GMP NEWS 2013

GMP Guideline Manager Version 15.0 released

The European Compliance Academy's (ECA) GMP Guideline Manager CD is a very useful tool, providing all relevant guidelines on a single CD. It is distributed to all members of the ECA. This year the CD was issued in its 15th edition. Read more.

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Is there going to be "GMP Rating"?

Janet Woodcock from the FDA has published a very interesting report in the Nature Publishing Group. As leader of the CDER, she has one of the most important positions within the FDA. Read more here.

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

After Switzerland, Australia is the second country to get on the list of countries who won't have to issue "Written Confirmations". Read more here.

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New FDA Guidance for the Prevention of Cross Contamination of Beta-Lactam Antibiotics

In April the US authority FDA issued the finalised Guidance paper with recommendations on the separation of the manufacture of not-penicillin Beta-Lactam antibiotics. Read more.

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New USP Chapter on Inhalation Drug Products

The USP plans the publication of a new general chapter on quality requirements for inhalation and nasal drug products. At the same time, another chapter should deal with the performance characteristics of these products. More information can be found here.

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FDA offers eLearning for eCTD Implementation

The FDA has launched a new service on the website. You can get information on the eCTD topic thanks to Web-Based-Training. Further courses are in preparation. Read more here.

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EMA publishes Updated Procedural Advice for Centralised Marketing Authorisations

EMA's "procedural advice" documents provide important recommendations and answers to questions about the centralised procedure for medicinal products. These documents have been recently brought up to the current state of the art. Read more here.

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CTD Format for Traditional Herbal Medicinal Products

You can find information on where to find the quality requirements on the CTD format for traditional herbal medicinal products in the draft of an EMA/HMPC Guideline. Read more in the News.

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

The transfer of analytical methods is one of the new requirements in the revised Chapter 6 - "Quality Control" of the EU GMP Guide. The transfer of the test methodology from one laboratory to another has to be described in an written protcol. Please see this news for further information.

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EudraGMP Database now also comprises GDP Information

The European Medicines Agency (EMA) has upgraded its EudraGMP database so that it now contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP). Read more.

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Written Confirmations: Questions & Answers Document Version 4.1 published!

The EU Commission has published a new update of the Questions & Answers document on the "Written Confirmation". Version 4.1 presents answers to 2 new questions on topics which hadn't been clarified so far. More details here.

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FDA Guidance for Industry on Validation of Blood Establishment Computer Systems

Blood establishments use different and very specific computer systems. The FDA's new Guidance for Industry "Blood Establishment Computer Systems Validation in the User's Facility" published in April 2013 takes into consideration the particularities and validation approaches of such computerised systems. Read more here.

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Written Confirmations: Time is running out - new EU Progress Report

The EU Commission has published a progress report giving an overview on 20 major countries and their status of preparation for adhering to the new rules. It seems there are still quite a few challenges. Read more.

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Change Control: New SUPAC Guidance published

FDA has published a new draft Guidance for Industry: SUPAC - Manufacturing Equipment Addendum. The guidance document is being distributed for comment purposes. Read more.

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Comparison of EU GMP and Indian GMP Requirements for APIs

Within the framework of the Written Confirmations to be issued as of 2 July 2013, the question of how equivalent GMP regulations in different countries are is being raised. A comparison of EU's GMP Part 2 (ICH Q7) and the Indian GMP regulations is now available. Read more here in the GMP News.

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Quality Standards on Recovered Solvents in the Manufacture of Herbal Medicinal Products

Recovered / recycled solvents may be used in the manufacture of herbal preparations. But which quality requirements apply to such solvents? According to the "EMA/HMPC Concept Paper", a new guideline on the standards to be used should be elaborated. Read more in this News.

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FDA publishes GMP Requirements for "Combination Products"

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 medical products, medicinal products, and ... Read more here.

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Sample Documentation on EU Site Master File published

The introduction of the EU Site Master File (Part III of the EU GMP Guide) has significantly changed the requirements on the creation of a company description. The very precise instructions have all disappeared. New requirements have been added. A sample documentation shows how to take into account the new requirements in a SMF. Read more here.

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How many Validation Runs are State-of-the-Art today?

For many years the "magical three validation runs" completed successfully were regarded as state-of-the-art in order to be able to define a process as validated. But in the new FDA Guidance on Process Validation no number of validation runs is mentioned any more. How many runs are state-of-the-art today? Read more.

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Harmonisation of Bacterial Endotoxin Testing - ICH guideline Q4B Annex 14

In May 2013, the new ICH Q4B Annex 14 for bacterial endotoxin tests in the ICH regions will become effective. More details can be found here.

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