Regulations & Guidances current as of :

(GMP-1) current good manufacturing practice

cGMP for Investigational New Drugs and Biologics
For Use in FDA-Regulated Clinical Trials

US code of federal regulations title 21: food and drugs
  • part 11—electronic records; electronic signatures
  • part 210—current good manufacturing practice in manufacturing, processing, packing or holding of drugs; general
  • part 211—current good manufacturing practice for finished pharmaceuticals
FDA Guidances for Industry
  • Contract Manufacturing Arrangements for Drugs: Quality Agreements
  • Part 11, Electronic Records; Electronic Signatures—Scope and Application
  • pat — a framework for innovative pharmaceutical development, manufacturing, and quality assurance
  • q7 good manufacturing practice guidance for active pharmaceutical ingredients
  • Quality Systems Approach to Pharmaceutical cGMP Regulations
  • questions and answers on good manufacturing practices for drugs