GMP Audit Resources by Country

1. Health Canada — Good Manufacturing Practices Guide (GUI-0001)
2. Annex 1 to the Good manufacturing practices guide - Manufacture of sterile drugs (GUI-0119)
3. Annex 2 to the Good manufacturing practices guide - Manufacture of biologics (GUI-0027): General guidance
4. Good manufacturing practices guidelines for active pharmaceutical ingredients (GUI-0104)

National Medical Products Administration

Medical Device Manufacturing:

• Provisions for Supervision and Administration of Medical Device Manufacturing

Medical Device Distribution:

• Provisions for Supervision and Administration of Medical Device Distribution

Cosmetics:

1. Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics
2. Drug Administration Law of the People's Republic of China

1. EU GMP Annex 1: Manufacture of Sterile Medicinal Products
2. EU GMP Annex 2: Manufacture of Biological Medicinal Products for Human Use
3. EU GMP Annex 3: Manufacture of Radiopharmaceuticals
4. EU GMP Annex 6: Manufacture of Medicinal Gases
5. EU GMP Annex 7: Manufacture of Herbal Medicinal Products
6. EU GMP Annex 11: Computerized Systems
7. EU GMP Annex 14: Manufacture of Medicinal Products Derived from Human Blood or Plasma
8. EU GMP Annex 15: Qualification and Validation

Part I - Basic Requirements for Medicinal Products

• Chapter 1 - Pharmaceutical Quality System 
• Chapter 2 - Personnel 
• Chapter 3 - Premise and Equipment 
• Chapter 4 - Documentation 
• Chapter 5 - Production 
• Chapter 6 - Quality Control 
• Chapter 8 - Complaints and Product Recall 
• Chapter 9 - Self-Inspection

Part II - Basic Requirements for Active Substances used as Starting Materials

Part IV - GMP requirements for Advanced Therapy Medicinal Products

1. Central Drugs Standard Control Organization 
2. Biologicals
3. Drugs and Cosmetics Act, 1940
4. Drugs Rules, 1945
5. Medical Devices Rules, 2017
6. New Drugs and Clinical Trials Rules, 2019
7. Cosmetics Rules, 2020
8. Cosmetics
9. Medical Device & Diagnostics
10. Clinical trials & new drug
11. Guidance documents

1. PMDA 
2. Drugs 
3. New Drugs (based on the review categories）
4. Vaccines and Blood Products
5. Generic Products / Over-the-counter (OTC) Drugs/Quasi-Drugs
6. Radiopharmaceuticals
7. Biosimilars
8. Medical Devices 1 
9. Medical Devices 2
10. Quasi-drugs
11. Regenerative medical products
12. GMP compliance inspection
13. QMS 

1. National Pharmaceutical Regulatory Agency (NPRA) 
2. Regulation Basics
3. Active Pharmaceutical Ingredient (API)
4. Biologics
5. Combination Products
6. Cosmetics
7. Generic Medicine
8. Health Supplements
9. New Chemical Entity (NCE)
10. Compliance and Licensing:
11. Regulatory Control of Medicinal Gases

1. Health Sciences Authority 
2. Health products and medical device regulation
3. Therapeutic Products
4. Medical Devices
5. Health Supplements
6. Cosmetic products
7. Cell, tissue or gene therapy products
8. Chinese proprietary medicines
9. Regulatory Overview of Traditional Medicines

1. Food and Drug Administration (FDA)
2. Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
3. Combination Products Guidance Documents
4. Biologics Guidances
5. Guidance Related to Tobacco Products
6. Cosmetics Guidance Documents
7. Cellular & Gene Therapy Guidances
8. Biosimilars Guidances
9. Code of Federal Regulations (21CFR)
10. Medical Devices
11. CMC and GMP Guidances
12. Electronic Product Radiation Control Program: Industry Guidance
13. Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice

• Medicines: good manufacturing practice and good distribution practice
• Rules and Guidance for Pharmaceutical Manufacturers and Distributors
• Advanced therapy medicinal products: regulation and licensing in UK

International Conference on Harmonization (ICH)

• Quality Guidelines

WHO (World Health Organization)

• All the WHO Guidelines