GMP NEWS 2015

With the publication of a draft on the revision of Annex 15 at the beginning of February 2014, changes in the area of validation/qualification were to be expected. Even then, the European Compliance Academy (ECA) started an industry survey. Now the final document is ready and the changes will become valid on 1 October 2015. How does the industry see the new requirements in Annex 15?

The draft for a guideline ICH M7(R1) published recently supplements the ICH-M7 guideline published last year. Read more about the calculation of compound-specific acceptable intakes of genotoxic impurities.

The EDQM recently revised its certification policy. Read more here about what you now need to consider when applying for a Certificate of Suitability (CEP).

The requirements described in the ICH Q3D Guideline on testing for metal impurities do not apply to all pharmaceutical products. In its latest press release for products outside the scope of ICH Q3D, the EDQM clarified what manufacturers of these preparations, e.g. manufacturers of veterinary medicinal products, still need to be aware of.

An antibiotic had to be recalled in Germany as a supplier was not originally qualified. This was announced by the manufacturer in a press release.

After FDA and EU have raised concerns about Good Manufacturing Practice implementation at a number of Indian companies, now the Word Health Organisation (WHO) also found serious GMP deviations. The company Svizera Labs located in Mumbai, India, received a Notice of Concern - a letter similar to the FDA Warning Letters. Read more about the WHO Letter of Concern to Svizera Labs

On 17 August, the FDA published the finalised Guidance for Industry and Food and Drug Administration Staff  "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices".

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?

The ECA regularly evaluates the FDA Warning Letters. What is new in the first half of the 2015 fiscal year (1 October 2014 to 31 March 2015)? The answer is actually nothing. Actually? Find out more about the current specifically medical devices related developments in the top 5 list.