like complaints, recalls, and regulatory actions.
1) The document provides a 10 step guide for completing a HACCP plan, including defining the scope of the plan, creating a process flow diagram, identifying control points and critical limits, establishing monitoring procedures, and documenting the plan, policies, and records.
2) Key steps include identifying food safety hazards at each process step, determining critical control points (CCPs) where legal limits apply, setting critical limits for each CCP, and establishing monitoring and corrective actions for CCPs.
3) Documentation is important for providing evidence that food safety hazards are being properly managed, and includes the HACCP plan, policies, and monitoring records like temperature readings and audit reports.
1. Quality Documentation System
This Quality system has been developed for the GMP Bioprocessing Training and Production facility on
UCC campus by Patrick O’Flynn as part of his MSc in Biotechnology project.
Figure 1 - Overall view
The system is divided into 5 folders as can be seen in Figure 1. The documentation contained within each of
these is outlined in the following pages. The aim of the system is to aid in the efficient organisation and
administration of operations at the GMP Bioprocessing Training and Production facility. It has been devised
from WHO guidelines on GMP documentation.
The basic principal is that every operation or action in the facility has a Standard Operating Procedure (SOP)
and a corresponding Data Record Form (DRF) where appropriate. A simple example is an Equipment
Operating Procedure (EOP) and the corresponding LUMAC Logbook for that piece of equipment. A
document numbering system is used for each category of document to keep track of all approved documents.
The system has been generated in an electronic format but it will be applied to the process in a hard copy
format. All documentation will have to be printed and approved prior to their application. Master copies of
SOPs will be printed on white paper and filed in the main office. Draft Copies will also be printed on white
paper but will be rubber stamped to signify their draft status. Copies of SOPs must be approved and signed
for prior to distribution. These will be printed on green paper and must be returned to the main office when
no longer needed or if the master copy undergoes a revision. These copies must then be destroyed for
security and privacy purposes. See the Directories and Document Control subfolder of the Quality
Assurance Folder for details.
The major document of the facility is the Validation Master Plan (VMP). This outlines all validation
operations in the facility and gives a strong indication of the general attitude towards quality. During
inspections, a facility’s VMP is often seen as a representative document for the quality system in place and
is the most heavily scrutinised for this reason. The VMP is to be kept in the main office and filed in the
Validation and Change Control subfolder of the Quality Assurance folder.
Documentation for GMP facility
Facility Equipment Production
Quality
Control
Quality
Assurance
2. Figure 2 - Focus on Facility
The Facility Folder is designed to hold all documentation pertaining to the facility itself (building and
utilities). This is visually illustrated in Figure 2. Note the sub-folders. The contamination control plan and all
its procedures and data record forms will be documented here.
The “Systems” folder holds all SOPs regarding the Operation, Maintenance and Calibration of utilities in the
facility. This includes procedures regarding the HVAC system and purified water loop as well as aseptic
sampling of process equipment such as a the Bioreactor.
The “Cleaning of Facility”, “Disinfection, Fumigation”, “Environment Monitoring” and “Pest Control”
folders hold SOPs, DRFs and Logbooks regarding each of their relevant topics.
The “Flow Plans” folder contains details for the flow of product, supplies, staff and waste disposal. This
includes flow plans and diagrams. See the Validation Master Plan for details regarding these activities too.
The “Cleaning and Sterilisation” folder contains SOPs for the cleaning and sterilisation of materials that will
come in direct contact with the product. These materials must be more stringently cleaned and maintained as
their direct contact with the product has a direct impact on product quality.
The “Access Control and Hygiene” folder contains a number of SOPs outlining activities such as Access
Control, Hygiene, Gowning, Degowning, Material Transfer and Personnel Conduct.
Documentation for GMP facility
Facility
Systems
Operation,
Maintenance,
Calibration
Cleaningof
Facility
SOPs, DRFs
andLogs
Disinfectant,
Fumigation
SOPs, DRFs
andLogs
Environmental
Monitoring
SOPs, DRFs
andLogs
Pest Control
SOPs, DRFs
andLogs
Flow plans
Product,
Supply,
Staff,
Waste and
Dosposal
Cleaningand
Sterilisation
Garments,
Glassware
Access
Control,
Gowning
SOPs
Entry andExit
to
Cleanrooms
SOPs,
Posters
Equipment Production
Quality
Control
Quality
Assurance
3. Figure 3 - Focus on Equipment
The Equipment folder has been designed to hold all the documentation pertaining to the equipment in the
facility. This is visually outlined in Figure 3. Note the sub-folders and their contents. The Operation,
Maintenance and Calibration category is probably the most important as this contains the Equipment
Operating Procedures (EOPs). These will be heavily referenced throughout the system in other SOPs
requiring the use of the equipment. The LUMAC (Log of use, maintenance and cleaning) logbook system is
designed to keep track of all activities involving the operation, maintenance and cleaning of equipment.
All operation manuals, product specifications, data sheets, health and safety information for the equipment
and cleaning reagents used in their maintenance are also stored in this folder.
Documentation for GMP facility
Facility Equipment
Operation,
Maintenance and
Calibration
Equipment
Operating
Procedures
(EOPs)
Equipment Data
RecordForms
LUMAC, logs and
other DRFs.
Preparationof
Cleaning
Solutions
SOPs for cleaning
solutions
Cleaningagents
data sheets,
product infofor
cleaningagents
Equipment
monitoringand
alarms
procedures,
schedules,
parameters.
Calibration of
NIST equipment
Procedures and
Records
Operation
Manuals
Maunals, product
info etc.
