ABSTRACT
I. Introduction ............................................................................................ 38 II. Brief History and Recent Developments ............................................ 38
III. The Change to Mutual Recognition Agreements.............................. 39 IV. How the Change to MRAs Could Affect You.................................... 39 V. Future Changes — The Increasing Scope of GMP............................ 39
VI. Notification Procedures, Forms and Documents .............................. 40 A. MAs.................................................................................................... 40 B. Types of MA Variation .................................................................... 40
VII. Transmissible Spongiform Encephalopathy (TSE) and Regulatory Controls .............................................................................. 40
VIII. Manufacturer’s Licenses ....................................................................... 41 A. Changes Affecting MLs................................................................... 42 B. How Changes Affect MLs .............................................................. 42 C. Site Master Files (SMFs) ................................................................. 42
IX. Validation, Revalidation and All That Is Entailed ............................ 43 A. New Equipment ............................................................................... 43 B. Changes to Sterile Areas ................................................................. 43 C. Changes to Process Cleaning and Sterilizing Systems............... 44 D. Changes to Computer Systems...................................................... 44
X. Maintaining Compliance and Auditing.............................................. 45 A. Compliance and the Qualified Person.......................................... 45
1. Controlling Compliance..................................................... 45 2. QP Responsibilities .................................................................... 46
B. The Audit Process in Relation to the Change Control System ............................................................................................... 46 1. Corporate Audits........................................................................ 46 2. Customer and Supplier Audits ................................................ 47 3. Self Audits ................................................................................... 47
4. Quality System Audits .............................................................. 47 5. GMP Audits ................................................................................ 47
References.......................................................................................................... 49
The European Union (EU) is a dynamic expanding array of nationalities, cultures and histories, and progress has been made toward pan-European legislation and control for medicinal products. Expansion of the EU will continue for the foreseeable future, and differences in interpretation and application of legislation will undoubtedly continue between member states. This chapter was written from the author’s perspective as a good manufacturing practice (GMP) inspector in the U.K. It covers inspection and validation issues and touches upon marketing authorization (MA) issues. This edition contains additional information on recent controls relating to Transmissible Spongiform Encephalopathy (TSE) risks and additional controls relating to purchasing and formulation.
