The document discusses quality management systems and the six system inspection model used by the FDA to ensure compliance with cGMP regulations. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it provides an overview and lists the relevant cGMP subparts that govern inspections of that system. The goal is to help pharmaceutical manufacturers implement quality systems to meet FDA requirements.
PIC/S is an organization that was established to harmonize and improve Good Manufacturing Practice standards among member countries. It brings together regulatory authorities and pharmaceutical quality systems to ensure uniformity. PIC/S provides guidelines for industry, inspectors, and regulatory authorities to facilitate information sharing and mutual understanding, with the goal of protecting public health by helping to ensure the quality and safety of medical products globally.
This document provides an overview of FDA regulations 21 CFR Parts 210 and 211, which establish current Good Manufacturing Practices (cGMP) for manufacturing, processing, packing, or holding of drugs.
The summary includes definitions of key terms such as batch, component, drug product, and quality control. It also summarizes some of the major requirements for facilities, equipment, components, containers and closures, organization and personnel, and production and process controls to ensure identity, strength, quality and purity of drug products. The goal of Parts 210 and 211 is to provide minimum requirements and requirements for quality systems, not prescribe specific ways to meet those requirements.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
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.
This document discusses concepts of change control, out of specifications (OOS), and out of trends (OOT) in pharmaceutical quality assurance. It defines change control as a procedure to review, verify, regulate, manage, approve and control changes made to systems or processes. OOS refers to test results that fall outside pre-defined acceptance criteria, while OOT describes results that do not follow expected trends. The document outlines procedures for investigating and managing changes, OOS, and OOT to ensure product quality and compliance with regulations.
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
An out of specification (OOS) occurs when analytical results fall outside established specification ranges. There are guidelines from organizations like MHRA, CDER, and PIC/S for handling OOS events. OOS can occur during stability studies, finished products, or raw materials due to laboratory errors, process issues, or sample homogeneity problems. Investigations follow a phased approach starting with the quality control laboratory and then involving manufacturing operations if needed. The fate of an OOS batch may include reprocessing, reworking, or destruction depending on the investigation conclusions.
This document discusses a six system inspection model for quality management in pharmaceutical manufacturing. It describes each of the six systems - quality system, production system, facilities and equipment system, laboratory control system, materials system, and packaging and labeling system. For each system, it outlines the key aspects and cites the relevant cGMP regulations. It emphasizes that the six systems are interrelated and must work together to ensure quality control and compliance with regulations. Regular self-inspections are also highlighted as an important part of pharmaceutical quality management.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
In this slide contains Investigation, reason, case study of OOS.
Presented by: K Venkatsai Preasad. (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
This guidance provides recommendations for holders of animal drug applications on reporting categories for changes to conditions established in approved applications. It describes changes to manufacturing sites, scales, equipment, specifications, and processes for synthetic drug substances and intermediates. The guidance recommends reporting categories of annual reports, supplements for changes being effected in 30 days, or prior approval supplements based on the type and potential impact of changes.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
The document provides guidelines for specifications of new drug substances and products. It discusses setting specifications based on development data and stability studies. Universal tests for drug substances include identification, assay, impurities. For products, additional tests depend on dosage form and may include dissolution, uniformity, sterility. The guidelines provide concepts for justifying specifications and periodic testing. They apply principles for biotech products, addressing characterization, analytical validation, process controls, and linking specifications to manufacturing and clinical data.
The document discusses Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Supplemental New Drug Applications (SNDAs). It provides details on the purpose and requirements of each application type, including necessary contents, guidelines, and the laws and regulations that govern the FDA drug approval process.
This document discusses vendor certification and categorization. It defines vendor certification as ensuring a vendor will meet regulatory expectations. Vendors are categorized from 1 to 4 based on risk, with category 1 being experts with minimal monitoring and category 4 being sole-source API manufacturers requiring intense monitoring. The document also outlines the vendor qualification process, including selection criteria, evaluation of production processes, and standard procedures for quality audits.
