GMP News - Analytical Quality Control

21.08.19

Warning Letter due to Deficiencies in the Purified Water System

In June, a US-American pharmaceutical manufacturer received a Warning Letter from the FDA due to deficiencies in the Purified Water System which concern - among other things - the design of the water system, monitoring, sampling and handling of CAPAs.

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21.08.19

MRA: Can Import Testing be completely stopped now?

The MRA with the USA is now in force as planned. But there is a lot to be considered in order to stop import testing.

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19.08.19

Warning Letter due to GMP Deficiencies in Tableting

An Indian manufacturer of solid dosage forms recently received a Warning Letter from the US FDA after the authority had revealed serious deficiencies in the tablet production.

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31.07.19

WHO publishes Draft Guideline on Production of WFI using Non-Distillation Methods

The WHO has reacted to the changes in the European Pharmacopoeia by issuing a draft guideline on the production of WFI (Water for Injection). The commentary phase is open to the public, comments can be submitted until 20 September 2019.

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31.07.19

Brexit: Industry should keep Timelines for Batch Testing Facilities

The EMA points out that - independent from the Brexit postponement - MAHs should use the remaining time to complete all necessary preparations.

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24.07.19

Recent Changes to the USP - What You Need to Know

The USP is currently introducing some changes to the format of the USP and to its online platforms. Amongst others the USP plans to discontinue printing the USP-NF in the current format.

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17.07.19

Do liquid, sterile medicinal products have to be particle-free?

According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.

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17.07.19

New structure of Ph. Eur.´s packaging section

The numbering of the Ph. Eur. packaging section 3 has been changed for the 10th Edition following the creation of the new chapter 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.

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10.07.19

Creams, Gels & Pastes redefined

A revised version of the Ph. Eur. Monograph Semi-solid preparations for cutaneous application has been published in Pharmeuropa.

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12.06.19

Revised USP Elastomeric Components Chapters

The previous draft chapters were canceled. Therefore, USP´s General Chapters–Packaging and Distribution Expert Committee has published new proposals on elastomeric components.

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12.06.19

German Pharmacopoeia Draft Monograph for Cannabis Extracts

A draft for a new German Pharmacopoeia monograph entitled "Cannabis Extract, Standardized (Cannabis extractum normatum)" has been published in the (German) Bundesanzeiger.

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12.06.19

MHRA plans to apply AQbD principles

The MHRA plans to apply analytical quality by design principles, including the analytical target profile (ATP), to its pharmacopoeia (BP).

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05.06.19

Revised USP Chapter <1226> Verification of Compendial Procedures

The revised USP general chapter <1226> VERIFICATION OF COMPENDIAL PROCEDURES has been approved.

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29.05.19

Revised USP chapter <3> Topical and Transdermal Product Quality Tests

The revised USP general chapter <3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT QUALITY TESTS has been approved.

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02.05.19

FDA Warning Letter: GMP Deficiencies at US Pharma Manufacturer, e.g. in Water System

The FDA has recently issued another Warning Letter to an US pharmaceutical manufacturer describing serious GMP deficiencies. This concerns among others the water system, the QC laboratory and quality assurance.

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