Central Drugs Standard Control Organization (CDSCO, India)
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH-International)
Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) (PIC/S-International)
There are numerous other country-specific bodies, which enforce their own laws related to the manufacturing, processing, packing, or holding of drugs. The reader is encouraged to consult the requirements of their own country's laws and regulations regarding the manufacture of pharmaceuticals.
Regulatory Guidance
Traditionally, Regulatory Agencies themselves have provided limited insight and assistance into how organizations operating within the pharmaceutical industry can comply with the regulations. However, over time, regulatory guidances and other instruments have arisen and evolved and today consist of a fairly large body of knowledge, which can be used by organizations to aid in compliance with the CGMPs.
When it comes to regulatory guidance for Quality Control (QC) Laboratories, the following documents may be helpful:
US FDA Compliance Programs to FDA staff, Chapter 56: Drug Quality Assurance 7366.002 Drug Manufacturing Inspections
US FDA Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations
ICH Harmonised Tripartite Guideline, Q1A to Q1F Stability
ICH Harmonised Tripartite Guideline, Q2 Analytical Validation
ICH Harmonised Tripartite Guideline, Q3A to Q3D Impurities
ICH Harmonised Tripartite Guideline, Q4 to Q4B Pharmacopoeias
ICH Harmonised Tripartite Guideline, Q6A to Q6B Specifications
ICH Harmonised Tripartite Guideline, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ICH Harmonised Tripartite Guideline, Q8 Pharmaceutical Development
ICH Harmonised Tripartite Guideline, Q9 Quality Risk Management
ICH Harmonised Tripartite Guideline, Q10 Pharmaceutical Quality System
ICH Harmonised Tripartite Guideline, Q12 Lifecycle Management
ICH Harmonised Tripartite Guideline, Q14 Analytical Procedure Development
WHO Annex 2: Good Manufacturing Practices for Pharmaceutical Products: Main Principles
FDA Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations, September 2006
It should be noted that although not legally binding, violation of the principals of ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7, are sometimes documented as findings by FDA.
Additional FDA and ICH guidelines exist and can be located at: https://www.fda.gov/drugs/guidances-drugs/all-guidances-drugs, https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html, and https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-compliance-programs
Application of This Text
The remainder of “Laboratory Control System Operations in a GMP Environment” is dedicated to describing the critical functions of the LCS sub elements so the reader understands what is expected from the FDA and the Global Regulatory Agencies listed earlier. In addition, each chapter will present or link to tools, templates, checklists, and some of the Global Regulatory Agencies' guidance listed previously.
It should be noted that text is written for a broad audience. It is applicable to both Quality Control and Quality Assurance professionals in small, medium, and large companies within the pharmaceutical and biopharmaceutical industries. R&D personnel working in non-GMP environments will also benefit applying the organizational schemes and principals presented in this text.1 Also, foreign firms in China and India will find this book especially useful.
This book is particularly helpful for personnel who work in smaller companies because they often do not have the financial, personnel resources, and existing “corporate knowledge” that a large US- and European-based company may have and are therefore often left to “figure it out” on their own. In this respect the guide is particularly valuable in the example-templates and checklists it includes.
Overlap and Redundancy
As the reader progresses through this text, they will notice that some topics, notes, and clarifications are addressed more than once and in different locations within the book. This was done by the author on purpose to ensure that important topics are addressed appropriately and reinforced.
Additionally, the QC laboratory is a very complex and dynamic entity, which continually grows and evolves over time. This means that the 10 sub elements into with the LCS is divided (which is purely a matter of choice on the part of the author) can be reduced, modified, or expanded to address changes within the organization and the evolution of Regulatory Agency expectations and standard industry practices. This is why there is a “C” in CGMP: C means current, which is today, not yesterday.
Tools and Templates
The following are provided in electronic format in the Chapter 1 Appendix (www.wiley.com/go/Bliesner/LabControl_GMPEnvironment):
21 Code of Federal Regulations Parts 210 and 211 – Current Good Manufacturing Practice Regulations, Revised as of April 1, 2005
US FDA Compliance Programs to FDA staff, Chapter 56: Drug Quality Assurance 7366.002 Drug Manufacturing Inspections, October 31, 2017.
US FDA Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations, September 2006.
References
1 1 21 CFR Parts 210 and 211 Current Good Manufacturing Practice for Finished Pharmaceuticals.
2 2 US FDA (2017). Compliance Programs to FDA staff, Chapter 56: Drug Quality Assurance 7356.002 Drug Manufacturing Inspections.
Note
1 1 In June 2018 the ICH Assembly endorsed ICH Q14 “Analytical Procedure Development Guideline”