This document summarizes key points about manufacturing operations and quality control from a seminar presentation. It discusses good manufacturing practices, identity, strength, safety and purity as important factors. It also covers sanitation, standard operating procedures, mix-ups and contamination prevention, in-process quality control, packaging operations, process deviations, drug product inspection, and expiration dating. Maintaining quality is essential at all stages of the manufacturing and packaging process.
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.
Six system management.pptx in pharmaceutical industryvinitnai
This document discusses the six system inspection model used by the FDA for drug manufacturing inspections. The six systems are: 1) production, 2) facilities and equipment, 3) laboratory controls, 4) materials, 5) packaging and labeling, and 6) quality management. Each system is described in detail, outlining the objectives, components inspected, and relevant FDA regulations. The six systems are interrelated and aim to ensure quality control at each stage of the drug manufacturing process from raw materials to finished product in compliance with cGMP.
This document outlines the components of a six system quality inspection model for pharmaceutical manufacturing. It describes the six systems that should be included in a quality system: quality system, production system, facility and equipment system, laboratory control system, material control system, and packaging and labeling system. For each system, it lists the key aspects that should be inspected to ensure compliance with cGMP regulations. The goal is for this model to help manufacturers comply with cGMP requirements and implement an effective quality system.
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.
Regulatory agencies like the FDA, WHO, EU, and PIC/S have established validation guidelines and requirements for the pharmaceutical industry. Process validation is required to provide documented evidence that manufacturing processes produce consistent and quality products meeting specifications. It involves qualification of facilities, equipment, utilities, and processes. Validation studies include design qualification, installation qualification, operational qualification, and performance qualification. Regulatory guidelines cover validation of automated processes, suppliers' test results, sterilization processes, and analytical methods. A validation master plan and validation reports are required documentation.
The document discusses validation regulatory requirements from various authorities like the FDA, EU, WHO, and PIC/S. It outlines the objectives, historical background, and regulations for validation from these bodies. The three main stages of process validation are described as process design, process qualification, and continued process verification. Types of validation like prospective, concurrent, and retrospective are also defined.
Process validation and validation requirementRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Government regulation in pharmaceutical validationVaishnaviRaut6
This document provides an overview of government regulations for pharmaceutical validation from various regulatory bodies such as the US FDA, cGMP, WHO, EU, and PIC/S. It defines validation, discusses the importance of validation, and outlines the historical background that led to regulation. The key points are that validation became mandatory under cGMP regulations to ensure quality and minimize risk, and all major regulatory bodies now require validation studies to be conducted according to predefined protocols and provide documented evidence that processes will consistently produce quality products meeting specifications.
The document provides an overview of process validation for pharmaceutical manufacturing. It defines validation as establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. The objectives, types, and stages of validation are described. Key validation documentation like protocols, reports and master plans are summarized. Regulatory requirements for validation from agencies like FDA, EU, WHO and PIC/S are highlighted. The conclusion emphasizes that validation is critical for ensuring product quality and compliance.
Current good manufacturing practices and current good compounding Areej Abu Hanieh
The document discusses current good manufacturing practices (cGMP) regulations established by the FDA to ensure minimum quality standards for drug products. It covers cGMP requirements for facilities, equipment, components, production processes, packaging, labeling, quality control, audits and more. The regulations aim to help manufacturers produce safe and effective pharmaceuticals for patients.
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
This document summarizes types of validation and government regulations related to validation. It discusses four main types of validation: process validation, cleaning validation, equipment validation, and validation of analytical methods. It also outlines some key US FDA regulations related to validation from the Code of Federal Regulations including requirements for validating automated processes, suppliers' test results, manufacturing processes, and sterilization processes. The document emphasizes that government regulations like cGMP define validation as a system to consistently produce products according to quality standards and minimize risks that cannot be eliminated through final testing.
The document discusses process validation, providing definitions and requirements from various regulatory bodies. It can be summarized as:
1) Process validation is establishing evidence that a process consistently produces a product meeting specifications. It is required by regulations like cGMP to ensure product quality.
2) Major regulatory bodies like FDA, EU, WHO, and PIC/S require validation strategies like qualification of equipment and facilities, monitoring of critical process parameters, and verification of the production process.
3) A validation master plan and protocols are developed to guide validation activities. Validation reports document the results and conclusion of validating a manufacturing process.
