Actuele regelgeving met betrekking tot GMP en GDP.
- Introduction
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- Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
- Directive 2001/83/EC of the European Parliament and of the Council of 6 november 2001 (cons 2011)
- Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC
Commission Directive 2003/94/EC , of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in
respect of medicinal products for human use and investigational medicinal products for human use. - Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.
- Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for
veterinary medicinal products.EN NL
Part I – Basic Requirements for Medicinal Products
- Chapter 1 – Pharmaceutical Quality System (revision January 2013)
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- Chapter 2 – Personnel
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- Chapter 3 – Premise and Equipment
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- Chapter 4 – Documentation (revision June 2011)
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- Chapter 5 – Production
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- Chapter 6 – Quality Control (1 October 2014)
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- Chapter 7 – On Outsourced activities (revision January 2013)
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- Chapter 8 – Complaints and Product Recall
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- Chapter 9 – Self Inspection
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Part II – Basic Requirements for Active Substances used as Starting Materials
- Basic Requirements for Active Substances used as Starting Materials (NEW August 2014)
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Part III – GMP related documents
- Site Master File
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- Q9 Quality Risk Management
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- Q10 Note for Guidance on Pharmaceutical Quality System
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- MRA Batch Certificate
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- Template for the ‘written confirmation’ for active substances exported to the EuropeanUnion for medicinal products for human use
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- Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products
in shared facilities.EN NL
- Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing
practice for excipients of medicinal products for human use.
Annexes
- Annex 1 – Manufacture of Sterile Medicinal Products (revision November 2008)
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- Annex 2 – Manufacture of Biological active substances and Medicinal Products for Human Use (revision January 2013)
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- Annex 3 – Manufacture of RadioPharmaceuticals (September 2008)
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- Annex 4 – Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
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- Annex 5 – Manufacture of Immunological Veterinary Medicinal Products
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- Annex 6 – Manufacture of Medicinal Gases (February 2010)
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- Annex 7 – Manufacture of Herbal Medicinal Products (September 2008)
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- Annex 8 – Sampling of Starting and Packaging Materials
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- Annex 9 – Manufacture of Liquids, Creams and Ointments
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- Annex 10 – Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
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- Annex 11 – Computerised Systems (revision January 2011)
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- Annex 12 – Use of Ionising Radiation in the Manufacture of Medicinal Products
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- Annex 13 – Manufacture of Investigational Medicinal Products (February 2010)
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- Annex 14 – Manufacture of Products derived from Human Blood or Human Plasma (revision May 2011)
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- Annex 15 – Qualification and validation (October 2015)
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- Annex 16 – Certification by a Qualified person and Batch Release (October 2015)
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- Annex 17 – Parametric Release (July 2001)
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- Annex 19 – Reference and Retention Samples (December 2005)
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- Compilation of Community Procedures on Inspections and Exchange of Information updated toinclude new EU formats and procedures.
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- Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)
- Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use.