Guideline Knowledge Base

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/good-manufacturing-practice-gmp-good-distribution-practice-gdp-inspectors-working-group).

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/good-manufacturing-practice-gmp-good-distribution-practice-gdp-inspectors-working-group).

Sets the criteria under which the FDA considers electronic records, electronic signatures and handwritten signatures executed to electronic records to be trustworthy, reliable and equivalent to paper records. Covers controls for closed and open systems, signature manifestations and record linking, and electronic signature components, controls and identification codes.

The FDA's core CGMP regulation for finished pharmaceuticals, covering organisation and personnel, buildings and facilities, equipment, control of components, production and process controls, packaging and labelling, holding and distribution, laboratory controls, records and reports, and returned and salvaged drug products. Amended by 89 FR 51769 (18 June 2024, effective 18 December 2025) to exclude medical gases.

Establishes the status and applicability of the FDA's current good manufacturing practice regulations for drugs, and the definitions used throughout parts 211, 213, 225 and 226. Amended by 89 FR 51769 (18 June 2024, effective 18 December 2025) to add part 213 for medical gases.

Imported from European Medicines Agency (https://www.ema.europa.eu/en/scientific-guidelines.xml).

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products).

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).