RQAP-GMP Examination Study References
The following is a listing of suggested Quality Assurance references. This list is not all-inclusive and candidates should not limit their study to only those references listed below. Candidates are also encouraged to study all historic and current preambles in addition to the current regulations, where applicable.
US Code of Federal Regulations
21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211?toc=1)
21 CPR Part 210. Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210?toc=1)
21 CFR Part 7, Subpart C. Recalls (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7/subpart-C?toc=1)
US Food and Drug Administration
Questions and Answers on Current Good Manufacturing Practices for Drugs (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-current-good-manufacturing-practices-drugs)
Investigating Out-of Specification (OOS) Test Results for Pharmaceutical Production (https://www.fda.gov/media/158416/download)
International Conference on Harmonization (ICH)
ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
(https://www.ema.europa.eu/en/ich-q7-good-manufacturing-practice-active-pharmaceutical-ingredients-scientific-guideline)
ICH Q9 (R1) Quality Risk Management.
(https://www.ema.europa.eu/en/ich-q9-quality-risk-management-scientific-guideline)
ICH Q10 Pharmaceutical Quality System
(https://www.ema.europa.eu/en/ich-q10-pharmaceutical-quality-system-scientific-guideline)
ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
(https://www.ema.europa.eu/en/ich-q6b-specifications-test-procedures-acceptance-criteria-biotechnological-biological-products-scientific-guideline)
ICH Q8 (R2) Pharmaceutical Development
(https://www.ema.europa.eu/en/ich-q8-r2-pharmaceutical-development-scientific-guideline)