Article archive

Handling of APIs and Excipients - New Guidelines in Chapter 5 of EU GMP Guide

22/05/2013 21:30
On 17 January 2013, the European Commission published the re-revised version of draft chapter 5 - Production - of the EU GMP Guide for comment. The chapter entitled "Production" deals with many aspects which are relevant for quality assurance and quality control too - like, for example, purchasing,...

Dry Heat Sterilization - New USP General Chapter <1229.8>

22/05/2013 21:27
According to a proposal in the Pharmacopeial Forum 39 (3) the USP General Chapter <1211> "Sterilization and Sterility Assurance of Compendial Articles" will be separated in several individual chapters. One of these chapters - <1229.8> - will address "Dry Heat Sterilization". This...

Written Confirmation: Australia gets on the List of "Third Countries"

22/05/2013 21:25
Starting from 2 July 2013, all APIs manufactured outside the EU have to be accompanied by a written confirmation issued by the monitoring authority in the exporting country confirming the GMP compliant manufacture of the APIs. This requirement doesn't apply to countries whose supervision and...

Brazil's GMP Guideline Available in English

22/05/2013 21:23
In a globalised world, it is interesting to consider pharmaceutical markets outside the classical regions Europe, USA and Japan like, for example, South America. Conversely, this means that the monitoring authority in the country which imports medicinal products is able to perform a GMP inspection...

FDA offers eLearning for eCTD Implementation

22/05/2013 21:22
The Food and Drug Administration (FDA) has launched a new service. Each interested party can attend so-called Web-Based Training (WBT) courses via internet. The first course developed within this programme presents an overview of the submission of Electronic Common Technical Document (eCTD). In...

Revision of the EU GMP Guide: EU Commission Proposal for Chapter 6 - Quality Control

22/05/2013 21:20
On 17 January 2013, the EU Commission published the draft of the revised Chapter 6 Quality Control of the EU GMP Guide. The reason for the change was the inclusion of a new section on technical transfer of testing methods and other items such as out of specification (OOS) results. With regard to...

Written Confirmations: Questions & Answers Document Version 4.1 published!

22/05/2013 21:18
The requirements on the importation of APIs in the EU have grown drastically because of the relevant provisions laid down in Directive 2011/62/EU, article 46b(2)(b). As of 2 July 2013, each API import in a EU member state will have to be accompanied by a "Written Confirmation". This situation...

Comparison of EU GMP and Indian GMP Requirements for APIs

22/05/2013 21:14
Because of the new requirements for importing APIs from non-EU countries, the question of similarities and differences in GMP guidelines of the different countries is being widely discussed. In cases where GMP Guidelines in non-EU countries are found to be comparable to those in the EU, and if...

FDA publishes GMP Requirements for "Combination Products"

22/05/2013 21:09
As of 22 July 2013, cGMP requirements on combination products will apply in the USA as 21 CFR Part 4. But what are combination products? These are composed of a medical device, a medicinal product, and/or a biological product. A combination product comprises two or more of all these products as a...

FDA 483 Observation caused by wrong SOP for Method Transfer

31/03/2013 22:51
FDA 483 Observation caused by wrong SOP for Method Transfer An inspection of a drug manufacturer ended with several observations were related to inadequate transfer of analytical methods. In one instance the SOP did not require the receiving laboratory to demonstrate suitability for intended use No...
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