GMP News - Analytical Quality Control

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.

more

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.

more

10.04.19

USP Published New Drafts for General Chapters on Plastic Materials

In the current issue of the Pharmacopeial Forum, the USP general chapters on plastic packaging materials have been re-published for comment.

more

03.04.19

ICH M10 - Draft Guideline on Validation of Bioanalytical Methods published for public Comments

On 13 March, the Euroepan Medicines Agency (EMA) published a the draft ICH Guideline M10 on bioanalytical method validation for public comments.

more

13.03.19

Is an Identity Test needed for the content of all Containers?

In a recent Warning Letter, FDA is criticising a Chinese company for their inappropriate identity testing.

more

06.03.19

Brexit: EU supports pharmaceutical Companies

In a letter, the EU Commission explains possible exemptions for future batch testing in the UK.

more

06.03.19

Warning Letter due to Serious Deficiencies in Quality Control

FDA inspectors usually expect a minimum level of GMP understanding for identity and assay determinations of starting materials and finished products. Read here which basic GMP deficiencies in the quality control laboratory have led to a Warning Letter regarding incoming goods controls and testing of finished products.

more

27.02.19

Monographs on radiopharmaceutical preparations - Revised Guideline

At the beginning of the year, the EDQM published a revised version of its guidelines for the preparation of monographs on radiopharmaceutical preparations. It now includes a new section on method validation.

more

19.12.18

Revision of EMA's Guideline on the Use of Pharmaceutical Water

In the course of the revision of the European Pharmacopoeia which allows the production of WFI with other methods than distillation, the revision of EMA's "Guideline on the quality of water for pharmaceutical use" has become necessary.

more

19.12.18

New Ph. Eur Monograph on PAT adopted

The European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts including the general chapter on PAT - Process analytical technology (5.25).

more

03.12.18

New ICH Topic Q14 and Revision of Q2

A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH Q14 guideline Analytical Procedure Development and the revision of Q2(R1) Analytical Validation.

more

15.11.18

Stability by Design - Guidelines for Assessing & Controlling Physical Stability

The USP Physical Stability Joint Subcommittee has published a Stimuli article regarding Guidelines For Assessing and Controlling the Physical Stability of Pharmaceutical Raw Materials, Intermediates, and Dosage Forms. 

more

31.10.18

New Timeline for USP Plastics Packaging Chapters

The USP posted a new timeline for the implementation of the plastics packaging chapters 661.1 and 661.2. So far, the new chapters were to become applicable on May 1, 2020. The implementation of the new requirements will now be delayed until December 1, 2025.

more

24.10.18

FDA Warning Letter: Outlier Test inadequate for OOS Investigation

The API manufacture Zhuhai United Laboratories Co. Ltd. received a Warning Letter from the FDA in June 2018. The FDA criticized that the OOS results of assay determinations haven't been adequately investigated. According to the FDA, the sole use of outlier tests is not appropriate. Read more about FDA's Warning Letter to Zhuhai United Laboratories.

more

17.10.18

Missing Investigation of OOS Results leads to FDA Warning Letter

The API manufacturer Keshava received a Warning Letter from the FDA in March 2018. During the inspection, it has been criticised that no corrective actions had been taken for Out-of-Specification results and that a few analyses missed complete data. Read more here about the FDA Warning Letter for Keshava Organics.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics