Lecture 3 Flashcards
When did Chapter 1 of the Pharmaceutical Quality System (PQS) come into operation?
31 January 2013
What are the sections of Chapter 1: Pharmaceutical Quality System?
Principle, Pharmaceutical Quality System, Art 6 of Directives, GMP for Medicinal Products, Quality Control, Product Quality Review, Quality Risk Management.
What is outlined in Section 1: Principle of Chapter 1: PQS?
It outlines key principles ensuring products are fit for intended use and compliant with Marketing or Clinical Trial Authorization through a documented Pharmaceutical Quality System incorporating GMP and Quality Risk Management.
What does Section 2: Pharmaceutical Quality System require?
It ensures product realization, lifecycle management, compliance with GMP, specified production and control operations, root cause analysis for deviations, and that products are not sold until certified by a Qualified Person.
What is Section 3: Art 6 of Directives 2003/94/EC and 91/412/EEC about?
It requires manufacturers to establish and implement an effective pharmaceutical quality assurance (QA) system.
What do Sections 4-7 of Chapter 1 cover?
They require a review of Good Manufacturing Practice for Medicinal Products, Quality Control, Product Quality Review, and Quality Risk Management
What should the Pharmaceutical Quality System (PQS) ensure in the manufacture of medicinal products?
Consistent delivery of products with appropriate quality attributes, lifecycle management, adherence to GMP in product design, and consideration of product and process monitoring for batch release.
When did Chapter 6: Quality Control come into operation?
1 October 2014
What are the sections of Chapter 6: Quality Control?
Principle, Role of the QC department, Documentation, Testing.
What does the Principle section of Chapter 6: Quality Control cover?
It involves sampling, specifications, and testing to ensure materials are not released unless their quality is deemed satisfactory.
What is the requirement for the QC Department in Chapter 6?
The QC department should be independent, under a qualified person, and responsible for establishing, validating, and implementing QC procedures.
What is the Documentation requirement in Chapter 6?
Documentation should cover specifications, sampling/testing procedures, records, testing reports, and environmental monitoring data.
What are the requirements for Testing in Chapter 6?
Testing methods must be validated, results recorded and checked, and tests must include details like material name, batch number, test results, and reagent quality.
What are the requirements for Animal Testing in Chapter 6?
Animals should be quarantined, controlled for suitability, and properly identified before use.
