Health Canada · GMP
Health Canada GMP 가이드
캐나다 보건부(Health Canada)가 공개한 GMP 가이드(GUI 시리즈) 문서를 발행일 순으로 정리했습니다. 의약품 GMP 실사와 시설 허가(Establishment Licence) 운영의 기준이 되는 문서들입니다. 법적 효력과 최신본은 반드시 공식 원문에서 확인하세요.
- GUI-0005 Explanatory notes for drug establishments on the preparation of a site master file
- GUI-0031 Good manufacturing practices for medical gases
- GUI-0158 Good manufacturing practices guide for natural health products
- GUI-0080 How to demonstrate foreign building compliance with drug good manufacturing practices
- GUI-0039 Drug, natural health product and biocide recall guide
- GUI-0127 Applications and service standards for drug establishment licences
- GUI-0012 Guidance Document Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines - Veterinary Drugs
- GUI-0026 Annex 3A to the Good manufacturing practices guide - Schedule C drugs
- GUI-0027 Annex 2 to the Good manufacturing practices guide - Manufacture of biologics
- GUI-0066 Annex 7 to the Good manufacturing practices guide - Selected non-prescription drugs
- GUI-0119 Annex 1 to the Good manufacturing practices guide - Manufacture of sterile drugs
- GUI-0104 Good manufacturing practices guidelines for active pharmaceutical ingredients
- GUI-0028 Cleaning validation guide
- GUI-0029 Guide to validation - drugs and supporting activities
- GUI-0071 Annex 3B to the Good manufacturing practices guide - Positron-emitting radiopharmaceuticals
- GUI-0023 Risk classification guide for drug good manufacturing practices observations
- GUI-0001 Good manufacturing practices guide for drug products
- GUI-0002 Guidance on Drug Establishment Licences
- GUI-0036 Annex 13 to the Good manufacturing practices guide for drugs used in clinical trials
- GUI-0069 Guidelines for environmental control of drugs during storage and transportation