GMP News - Pharmaceutical Technology

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.

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.

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>.

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.

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.

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.

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.

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.

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>.

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.

22.10.15

WHO publishes draft guideline for HVAC systems for non-sterile pharmaceutical dosage forms

The WHO published a revised working document of the guideline which specifically addresses the requirements for HVAC systems used during the manufacture of non-sterile pharmaceutical dosage forms for public consultation in September.

14.10.15

USP wants to considerably expand the Monograph for Ophthalmic Preparations <771>

In the Pharmacopeial Forum 41(5), September 2015, the USP published a detailed draft revision of the monograph for ophthalmic preparations <771>.

30.09.15

Are Metal Detectors mandatory in Tableting?

The European Medicines Agency (EMA) maintains a site with answers to frequently asked questions regarding GMP. This has been updated this year and now also comprises the question about the use of metal detectors in tableting.

09.09.15

Exceeding the AQL Limits in the 100% visual Inspection

In addition to trending the results of the 100% visual inspection, inspection of AQL random samples has been established as part of the batch release process. But what happens if the limits in the AQL test are exceeded?

26.08.15

Number of samples in PQ/validation of a fully automated 100% visual inspection system

The performance qualification (PQ) or analogously to the validation, a fully automated inspection system in the 100% visual inspection, is carried out by comparing humans and machines. The intention is to show that machine inspections are not worse than human ones. But what number of test samples in PQ/validation of a fully automated (100%) visual inspection is required for a valid comparison?

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