All Updated Pharma EU Guidelines EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines

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All Updated Pharma EU Guidelines EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines

EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines

Part I

Basic Requirements for Medicinal Products

Operation Date

1 Chapter 1 – Pharmaceutical Quality System 31-Jan-13
2 Chapter 2 – Personnel  16-Feb-14
3 Chapter 3 – Premise and Equipment 01-Mar-15
4 Chapter 4 – Documentation Jan-11
5 Chapter 5 – Production 01-Mar-15
6 Chapter 6 – Quality Control 01-Oct-14
7 Chapter 7 – Outsourced activities 31-Jan-13
8 Chapter 8 – Complaints and Product Recall 1 March 2015
9 Chapter 9 – Self Inspection

Part II

Basic Requirements for Active Substances used as Starting Materials

11 Basic requirements for active substances used as starting materials 13-Aug-14

Part III

GMP related documents

12 Site Master File 2010
15 Q9 Quality Risk Management September 2015
16 Q10 Note for Guidance on Pharmaceutical Quality System June 2008
17 MRA Batch Certificate 1 June 2011
18 Template for the “written confirmation” for active substances exported to the European Union for medicinal products for human use  January 2013
19 Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities 20 November 2014
20 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  March 2016.
21 Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials) NA
22 Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders 23 July 2021

 EU Annexures

Date

24 Annex 1 Manufacture of Sterile Medicinal Products  25 November 2008
25 Annex 2  Manufacture of Biological active substances and Medicinal Products for Human Use 26 June 2018
26 Annex 3 Manufacture of Radiopharmaceuticals 01 September 2008
27 Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
28 Annex 5 Manufacture of Immunological Veterinary Medicinal Products
29 Annex 6 Manufacture of Medicinal Gases 03 February 2010 
30 Annex 7 Manufacture of Herbal Medicinal Products 01 September 2008 
31 Annex 8 Sampling of Starting and Packaging Materials
32 Annex 9 Manufacture of Liquids, Creams and Ointments
33 Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
34 Annex 11 Computerised Systems 30 June 2011 
35 Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products
36 Annex 13 Manufacture of Investigational Medicinal Products 03 February 2010
37 Annex 14 Manufacture of Products derived from Human Blood or Human Plasma 30 November 2011
38 Annex 15 Qualification and validation 30 March 2015
39 Annex 16 Certification by a Qualified Person and Batch Release 12 October 2015
40 Annex 17  Parametric release  26 December 2018
41 Annex 19 Reference and Retention Samples EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines

All Updated Pharma EU Guidelines EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines

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