The principle directive for human Good Manufacturing Practice is Directive 2003 94 EC. This is a legal requirement that must be incorporated into National Law by European Union Member States. The Directive must be followed by pharmaceutical manufacturing sites holding a Manufacturing Authorisation. The Directive has a series of Articles within it. The first few are administrative covering Scope (Article 1) and Definitions (Article 2). The next three articles are important for establishing the principles of GMP.
Article 3 covers Inspection. This means that a site with a manufacturing authorisation will be inspected to EU GMP.
Article 4 covers Conformity with GMP. This makes it a legal requirement that the site works to EU GMP.
Article 5 covers Compliance with Marketing Authorisation. This makes it a legal requirement that products are made according to their licence.
The remaining articles are the principle articles of GMP. These are listed below. They normally are short sentences of requirements. Their requirements are law.
Article 6 covers Quality Assurance
Article 7 covers Personnel
Article 8 covers Premises & Equipment
Article 9 covers Documentation
Article 10 covers Production
Article 11 covers Quality Control
Article 12 covers Contracting out
Article 13 covers Complaints, recall and emergency unblinding (during clinical trials)
Article 14 covers Self Inspection (internal audit)
Article 15 covers Labelling of Investigational Medicinal Products
All of these Articles (which are MUSTS) then link to corresponding Chapters in the Guide to GMP. Here pages of guidance is provided on how the articles can be achieved. You will see that Article 6 is the same title as Chapter 1, Article 7 the same as Chapter 2 and so on. The only exception is Article 15, which has no Chapter (but does have an Annex 13)
Chapter 1 covers Quality Assurance
Chapter 2 covers Personnel
Chapter 3 covers Premises & Equipment
Chapter 4 covers Documentation
Chapter 5 covers Production
Chapter 6 covers Quality Control
Chapter 7 covers Contracting out
Chapter 8 covers Complaints & recall
Chapter 9 covers Self Inspection (internal audit)
After the 9 Chapters comes a series of Annexes – additional GMP requirements for certain types of products and situations. These are listed below. Organisations work to these as relevant.
Annex 1. Sterile manufacturing.
Annex 2. Biological products
Annex 3. Radiopharmaceuticals
Annex 4. Veterinary medicinal products
Annex 5. Immunological veterinary products
Annex 6. Medicinal gases
Annex 7. Herbal medicinal products
Annex 8. Sampling of starting materials
Annex 9. Liquids, creams & ointments
Annex 10. Metered dose inhalers
Annex 11. Computerised systems
Annex 12. Use of ionizing radiation
Annex 13. Investigational medicinal products
Annex 14. Products derived from human blood
Annex 15.Qualification & validation
Annex 16.Certification by a Qualified Person
Annex 17. Parametric release
Annex 19. Reference samples
Annex 20. Quality Risk Management
Annex 21. Quality Management (due in 2012)
Hopefully this explains how GMP works. One final quote is from the Introduction to GMP stated below. This reminds readers that GMP is a guide and there are options to do things differently.
“It is recognised that there are acceptable methods, other than those described in the Guide, which are capable of achieving the principles of Quality Assurance. The guide is not intended to place any restraint upon the development of any new concepts or technologies which have been validated and which provide a level of Quality Assurance at least equivalent to those set out in this guide”
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NOTE – UPDATE 28th March 2012. Also see later blog article on New Structure to EU GMP.