GMP News - APIs and Excipients


Extension of Directive 2003/94/EC to GMP for APIs - EU Commission publishes Comments on Concept Paper

The intention of the EU Commission to integrate GMP regulations for APIs into the existing Directive 2003/94/EC via a delegated act faces rejection from companies and industry associations. Their comments on the respective concept paper from the EU Commission have been recently published. Read more here.



Chinese SFDA issues new Regulation on a strengthened Supervision of Pharmaceutical Excipients' Manufacturers

The new regulation of the Chinese State Food and Drug Administration defines a strengthened supervision of the manufacture of pharmaceutical excipients. Read here who will be affected by these new provisions.



New Rules for the Importation of APIs - a European Commission Leaflet provides Information

The new rules for the importation of active pharmaceutical ingredients will already enter into force next year. As of 2 July 2013 each consignment of active substances imported into the EU must be accompanied by a written GMP conformity certificate. The European Commission comments once again the most important questions concerning the written confirmation in an information leaflet. Read more here.



EDQM publishes Guidance on Notifications of Changes of CEPs

The EDQM has recently published a document intended as a guide for the renewal or revision of a certificate of suitability. The EDQM hopes that this will reduce the time needed for the procedure and limit requests for additional information from CEP holders. Read more about this very helpful document here.



Top 10 Deficiencies - Applications for Certificates of Suitability (CEP)

The EDQM has published a document about the most frequent deficiencies found in application dossiers for CEPs and gives recommendations on how to avoid such errors. Read more here about these "Top Ten Deficiencies".



Continuing Trend: Again, Numerous Warning Letters issued to European API Manufacturers

For some time now, the FDA has been strengthening its inspection activities at API facilities not only in the Far East but also in Europe. The analysis of the 8 Warning Letters which have already been issued for fiscal year 2012 confirms this trend. Read more here about what FDA investigators mostly have to object to in European facilities.



EU GMP Part 3: New Final Document on Written Confirmation

On 10 July 2012, the European Commission published the final Template for the 'written confirmation' for active substances. Please read more here



APIs from China and India - will Import go down in 2013?

APIs produced in third countries in Asia (like China and India) can only be imported into the EU if the regulatory authority of the exporting country will issue a written confirmation of GMP Compliance. The MHRA has published concerns that some APIs might not be available if the authority in the third country will not issue the necessary written confirmation. Please read more.



GMP Requirements for Pharmaceutical Excipients: NSF International publishes new Draft Standard

The U.S. American Standard Organisation NSF International has published a draft document containing relevant provisions regarding GMP and GDP for pharmaceutical excipients. Read more here.



Import of APIs from Third Countries into the European Union: Template for the written Confirmation of GMP Compliance published for Comments

In addition to the Anti-Counterfeiting Directive 2011/62/EU, an importation certificate must be delivered by the regulatory authority to import APIs from Third Countries into the EU. The EU Commission has recently published such a document for comment. Read more here.



Several API manufacturers in China, India and Brazil found out of GMP compliance

In the past weeks and months a number of manufacturers from China, India and Brazil were informed by EDQM that their CEP will be suspended or withdrawn. Read more here



EMA works on Recalculation of Limits for Cleaning Validation

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.



Publication of the Danish Medicines Agency about Requirements regarding Updates of Active Substance Master Files

Changes to the applicant part and the restricted part of an Active Substance Master Files may lead to misunderstandings - particularly if the API manufacturer and the marketing authorisation holder fail to communicate efficiently which possibly results in various versions and approval times. The Danish Medicines Agency has addressed the question and published it. Read more here.



EXCiPACT - A new Certification Scheme for Excipients has been launched

On 1st February, 2012; the IPEC Federation announced the successful launch of EXCiPACT - its new, voluntary international certification scheme designed and developed to assure cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients. Please read more here.



Significant Administrative Changes in the New Revision of the Guideline on the ASMF Procedure

The latest revision of the Guideline on the Active Substance Master File Procedure mainly shows administrative changes supposed to harmonise the whole procedure and the communication between the ASMF holder and the Authorities. Read more here.


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