Through its inspection programme, the MHRA has encountered numerous examples of API manufacturing sites that are named on marketing authorisations but are not currently used and not fully maintained as approved suppliers. Please go here to read more.
In August 2010, the WHO published a draft guideline on quality risk management (QRM). The document is astonishingly detailed and gives, among others, guidance on official inspections regarding QRM. Read more here.
The final Reflection Paper on expectations for electronic source data and data collection tools in clinical trials has been published. It outlines the current opinion of the EU GCP Inspectors Working Group. Read more.
Alongside validation, the (GMP-compliant) operation of computerised systems is also becoming an increasingly higher priority. A new GAMP Good Practice Guide gives comprehensive support on this matter. Read more here.
The number of clinical trials conducted in India is still increasing. According to a report created by the Federation of Indian Chambers of Commerce and Industry in co-operation with the consulting firm Ernst&Young, as many as 7% of all clinical phase III studies performed worldwide are already carried out in India. Our news highlights the reasons.
Jeff Shuren, Head of the Center for Devices and Radiological Health (CDRH), has announced on the FDA website that the FDA intends to further the development of improved medical devices. With the example of infusion pumps, Shuren explains… Read more here.
With the revision of the WHO Technical Report Series (TRS) No. 957 in June 2010, the WHO's expectations on the manufacture of sterile medicinal products were published as a draft for an Annex 6 "Good manufacturing practices for sterile pharmaceutical products". Read more here.
Due to new toxicity studies in rats and mice, the solvent Isopropylbenzene is meant to be categorised as Class 2 instead of Class 3. A corresponding ICH draft guideline has been published and released for commenting by the public. Here you will find the details.
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Read more about the programme.
Impurities, like heavy metals, residual solvents and genotoxic substances, may have to be included in the drug substance specification depending on the point in time when they are formed or introduced into the synthesis process of an active pharmaceutical ingredient. On this issue, the EMA has described a harmonised policy on its Q&A page. Read more here.
Which requirements do plastic packaging materials intended for packaging solid oral dosage forms and for packaging active pharmaceutical ingredients have to fulfil? The EMA's Q&A section provides important information.