GMP in Practice (File 1–3)

File 1

• Chapter 3 Premises The entire chapter “Premises” has been subject to a comprehensive revision. Official and general requirements – the former chapters 3.A and 3.B – were updated and combined in a new chapter 3.A Official Requirements (Dr. M. Hiob / R. Gomez). Chapter 3.C Room classes (formerly 3.D) was updated in order to reflect the requirements of the revised Annex 1 to the EU GMP Guide (Dr. H. Schicht). Chapter 3.F Building Services was elaborated and restructured (Dr. Th. Schreiner). As part of the revision of the chapter, several new topics were introduced as well:
• Barrier Systems and Isolators (chapter 3.E) are techniques of incremental importance with view to the increasing requirements regarding aseptic processing. Dr. Hans Schicht describes technical aspects and construction principles, discusses implementation options and decontamination techniques and defines regulatory and normative requirements.
• Chapter 3.H Process Gases (Dr. Thomas Schreiner) describes quality requirements for compressed air and other pharmaceutical gases and outlines GMP-aspects related to the generation, storage, transport and distribution systems for process gases. The chapter includes information on qualification, maintenance and monitoring of the respective systems.
• The Qualification of premises and air-conditioning systems is subject of chapter 3.I (Dr. Hans Schicht). Regulatory and normative requirements are described and their implementation in qualification plans and reports is shown by means of illustrative checklists. Beyond this, the author explains the requirements for periodical and extraordinary requalification.
• Chapter 3.J Monitoring of HVAC Systems (Dr. Hans Schicht) gives a comprehensive overview on measurement, registration and storage of data impacting safety and quality of drug products. A distinction has to be made between physical and microbiological data. Alarm- and action limits have to be defined, and data should be subject to regular trend analyses.

File 2

• Chapter 8 Cleaning Validation This chapter, which mainly focused on European and PIC/S requirements, was completely reviewed by Ralph Gomez and amended by US requirements regarding cleaning validation. The overall information was checked for up-to-dateness and amended as necessary.
• Chapter 9 Computer Validation Chapter 9.B was updated to reflect the current state of Regulatory Requirements. Provisions of the recent revision of 21CFR 211 in the context of computerized systems and the need for doublechecks by a second person are mentioned, and reference is made to the new GAMP® 5 (Dr. Peter Bosshard).
• Chapter 9.D Risk Analysis and System Classification was updated in order to reflect changes in system classification from GAMP® 4 to 5 (Dr. Peter Bosshard).
• Chapter 11 Production Within chapter 11.E Environmental monitoring, section 11.E.3.2 US requirements has to be replaced due to an editorial mistake.
• References (3.K, 8.K, 9.H. 14.M) Starting with the actual update, we will provide subchapters with compilations of topic-specific references to each of the chapters in the “GMP in Practice” part. Regulatory requirements of different regions, international guidelines and standards as well as scientific publications are clearly represented in the respective subchapters.

GMP Regulations (File 4–5)

File 4

• Chapter A Information
  Chapter A.3 Abbreviations has been reviewed and updated.
• Chapter D USA: CFR and FDA Guidelines
  Chapter D.13 was updated and provides now the recent version of 21 CFR Part 820.
  Chapter D.16 shows the table of contents of the Federal Food, Drugs, and Cosmetics Act and includes the actual web-link to this huge document.
  Chapter D.15 introduces one more FDA Guidance into the GMP MANUAL, the Guidance for Industry: CGMP for Phase 1 Investigational Drugs. This document describes the FDA’s expectations and recommendations for applying CGMP practices to the manufacture and control of investigational drugs for phase 1 clinical trials.

File 5

• Chapter E ICH Guidelines
  With the current update, chapter E.4.B ICH Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions is updated (Annex 2 and 3) and extended (Annexes 4 – 10). This chapter gives an overview on harmonized pharmacopoeial texts for use in USA, Europe and Japan.

With this update 08 we deliver to you a lot of new and revised documents which will keep the GMP MANUAL up-to-date. Take the time (approx. 20 min.) to file the pages into your GMP MANUAL.

If you have any comments, questions, references or suggestions for improvement, please do not hesitate to contact us. We will check every request in order to improve the GMP MANUAL. So that the GMP MANUAL continues to be: The most powerful GMP reference tool in the world.

Please contact: service@gmp-publishing.com