New cGMP and Regulatory documents
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	Expected draft Notes for Guidance from CPMP/QWP: Note for Guidance on Excipients, Note for Guidance on Packaging
21-mar-2002	FDA Guidance, Electronic Records, Electronic Signatures, Time Stamps
	FR Sep 24, 2001 (vol 67 No.54) [page 12999] Notice: Availability of Draft Guidance for Industry on Electronic Records, Electronic Signatures, Time Stamps (1 page) (htm)
	21 CFR Part 11; Electronic Records; Electronic Signatures - Time Stamps - Draft Guidance  (12 pages) (pdf) Comment by June 18, 2002
7-mar-2002	CPMP/CVMP/QWP draft Note for Guidance on the European Drug Master File procedure, Feb 2002, CPMP/QWP/227/02 (pdf)  Deadline for comments 31 aug 2002 the draft proposes to make mandatory  the use of the Ph. Eur. Certification Scheme for existing substances that are in the Ph. Eur.  Deadline for comments on that specific issue 30 apr 2002
	CPMP (QWP) draft Note for Guidance on Stability Testing of Existing Active Substances and Related Finished products, Feb 2002, CPMP/QWP/122/02 (pdf) Deadline for comment aug 2002 remark on the front page: A revision of CPMP/QWP/556/96 - revised to bring in line with ICH Q1A and CTD -
30-jan-2002	ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents. The ICH has separated a list and table of permitted daily exposure (PDE) of solvents from its guidance to be able to update the PDE of solvents without having to republish the entire guidance. For information, see the FDA-CDER site (htm)
14-jan-2002	Drug Manufacturing Inspections (Compliance Program Guidance Manual for FDA Staff. 7356-002) (htm) See important background information (htm)
11-jan-2002	General Principles of Software Validation  (NB: re. Medical Device Spoftware) Final Guidance for Industry and FDA Staff, January 11, 2002 (pdf)
12-dec-2001	Note for Guidance on Chemistry of the New Active Substance CPMP/QWP/130/96/Rev1 (pdf) Deadline for comments 30-jun-2002

10-aug-2001 CBER Guidance

Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components - (pdf) Comment by Nov 13, 2001

View comments from PDA to FDA (13 Nov 2001): Cover letter (PDF) | Comments (PDF)

19-jul-2001 Active Pharmaceutical Ingredients

ICH guideline (Active Pharmaceutical Ingredients) published as annex to the EU Guide to Good Manufacturing Practice, Eudralex Volume 4

On 18th July 2001, the Commission adopted a new legislative proposal which introduces a requirement for pharmaceutical manufacturers to use only active substances which have been manufactured according to GMP in the manufacture of medicinal products. Until this comes into force requirements for GMP for active substances and hence the applicability of this guideline will not be mandatory in the EU. However when there are causes for concern, or when required by certain Member States, GMP inspections of active ingredient manufacturers may be carried out by the competent authorities of Member States. In these cases, and in particular when these are performed in the context of an application for a centralised authorisation, it has been agreed that the inspectors of the competent authorities in the EU will inspect against the requirements in this guideline, now published as Annex 18 to the EU guide to Good Manufacturing Practice.

Annex 18

12-jul-2001 New annexes to the EU Guide to Good Manufacturing Practice, Eudralex Volume 4

Following discussion within the Working party on medicines and inspections, 4 new annexes to Eudralex Volume 4 of the Rules governing medicinal products in the Community have been finalised. Annex 6 is a revision to the current annex on Manufacture of Medicinal gases and should replace current requirements from September 2001. Annex 15 on Qualification and Validation is also due to come into operation In September 2001. Annex 16 concerns the arrangements for Certification by a Qualified Person and Batch Release in the Community and is due to come into operation from January 2002. Annex 17 addresses Parametric Release and is also due to come into operation in January 2002. These annexes will also be translated into the current language versions of Eudralex Volume 4.
Links:
Annex 6 Manufacture of Medicinal Gasses

Annex 15 Qualification and validation

Annex 16 Certification by a Qualified Person and Batch Release

Annex 17 "Parametric Release"

EudraLex Volume 4 this links will take you to the entire EU-GMP document incl. all annexes

28-mar-2001 FDA (CDER/CBER):

Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing, March 2001

FDA is announcing the availability of a guidance for industry entitled "Monoclonal Antibodies Used as Reagents in Drug Manufacturing." This guidance focuses on the chemistry, manufacturing, and control (CMC) issues that should be addressed in NDA's, ANDA's, BLA's, their supplements, or IND's. This document is not intended to cover mAb's used as diagnostics, radiolabeled imaging agents, or therapeutic products. In the Federal Register of June 24, 1999 (64 FR 33868), FDA announced the availability of a draft version of this guidance. The June 1999 document gave interested persons an opportunity to submit comments through September 22, 1999.

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01-mar-2001

CPMP Notes for guidance:

Draft Note For Guidance (QWP) on Quality of Water for Pharmaceutical Use

Adopted Note for Guidance (QWP) on Process Validation

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06-feb-2001

Draft revised version of Annex15 of the GMP: Validation master plan : Design qualification, installation and operational qualification, non-sterile process validation, cleaning validation for information.(see 12-jul-2001 above)

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26-jan-2001

Revised Draft of Annex to the Guide to Good Manufacturing Practice for Medicinal Products: Certification by a Qualified Person and Batch Release (available for comments until 15 March 2001) (see 12-jul-2001 above).