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

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  • Directive 2001/83/EC of the European Parliament and of the Council of 6 november 2001 (cons 2011)

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  • 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.

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  • Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.

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  • Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for
    veterinary medicinal products.

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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.

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  • 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.

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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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  • Glossary

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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)

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  • Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use.

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