An FDA representative talked about the US-American authority’s perspective as concerns particulate matter in sterile drug products at the ECA conference "Particles in Parenterals" in May this year. Read more here.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has published a Contingency Plan for exceptional waivers intended to apply where it is necessary to ensure the availability of medicinal products. Read more.
With the finalisation of the new FDA Guidance on Process Validation in 2011, a validation life cycle has become state of the art. Accordingly it is planned to partly revise the process validation approach in Europe as well. The European Medicines Agency (ECA) has already issued a concept paper with regard to the EU Annex 15 and asked for comments; Reason enough for the ECA to set up a survey to find out the industry’s thoughts on the planned revision. Find out more about the results.
On behalf of the Eurpean Compliance Academy the team of Concept Heidelberg regularly analyses the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for the first half of fiscal year 2013 (from 1st October 2012 to 31 March 2013). The number of Warning Letters (107) issued by the Center for Devices and Radiological Health (CDRH) and the respective "District Offices" in the first half of fiscal year 2013 is considerably higher. Read more here.
A press release which has recently been published by Health Canada informed about the extension of GMP requirements to APIs. According to these new requirements, the manufacture of APIs will have to be GMP-compliant as of 8 November 2013. Read more here.
The new USP General Chapter <1229.7>, "Gaseous Sterilization" will provide an overview of gaseous sterilization and its validation. The use of sterilizing gases for the preparation of materials and equipment is in widespread application for items that are susceptible to damage by heat or radiation processes. You will find more information in this news.
Holders of an authorisation for generic drugs in the USA are required to comply with the annual deadline for the submission of their self-identification to the FDA. The deadline for fiscal year 2014 ends on 1st June 2013. Read more here.
With a press release dated from 26 April, the European Medicines Agency (EMA) announced the CAT and Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of a combined advanced-therapy product. Read more.
The EU Commission has published the final Template for the Qualified Person's Declaration of Equivalence to EU GMP for IMPs manufactured in third countries. It seems that they accepted some proposals made by stakeholders in their comments. Read more.
The WHO has published a proposal for the revision of its supplementary guideline on GMP validation (Annex 7: non-sterile process validation). The document composed of 11 pages introduces a validation life-cycle and is ... read more here.
Traceability is on everyone's lips. Directive 2011/62/EU - the so-called Counterfeit Directive - calls for the introduction of so-called safety features to enable authenticity verification and the identification of individual packages. Read more here about the latest EDQM activities.
The ASTM norm E2500 should provide a modern and alternative approach to qualification. The classical qualification levels DQ, IQ, OQ, PQ are not mentioned anymore but Subject Matter Experts (SMEs) who should take care of the organisation of verification. Moreover, Good Engineering Practice (GEP) is highly valued. The norm has now been revised. Read more here.
The new Chapter 5 - Production - of EU GMP Guide deals with many aspects which are relevant for quality assurance and quality control, too - like for example the handling of APIs and excipients, concrete requirements on the acceptance of the certificate of analysis of the supplier as well as the opportunities the new chapter offers regarding reduced sampling and reduced testing. Read more here in the News.
The new USP General Chapter <1229.8>, "Dry Heat Sterilization" will provide an overview of dry heat sterilization and its validation. You will find more information in this news and in the Pharmacopeial Forum.