Читать книгу Laboratory Control System Operations in a GMP Environment - David M. Bliesner - Страница 14

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