GMP News - Pharmaceutical Technology

15.06.16

Revision of the general Chapter on Pharmaceutical Water in the US Pharmacopoeia

The 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopoeia <1231> Water for pharmaceutical purposes.

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15.06.16

Case Study - Quality Metrics at Aenova: Report from the Pharma Congress 2016

Quality Metrics are a hotly-debated topic. At the end of July 2015, the U.S. FDA released a Draft Guide entitled "Request for Quality Metrics - Guidance for Industry". On the occasion of a keynote presentation at the Pharma Congress 2016, Dr Andreas König - Senior Vice President at Aenova - talked about the practical implementation and the challenges. Read more about Aenova's case study.

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08.06.16

WHO defines Requirements on Zones E and F

In May, the WHO published a draft guideline which describes the recommendations for ventilation systems used in the manufacture of non-sterile dosage forms. It also contains for the first time a definition for microbial requirements with regard to the zones E and F. Read more about the ventilation sytems recommendations.

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25.05.16

WHO issues revised Guideline on HVAC Systems

The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems for the manufacture of non-sterile forms. As most guidelines on this topic address the requirements for sterile dosage forms, the previous version was gladly accepted by industry. Learn more about the revised guideline on HVAC systems.

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25.05.16

EU GMP Annex 1 Revision 2016 - what does the pharmaceutical industry expect?

Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at Boehringer Ingelheim talked in his keynote speech at the Pharma Congress 2016 about the revision of Annex 1 of the EU GMP Guide. Read here what the pharmaceutical industry expects form the new Annex 1.

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13.04.16

New Details on the Revision of USP Chapter 1

As already reported, Chapter <1> of the US American Pharmacopoeia has been revised again. Find out more about the chapter on Injections and Implanted Drug Products (Parenterals)-Product Quality Tests.

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31.03.16

EDQM adopts revised monograph for WFI allowing non-destillation techniques

In a press release the EDQM has announced that the new monograph draft on Water for Injection (169) had been adopted. Read on to learn more about the production of WFI with membrane systems.

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16.03.16

Second Revision of USP Chapter <1> Injections and Implanted Drug Products (Parenterals)-Product Quality Tests

After the revision of the General Chapter on quality testing of sterile medicinal products in the US American Pharmacopoeia had already been announced last year in the USP 38-NF 33, the USP is planning a new revision. Read more about the revision of Chapter <1>.

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24.02.16

Can the ventilation of GMP clean rooms be switched off overnight?

The ventilation systems of clean rooms consume a lot of energy. Therefore, the question comes up again and again whether one might switch off the ventilation of the rooms overnight or when they are not used in order to save energy. Read more about GMP clean rom ventilation systems.

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03.02.16

Frequent Asked Question: Which Level of Ozone is Required in a Hot- or Cold-Stored WFI System?

Ozone can be used for the sanitisation of water systems. Which level of concentration is required in water - i.e. in WFI - depends on different factors. Read more about the sanitisation of water systems with ozone.

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27.01.16

ISO 14644 - Part 1: The Long-Awaited Final Version on Cleanroom Classification

Part 1 of ISO 14644 entitled "Classification of air cleanliness by particle concentration" is one of the most  important norms in the GMP environment as it is the only technical norm which is directly referred to in a GMP guideline document: the currently applicable Annex 1 of the EU GMP Guide. The revision process of the norm has been lasting for years but now it seems to have come to an end. Find out more about the revised ISO 14644.

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27.01.16

Are Terminal Sterile Filters in Water Systems permissible?

One of the most frequently asked questions in the pharmaceutical environment is why so much effort is made for purification and storage/ distribution of water for pharmaceutical use. Especially microbial contamination - the highest risk - could be avoided by using terminal sterile filters at the points-of-use.

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13.01.16

New FDA Guideline on Certification of Medical Gases

The FDA has recently published a new Guideline as a draft which describes the certification process of medical gases i.e. gases for direct administration to human beings or animals. Read more about the FDA Medical Gases Certification Guideline.

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25.11.15

Revised USP Chapter <1790> on Visual Inspection published

After the long-awaited Chapter <1790> on visual inspection of injections was first published in the PF 41(1) as a draft the USP has now submitted a revised draft in the PF41 (6). Read more about the revised draft of the USP Chapter <1790>.

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11.11.15

USP revises Chapter <1231> on Pharmaceutical Water

The Pharmacopeial Forum 41(5) comprising changes to the fundamental monograph on pharmaceutical water of the US-American Pharmacopeia <1231> Water for Pharmaceutical Purposes has been published for comments. Read more about the changes in the pharmaceutical water monograph.

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