Current Good Manufacturing Practices (cgmp)surajkumar1499
The document discusses cGMP (current Good Manufacturing Practices) according to the US FDA. It states that cGMP ensures quality is built into the manufacturing process from start to finish in order to minimize risks and protect product quality. It covers all aspects of manufacturing including facilities & equipment, documentation, personnel training, production & process controls, packaging & labeling, laboratory testing, and distribution. The key goal of cGMP is to assure the identity, strength, purity and quality of drugs. Compliance is required by the FDA regulations under 21 CFR Parts 210, 211, 820 etc.
The document discusses GMP compliance audits. It defines GMP audits as a process to verify that manufacturers follow good manufacturing practices regulations. There are two types of audits - onsite audits, which involve visiting the production site, and desktop audits, which review documentation without a site visit. Audits check various aspects of production including personnel, facilities, equipment, processes, warehousing and more. They help identify issues, ensure proper controls, and improve compliance.
Quality Control and Quality Assurance in Pharmaceuticals.pptxShraddhaJadhav80
This document provides an overview of quality control and quality assurance in the pharmaceutical industry. It discusses key concepts like quality control, quality assurance, good manufacturing practices, good laboratory practices, in-process quality control, regulatory authorities, validation, and quality by design. Quality control ensures pharmaceutical products meet defined standards through testing, while quality assurance monitors the manufacturing process to ensure compliance with regulations and specifications. Together, quality control and quality assurance aim to deliver standardized, contamination-free pharmaceutical products.
c gmp (current good manufacturing practices)Rohit K.
cGMP (Current Good Manufacturing Practices) regulations provide the framework for ensuring quality control during pharmaceutical manufacturing. The regulations are divided into parts 210 and 211. Part 211 addresses good manufacturing practices for finished pharmaceuticals and is further divided into 11 subparts covering organization, facilities, equipment, production, packaging, labeling, quality control, and more. The goal of cGMP is to ensure identity, strength, quality and purity of drugs through strict control of manufacturing and monitoring.
FDA conducts inspections of drug manufacturing facilities to ensure compliance with cGMP regulations. The inspection process involves:
1) Pre-inspection notification and document requests sent to manufacturers in advance.
2) Onsite inspections of multiple quality systems including facilities, materials, production, packaging and labeling, and laboratories.
3) Closing meeting where inspectors present any observation on cGMP deficiencies.
4) Post-inspection reports are filed classifying inspection results and recommending any further compliance actions if needed. The goal is to minimize risks of adulterated drugs reaching consumers.
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(𝐓𝐋𝐄 𝟏𝟎𝟎) (𝐋𝐞𝐬𝐬𝐨𝐧 𝟏.𝟎)-𝐅𝐢𝐧𝐚𝐥𝐬
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-Students will understand the basics of gardening, including the importance of soil, water, and sunlight for plant growth. They will learn to identify and use essential gardening tools, plant seeds, and seedlings properly, and manage common garden pests using eco-friendly methods.
Beyond the Advance Presentation for By the Book 9John Rodzvilla
In June 2020, L.L. McKinney, a Black author of young adult novels, began the #publishingpaidme hashtag to create a discussion on how the publishing industry treats Black authors: “what they’re paid. What the marketing is. How the books are treated. How one Black book not reaching its parameters casts a shadow on all Black books and all Black authors, and that’s not the same for our white counterparts.” (Grady 2020) McKinney’s call resulted in an online discussion across 65,000 tweets between authors of all races and the creation of a Google spreadsheet that collected information on over 2,000 titles.
While the conversation was originally meant to discuss the ethical value of book publishing, it became an economic assessment by authors of how publishers treated authors of color and women authors without a full analysis of the data collected. This paper would present the data collected from relevant tweets and the Google database to show not only the range of advances among participating authors split out by their race, gender, sexual orientation and the genre of their work, but also the publishers’ treatment of their titles in terms of deal announcements and pre-pub attention in industry publications. The paper is based on a multi-year project of cleaning and evaluating the collected data to assess what it reveals about the habits and strategies of American publishers in acquiring and promoting titles from a diverse group of authors across the literary, non-fiction, children’s, mystery, romance, and SFF genres.
