The European Union has published the draft of the delegated act. It defines standards with regard to the technological and organisational requirements for the safety features required in the future. Find out more about the draft of the "Commission delegated Regulation (EU)".
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 previous FDA guideline for herbal medicinal products from 2004 is supposed to be replaced by a new version. In August 2015, the FDA has presented the draft of the revised guideline. Find out more about the FDA Guideline Botanical Drug Development.
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 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.
An in-process revision to USP <1058> on Analytical Instrument Qualification (AIQ) was issued for public comment in the May-June 2015 issue of Pharmacopoeial Forum. Find out more about the changed version of USP General Chapter <1058> - Analytical Instrument Qualification.
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.
The APIC has thoroughly revised the "How to do" document that explains the guideline ICH Q7. Here you can see how the new document interprets the requirements concerning a GMP compliant manufacture of active pharmaceutical ingredients against the background of the current developments.
The 2013 Guidelines on Good Distribution Practice apply to medicinal products for human use. Investigational Medicinal Products (IMPs) are also medicinal products for human use. But is IMP distribution really covered by the new Guidelines?
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
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.
End of 2011 the Pharmeuropa 24.1 published a first draft of the monograph "5.1.2. Biological Indicators in the Preparation of Sterile Products" for discussion. Due to the abundance of comments, the draft was substantially revised and is now available in the Pharmeuropa 27.3 for comments again. Read more about the current Draft 5.1.2. Biological Indicators.
Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market.