GMP NEWS 2012

On behalf of the US FDA the Department of Justice has filed a Consent Decree of permanent injunction against the generic drug manufacturer Ranbaxy. The manufacturer agreed to remedy GMP deviations and to correct data integrity issues at several plants in India and in the US. Get more information here.

When the FDA Process Validation Guidance mentioned the ASTM Standard E2500-07 in connection with modern approaches to qualification, interest was raised in this document. But the Standard is relatively short and not very specific. Now, interpretation is offered by an ISPE-Guide.

The new pharmacovigilance package and its regulations which are entering into force in April and respectively in July this year prompt questions - mainly regarding deadlines for renewal applications for medicinal products authorisations. The EU Commission has published a Q&A document to answer these questions and to clarify further ones (e.g. about the pharmacovigilance system master file). Read more here.

In a new Recommendation on for Risk-Based Inspection Planning in the GMP Environment, the PIC/S asks Inspectors to have a look at job cuts. Read more.

In the January - February issue of USP'S Pharmacopeial (PF) a stimulus to the revision process was published for USP <1058> on Analytical Instrument Qualification. The proposal is based around a more detailed risk assessment for all apparatus, instruments and systems used in a regulated analytical laboratory. This USP General Chapter <1058> is currently under revision. The GAMP GPG for Laboratory Computerised Systems is also under revision and is due to be published in Q2 this year. You will find more information here.

The Chinese Ministry of Health has published revised GMP rules for drugs in the beginning of 2011. March 1, 2011 was specified as date for the entry into force. Now, an English translation is available. Read more about the main differences between the Chinese GMP rules and EU GMP Guideline Part I.

The U.S. Food and Drug Administration (FDA) recently published a draft Guidance on Monitoring Crude Heparin for Quality. Read more.

The USP published comments and responses to General Chapter/Section: <1032> Design and Development of Biological Assays. Read more here.

Experts from the European Medicines Agency (EMA) will meet at the end of February to discuss the calculation of the maximal acceptable carry-over for product changes in multipurpose facilities. This will probably lead to changes in the determination of limits for cleaning validation. Moreover, further statements are expected regarding the obligation to manufacture highly active substances in dedicated facilities. Read more here.