Lecture_Notes_Unit4_Chapter_8_9_10_RDBMS for the students affiliated by alaga...Murugan Solaiyappan
Title: Relational Database Management System Concepts(RDBMS)
Description:
Welcome to the comprehensive guide on Relational Database Management System (RDBMS) concepts, tailored for final year B.Sc. Computer Science students affiliated with Alagappa University. This document covers fundamental principles and advanced topics in RDBMS, offering a structured approach to understanding databases in the context of modern computing. PDF content is prepared from the text book Learn Oracle 8I by JOSE A RAMALHO.
Key Topics Covered:
Main Topic : DATA INTEGRITY, CREATING AND MAINTAINING A TABLE AND INDEX
Sub-Topic :
Data Integrity,Types of Integrity, Integrity Constraints, Primary Key, Foreign key, unique key, self referential integrity,
creating and maintain a table, Modifying a table, alter a table, Deleting a table
Create an Index, Alter Index, Drop Index, Function based index, obtaining information about index, Difference between ROWID and ROWNUM
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Final year B.Sc. Computer Science students at Alagappa University seeking a solid foundation in RDBMS principles for academic and practical applications.
About the Author:
Dr. S. Murugan is Associate Professor at Alagappa Government Arts College, Karaikudi. With 23 years of teaching experience in the field of Computer Science, Dr. S. Murugan has a passion for simplifying complex concepts in database management.
Disclaimer:
This document is intended for educational purposes only. The content presented here reflects the author’s understanding in the field of RDBMS as of 2024.
Feedback and Contact Information:
Your feedback is valuable! For any queries or suggestions, please contact muruganjit@agacollege.in
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No, it's not a robot: prompt writing for investigative journalism
Six system inspection model
1. Presented By :
Vaishali D. Dandge
M.Pharm, Quality Assurance, 1st Sem
Guided By :
Monika Jadhao Mam
Subject : Quality Management System
Vidya Bharti College Of Pharmacy, Amravati
June 21
VAISHALI DANDGE
3. QUALITY MANAGEMENT
SYSTEM :
A QMS is a collection of business processes focused on consistently meeting
customer requirements and enhancing their satisfaction.
It is expressed as organizational goals and aspirations, policies, processes,
documented information and resources needed to implement and maintain it.
Early QMS emphasized predictable outcomes of an industrial product
production line, using simple statistics and random sampling.
June 21
VAISHALI DANDGE
4. SIX SYSTEM INSPECTION MODEL
A model that can help pharmaceutical manufacturers comply with cGMP
regulation.
The six systems referred to in this inspection model are:
Quality System
Production System
Facilities and equipment system
Laboratory control system
Material system
Packaging and labeling system
MANUFACTURING SYSTEMS
June 21
VAISHALI DANDGE
5. The diagram shows the correlation ship amongst the six systems: the quality
system and the five manufacturing systems, which appear to be closely
interrelated and inseparable during operations.
June 21
VAISHALI DANDGE
6. INTRODUCTION
The FDA's Drug Manufacturing Inspection Compliance Program, which
contains instructions to FDA personnel for conducting inspections, is a
systems-based approach to inspection and is very consistent with the robust
quality system model presented in this guidance.
The quality system provides the foundation for the manufacturing systems
that are linked and function within it. The quality system model described in
this guidance does not consider the five manufacturing systems as discrete
entities, but instead integrates them into appropriate sections of the model.
Those familiar with the six-system inspection approach will see organizational
differences in this guidance; however, the inter-relationship should be readily
apparent.
June 21
VAISHALI DANDGE
7. One of the important themes of the systems based inspection compliance program
is that you have the ability to assess whether each of the systems is in a state of
control.
The quality system model presented in this guidance will also serve to help firms
achieve this state of control.
Pharmaceutical manufacturers should implement modern quality systems with
risk management approaches to meet the requirements of the Agency's current
good manufacturing practice (cGMP) as per regulations 21 Code of Federal
Regulations (CFR) parts 210 and 211.
June 21
VAISHALI DANDGE
8. Quality System:
This system assures overall compliance with cGMP and internal procedures
and specifications.
The system includes the quality control unit and all of its review and approval
duties (e.g., change control, reprocessing, batch release, annual record review,
validation protocols, and reports, etc.).
It includes all product defect evaluations and evaluation of returned and
salvaged drug products.
Inspection is carry out according to cGMP regulation, 21 CFR 211 Subparts B,
E, F, G, I, J, and K.
June 21
VAISHALI DANDGE
9. Subpart B - Organization and Personnel
Responsibilities of quality control unit.
Personnel qualifications.
Personnel responsibilities.
Consultants.
Subpart E - Control of Components and Drug Product Containers and
Closures
General requirements.
Receipt and storage of untested components, drug product containers, and
closures.
Testing and approval or rejection of components, drug product containers,
and closures.
Use of approved components, drug product containers, and closures.
Retesting of approved components, drug product containers, and closures.
Rejected components, drug product containers, and closures.
Drug product containers and closures.
June 21
VAISHALI DANDGE
10. Subpart F - Production and Process Controls
Written procedures; deviations.
Charge-in of components.
Calculation of yield.
Equipment identification.
Sampling and testing of in-process materials and drug products.
Time limitations on production.
Control of microbiological contamination.
Reprocessing.
Subpart G - Packaging and Labeling Control
Materials examination and usage criteria.
Labeling issuance.
Packaging and labeling operations.
Tamper-evident packaging requirements for over-the-counter (OTC) human
drug products.
Drug product inspection.
Expiration dating.
June 21
VAISHALI DANDGE
11. Subpart I - Laboratory Controls
General requirement.
Testing and release for distribution.
Stability testing.
Special testing requirements.
Reserve samples.
Laboratory animals.
Penicillin contamination.
Subpart J - Records and Reports
General requirements.
Equipment cleaning and use log.
Component, drug product container, closure, and labeling records.
Master production and control records.
Batch production and control records.
Production record review.
Laboratory records.
Distribution records.
Complaint files.
Subpart K - Returned and Salvaged Drug Products
Returned drug products.
Drug product salvaging.
June 21
VAISHALI DANDGE
12. Production System
This system includes measures and activities to control the manufacture of
drugs and drug products including
batch compounding
dosage form production
in-process sampling and testing
process validation
It also includes establishing, following, and documenting performance of
approved manufacturing procedures.
Inspection is carry out according to the cGMP regulation, 21 CFR 211
Subparts B, F, and J.
June 21
VAISHALI DANDGE
13. According to the cGMP :
Quality and manufacturing process and procedures (and changes to them) must
be defined, approved and controlled.
Batch numbering and maintaining proper traceability is required/process
validation is required.
– Track batch, equipment use records and labeling used,
personnel, raw material controls are traceable.
Verification of all steps including sign-off are required for critical process
steps.
Verification/ validation of computerized processes.
All batch records must be reviewed and have QA approval before the product
is released.
June 21
VAISHALI DANDGE
14. 21 CFR 211 Subparts B, F, and J :
Subpart F - Production and Process Controls
Written procedures; deviations.
Charge-in of components.
Calculation of yield.
Equipment identification.
Sampling and testing of in-process materials and drug products.
Time limitations on production.
Control of microbiological contamination.
Reprocessing.
June 21
VAISHALI DANDGE
15. FACILITIES AND EQUIPMENT
SYSTEM
This system includes the measures and activities which provide an appropriate
physical environment and resources used in the production of the drugs or drug
products.
It includes:
a) Buildings and facilities along with maintenance;
b) Equipment qualifications (installation and operation); equipment calibration
and preventative maintenance; and cleaning and validation of cleaning
processes as appropriate. Process performance qualification will be evaluated
as part of the inspection of the overall process validation which is done within
the system where the process is employed;
c) Utilities that are not intended to be incorporated into the product such as
HVAC, compressed gases, steam and water systems.
Inspection is carry out according to the cGMP regulation, 21 CFR 211
Subparts B, C, D, and J.
June 21
VAISHALI DANDGE
16. 21 CFR 211 Subparts B, C, D, and J:
Subpart C - Buildings and Facilities
Design and construction features.
