[实用参考]英文GMP培训.ppt
合集下载
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
materials Recalled products Returned goods Reagents and culture media Reference standards Waste materials Miscellaneous 15. Documentation General Documents required
Guidelines and references
GMP: World Health Organization
WHO Technical Report Series, No. 908, 2003, Annex 4. Good Manufacturing Practices for pharmaceutical products: main principles
General The contract giver The contract accepter The contract
Good Manufacturing Practices (GMP)
8. Self-inspection and quality audits Items for self-inspection Self-inspection team Frequency of self-inspection Self-inspection report Follow-up action Quality audit Suppliers’ audits and approval
pharmaceutical products (GMP) 3. Sanitation and hygiene 4. Qualification and validation 5. Complaints 6. Product recalls 7. Contract production and analysis
Good Manufacturing Practices
Dar Es Salaam, ania
August 2006 Dr AJ van Zyl
for Quality Assurance and Safety: Medicines
Medicines Policy and Standards Health Technology and Pharmaceuticals Cluster
Quality control •API, excipients •Packaging material •Data verification (e.g. stability)
Good Manufacturing Practices (GMP)
Production •Product focus •Premises •Utilities •Equipment •Dosage form and data verification (development, validation, biobatch, stability, BMR and specification) •Documentation
Good Manufacturing Practices (GMP)
13. Equipment 14. Materials
General Starting materials Packaging materials Intermediate and bulk products Finished products Rejected, recovered, reprocessed and reworked
WHO Technical Report Series, No. 917, Annex 3. Water
WHO Technical Report Series, No. 937 HVAC and others (2006)
Good Manufacturing Practices (GMP)
1. Quality assurance 2. Good manufacturing practices for
17. Good practices in quality control Control of starting materials and intermediate, bulk and finished products Test requirements Batch record review Stability studies
World Health Organization
Program
Good Manufacturing Practices
• Presentation on GMP (Production focus)
• Product specific focus • Group session
• Presentation on GMP (QC focus) • Product specific focus • Group session
Good Manufacturing Practices (GMP)
16. Good practices in production General Prevention of cross-contamination and bacterial contamination during production Processing operations Packaging operations
Good Manufacturing Practices (GMP)
Production •Utilities •Equipment •Dosage form and data verification (development, validation, biobatch, stability, BMR and specification)
9. Personnel General Key personnel
Good Manufacturing Practices (GMP)
10. Training 11. Personal hygiene 12. Premises
General Ancillary areas Storage areas Weighing areas Production areas Quality control areas
Guidelines and references
GMP: World Health Organization
WHO Technical Report Series, No. 908, 2003, Annex 4. Good Manufacturing Practices for pharmaceutical products: main principles
General The contract giver The contract accepter The contract
Good Manufacturing Practices (GMP)
8. Self-inspection and quality audits Items for self-inspection Self-inspection team Frequency of self-inspection Self-inspection report Follow-up action Quality audit Suppliers’ audits and approval
pharmaceutical products (GMP) 3. Sanitation and hygiene 4. Qualification and validation 5. Complaints 6. Product recalls 7. Contract production and analysis
Good Manufacturing Practices
Dar Es Salaam, ania
August 2006 Dr AJ van Zyl
for Quality Assurance and Safety: Medicines
Medicines Policy and Standards Health Technology and Pharmaceuticals Cluster
Quality control •API, excipients •Packaging material •Data verification (e.g. stability)
Good Manufacturing Practices (GMP)
Production •Product focus •Premises •Utilities •Equipment •Dosage form and data verification (development, validation, biobatch, stability, BMR and specification) •Documentation
Good Manufacturing Practices (GMP)
13. Equipment 14. Materials
General Starting materials Packaging materials Intermediate and bulk products Finished products Rejected, recovered, reprocessed and reworked
WHO Technical Report Series, No. 917, Annex 3. Water
WHO Technical Report Series, No. 937 HVAC and others (2006)
Good Manufacturing Practices (GMP)
1. Quality assurance 2. Good manufacturing practices for
17. Good practices in quality control Control of starting materials and intermediate, bulk and finished products Test requirements Batch record review Stability studies
World Health Organization
Program
Good Manufacturing Practices
• Presentation on GMP (Production focus)
• Product specific focus • Group session
• Presentation on GMP (QC focus) • Product specific focus • Group session
Good Manufacturing Practices (GMP)
16. Good practices in production General Prevention of cross-contamination and bacterial contamination during production Processing operations Packaging operations
Good Manufacturing Practices (GMP)
Production •Utilities •Equipment •Dosage form and data verification (development, validation, biobatch, stability, BMR and specification)
9. Personnel General Key personnel
Good Manufacturing Practices (GMP)
10. Training 11. Personal hygiene 12. Premises
General Ancillary areas Storage areas Weighing areas Production areas Quality control areas