Actuele regelgeving met betrekking tot GMP en GDP.

  • Introduction

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  • 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.

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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 (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and  of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)

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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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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 (2018)

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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 (2018)

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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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