Lighting.
Ventilation, air filtration, air heating and cooling.
Plumbing.
Sewage and refuse.
Washing and toilet facilities.
Sanitation.
Maintenance.
Subpart D – Equipment
Equipment design, size, and location.
Equipment construction.
Equipment cleaning and maintenance.
Automatic, mechanical, and electronic equipment.
Filters.
June 21
VAISHALI DANDGE
17. Laboratory Control System:
This system includes measures and activities related to
Laboratory procedures
Testing
Analytical methods development
Validation or verification
The stability program
Inspection is carry out according to the cGMP regulation, 21 CFR 211
Subparts B, I, J, and K.
June 21
VAISHALI DANDGE
18. 21 CFR 211 Subparts B, I, J, and K:
Subpart I - Laboratory Controls
General requirements.
Testing and release for distribution.
Stability testing.
Special testing requirements.
Reserve samples.
Laboratory animals.
Penicillin contamination.
Subpart K - Returned and Salvaged Drug Products
Returned drug products.
Drug product salvaging.
June 21
VAISHALI DANDGE
19. Materials System
This system includes measures and activities to control finished products,
components, including water or gases that are incorporated into the product,
containers and closures.
It includes :
validation of computerized inventory control processes,
drug storage,
distribution controls, and
records.
Inspection is carry out according to the cGMP regulation, 21 CFR 211
Subparts B, E, H, and J.
June 21
VAISHALI DANDGE
20. Component
• Any ingredient intended for use in the manufacture of a drug product,
including those that may not appear in such drug product, 21 CFR 210.3(b)(3)
• Ex. excipients, water, gases, etc., even if not in final product
Active Ingredient
• Any component that is intended to furnish pharmacological activity or other
direct effect in the diagnosis, cure, mitigation, or to affect the structure or any
function of the body of man or other animal, 21 CFR 210.3 (b)(7)
Inactive ingredient (excipient)
• Any component other than an active component, 21 CFR 210.3(b)(8)
June 21
VAISHALI DANDGE
21. 21 CFR 211 Subparts B, E, H, and J
Subpart E - Control of Components and Drug Product Containers and Closures
General requirements.
Receipt and storage of untested components, drug product containers, and
closures.
Testing and approval or rejection of components, drug product containers,
and closures.
Use of approved components, drug product containers, and closures.
Retesting of approved components, drug product containers, and closures.
Rejected components, drug product containers, and closures.
Drug product containers and closures.
Subpart H - Holding and Distribution
Warehousing procedures.
Distribution procedures
June 21
VAISHALI DANDGE
22. Packaging and
Labeling System
This system includes measures and activities that control the packaging and
labeling of drugs and drug products.
It includes
written procedures
label examination and usage
label storage and issuance
packaging and labeling operations controls
validation of these operations
Inspection is carry out according to the cGMP regulation, 21 CFR 211
Subparts B, G, and J.
June 21
VAISHALI DANDGE
23. 21 CFR 211 Subparts B, G, and J:
Subpart G - Packaging and Labeling Control
Materials examination and usage criteria.
Labeling issuance.
Packaging and labeling operations.
Tamper-evident packaging requirements for over-the-counter (OTC)
human drug products.
Drug product inspection.
Expiration dating.
June 21
VAISHALI DANDGE
24. Objectives of Inspection
1. To detect and remove the faulty raw materials before it undergoes
production.
2. To detect the faulty products in production whenever it is detected.
3. To bring facts to the notice of managers before they become serious to enable
them discover weaknesses and overcome the problem.
4. To prevent the substandard reaching the customer and reducing complaints.
5. To promote reputation for quality and reliability of product.
June 21
VAISHALI DANDGE
25. Purpose of Inspection
1. To distinguish good lots from bad lots.
2. To distinguish good pieces from bad pieces.
3. To determine if the process is changing.
4. To determine if the process is approaching the specification limits.
5. To rate quality of product.
6. To rate accuracy of inspectors.
7. To measure the precision of the measuring instrument.
8. To secure products-design information.
9. To measure process capability.
June 21
VAISHALI DANDGE