Production Quality Control Quality Assurance
4. Figure 4 - Focus on Production
The production folder has been designed to hold all documentation directly pertaining to production
operations. This is visually outlined in Figure 4. Note the sub-folders and their contents. The Master
Formulae (MF) folder is probably the most important here. It contains a SOP for the writing, approval,
distribution and utilisation of the MF and Batch Processing Records as well as a template for an MF. This
has been designed so that a fresh MF plan can be set up with each new client while still using the same
template each time. This gives uniformity and flexibility to the process.
The other folders contain documents pertaining to specific sections of the production process which can be
categorised according to each individual campaign and client. The Biological Starting Materials folder is
most important here as this holds the records for all biological materials (bacteria, fungi, cells, viruses etc.)
used in production processes in the facility. This record must be well-maintained.
Documentation for GMP
facility
Facility Equipment Production
Master Formulae
SOP, Template and
guide to MF
In-Process Tests
SOPs, DRFs for
tests
Preparationof
Process Buffers and
Solutions
SOPs, DRFs for
sol. prep.
Environmental
Sampling
SOPs, DRFs, EU
guidelines
Biological Starting
Materials
SOP for regulation.
data sheets for all
bio materials.
Raw
Materials
Specifications,
Product Codes
Supplier
Approval
Receipt and
Storage
Quarantine,
Release and
Approval.
Quality Control Quality Assurance
5. Figure 5 - Focus on Quality Control
The Quality Control folder has been designed to hold all documentation pertaining to quality control
operations. This is visually illustrated in Figure 5. Note the sub-folders and their contents. The different
operations have been broken down into categories for ease of reference and filing of results. Each sub-folder
contains SOPs and DRFs for the relevant operations therein.
The Analytical Assay folder will be heavily referenced throughout the other folders in SOPs requiring the
application of such assays for the relevant tests.
Documentation for GMP facility
Facility Equipment Production QualityControl
Product
Testingand
Release
SOPs, DRFs,
QC Data
sheets
Raw Material
Testing
SOPs, DRFs,
QC Datasheets
Analytical
Assays
SOPs, DRFs
Samples - Test
andRetention
SOPs, Coded
sample log,
Summary
Protocol of QC
results
CollectedQC
Datasheets
Stability
studies
SOPs, DRFs
Reference
Standardand
Control
Maintenance
andTesting
Recertification
of QC
equipment
Calibration
records
QC reagent
andmaterial
preparation
SOPs, DRFs
Quality Assurance
6. Figure 6 - Focus on Quality Assurance
The Quality Assurance Folder has been designed to hold all documentation pertaining to Quality Assurance
and administrative operations. This is visually illustrated in Figure 6. Note the sub-folders.
The Batch record review folder contains all documents related to reviewing the production process. This
includes batch record sheets, batch approval log and SOPs for the review of a batch process. These are
essential in ensuring the product has been produced to the pre-determined specifications. Adverse events are
documented through incident reports and suitable CAPAs (corrective action, preventive action) are initiated
in response to these.
The quarantine, release, rejection and storage of product procedures are outlined in SOPs found in the same
folder for ease of reference. In the case of storage, temperature monitoring must be maintained to avoid
deviations in storage conditions. Product Distribution, Complaints and Recall procedures and records are all
documented together for ease of reference too.
All employee records are maintained in the main office. This includes both professional (CVs) and health
records with appropriate confidentiality maintained. All training received by staff as part of their
employment in the facility is documented in the training records. The responsibilities of all staff members
are also outlined in a clear and concise manner.
The Validation and Change control folder contains the Validation Master Plan, as well as protocol and
report templates for an array of qualification and validation activities. All validation in the facility is to be
documented in this folder.
The Directories and Document Control folder contains the SOP master list as well as other similar
directories for the purpose of documentation control (Equipment tracker codes, LUMAC directory,
Validation protocol/report lists etc.).
The procedure for the preparation, authorisation and distribution of SOPs is also found here.
Documentation for GMP facility
Facility Equipment Production Quality
Control
Quality
Assurance
Batch Record
Review
Batch record
sheets,
approval log,
SOP etc.
Quarantine,
Release,
Rejection,
Storage
SOPs for each
step.
Temperature
monitor
records
Product
Distribution,
Complaints,
Recall
Procedures
andRecords
Adverse
Events
Reports
Incident
reports (SOP
andDRFs)
Employee
records
professional
(CVs) and
health records.
Trainingand
Responsibility
Training
records,
responsiblity
descriptions
Validation and
Change
Control
Protocols,
Reports,
Validation
Master Plan.
Directories,
Document
control
SOP Master
list, LUMAC
list, tracker
codes, SOP
prep. etc.
Inspection
Internal,
Contractor and
Vendor Audits
Audit SOP and
records,
7. Figure 7 - Current Hierarchy in System
The current documentation system references the hierarchy illustrated in Figure 7. Note the different
positions and their titles. Responsibilities are delegated to the titles listed here and anyone employed under
these titles must take on these responsibilities.
Where an SOP refers to the “Area Manager”, it means the relevant manager to the person in question. For
example, if a production operation is to be reported to the Area Manager then the Production Manager
should be notified.
Current SOPs reference these titles when outlining responsibilities, procedures and reporting action to be
taken during operation at the facility. This hierarchy can either be altered to suit the number of personnel in
the facility or those taking on extra responsibilities can just inherit the extra title(s).
Managing Director
Quality Assurance
Manager
QA Supervisor
QA Specialist
Quality Control
Manager
QC Supervisor
QCAnalyst
Maintenance Manager
Maintenance
Supervisor
Maintenance Engineer
Production Manager
Production Supervisor
Production
Microbiologist,
Operator