GMP FDA: which production processes should I validate?

GMP means “Good Manufacturing Practices”. The GMP requirements, defined by the US Food & Drug Administration, relate to all company’s operational aspects affecting directly or indirectly the final product quality. Therefore, not only on design and production activities, but also on all processes supporting the “Operations”. You just need to apply the quality system requirements , specified by the standards of the “Code of Federal Regulation” (CFR) Title 21 part 820. These standards are available at the following link “21 CFR 820 – GMP/QUALITY SIYSTEM REGULATION”.