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TOP 5 GMP Downloads

1. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.

 

2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.

 

3. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.

 

4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.

 

5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

 

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News about GMP/cGMP

2010-04-20
 
2010-04-19

On April 1, 2010 European Pharmacopoeia Commission published information concerning a survey to possible changes regarding Water for Injection.

Currently, the European Pharmacopoeia only allows distillation for the production of Water for Injection (WFI). Renewed discussions have taken place at the end of 2009 amongst regulators in Europe on the suitability of using Reverse Osmosis (RO) to produce WFI. Concerns from regulators regarding the use of RO for the production of WFI had previously been expressed in a reflection paper issued by the Joint CHMP/CVMP Quality Working Party in early 2008.

 
2010-04-16

EFPIA (European Federation of Pharmaceutical Industry and Associations) published the results of their product verification system pilot project on April 12, 2010. The pilot successfully demonstrated a product verification system at the point of drug-dispense of a swedish pharmacy chain. The system is based on a 2-D data matrix code.

 
2010-04-15

On April 7, 2010 CDERs Division of Drug Information (DDI) published a Drug Information Update concerning the changes to the Heparin Sodium USP Monograph.

 
2010-04-13

On 12 April 2010 we have relocated the Maas & Peither's German headquaters to a new address.

 
2010-04-07

On April 2, 2010 FDA published the Annexes 7 "Dissolution Test General Chapter" and 9 "Tablet Friability General Chapter" to the Guidance for Industry "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions"

 
2010-04-06

EMA's Quality Working Party (QWP) has published its Work Plan for 2010.

 
2010-04-01

On March 26, 2010 FDA published the Final Guidance for Industry "Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages".

This guidance is intended to address provisions set forth in Section 505D of the Federal Food, Drug, and Cosmetic Act (the Act) regarding development of standardized numerical identifiers (SNIs) for prescription drug packages. In this guidance, FDA is identifying package-level SNIs, as an initial step in FDA’s development and implementation of additional measures to secure the drug supply chain.

 
 
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