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We can not promise that you will never get a 483
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GMP compliant.
 
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PDA Parenterals Conference

From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin.

This outstanding event will cover the very important topics:

  • Future of Parenterals
  • Packaging and Impact on Quality
  • Manufacturing Flexibility and Control
  • Innovative Plants
  • Monitoring Technologies
  • Medical and Application Devices
  • Regulatory Trends

Don´t miss this interesting conference in Berlin, Germany.

Brochure of PDA Parenterals Conference 2010, October 26-28

 

News about GMP/cGMP

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.

 
2010-03-31

On March 17, 2010 the QP Association announced that it released its database "QPSHARE". The new database allows QPs to increase the efficiency of their companies’ supplier qualification.

 
2010-03-30

EMA published some days ago the Concept Paper on the Revision of the Guideline on Process Validation. This concept paper aims to update the guideline on Process Validation; due to the development of new ICH guidelines Q8, Q9 and Q10, this guideline is being reviewed in order to implement the concepts highlighted in the ICH guidelines.

 
2010-03-29

EMAs Committee for Medicinal Products for Human Use (CHMP) has published the Draft "Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)".

 
2010-03-26

The GMP Experts of Maas & Peither have published an Online GMP Glossary free of charge.

 
 
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