Farmacy

Sep 6 2018

Pharmaceutical Press – The Orange Guide Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017

The Orange Guide Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017

MHRA (Medicines and Healthcare products Regulatory Agency)

Compiled by the Inspection, Enforcement and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK

Pharmaceutical manufacturers

  • ISBN 978 0 85711 285 9
  • Published Jan 2017
  • Paperback

• qualification of suppliers and customers

• parallel importation and parallel distribution

• temperature control and monitoring

• GMP for excipients

• guidance on revised Annex 16 of GMP

• data Integrity definitions and guidance for industry

• principles and guidelines of GMP for active substances

• principles of GDP of active substances

• setting health based exposure limits

• formalised risk assessment for ascertaining the appropriate GMP for excipients.

1. MHRA: Licensing, Inspection and Enforcement for Human Medicines

2. EU Guidance on Good Manufacturing Practice

Guidance on Manufacture and Importation

3. UK Guidance on Manufacture

4. UK Guidance on the Manufacture, Importation and Distribution of Active Substances

Legislation on Manufacture and Importation

5. EU Legislation on Manufacture and Importation

6. UK Legislation on Manufacture and Importation

7. UK Legislation on the Manufacture, Importation and Distribution of Active Substances

Guidance on Good Distribution Practice for Wholesaling, Brokering and Active Substances

8. Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)

9. Guidelines of 19 March 2015 on Principles of Good Distribution Practice of Active Substances for Medicinal Products for Human Use (2015/C 95/01)

10. UK Guidance on Wholesale Distribution Practice

11. UK Guidance on Brokering Medicines

Legislation on Wholesale Distribution and Brokering Medicines

12. EU Legislation on Wholesale Distribution and Brokering Medicines

13. UK Legislation on Wholesale Distribution

14. UK Legislation on Brokering Medicines

Appendix 1 – Human and Veterinary Medicines Authorities in Europe

Appendix 2 – Sources of Useful Information

Appendix 3 – Importation of Active Substances for Medicinal Products for Human Use

Appendix 4 – Safety Features for Medicinal Products for Human Use – Questions and Answers





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