GMP News - APIs and Excipients


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months a number of manufacturers from China, India and Brazil were informed by EDQM that their CEP will be suspended or withdrawn.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.



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

The Directive on the prevention of the entry of falsified medicinal products into the legal supply chain obliges the EU Commission to adopt the guidelines and principles of good manufacturing practice for APIs by means of a delegated act in form of a directive. In a first step, the Commission has published a concept paper for comment. Read more here.



Inadequate Validation of Analytical Methods remains permanent Topic in Warning Letters to API Manufacturers

The use of not validated or inadequate analytical procedures and the lack of a GMP compliant qualification of analytical instruments - these are violations against basic GMP regulations in the analytical lab the FDA keeps on finding during inspections of API manufacturers. Read more about the analysis of API Warning Letters in the past fiscal year - here.



GMP non-Compliance causes further CEP Suspensions

The EDQM, the European Directorate for the Quality of Medicines and Healthcare has suspended a number of CEPs following a GMP inspection recently. For more information please click here.



Drug Master Files (DMF) - Recorded Webinar with FDA Dr Arthur B. Shaw

On Monday 14 November 2011, the FDA presented a webinar entitled "Introduction to the Drug Master File (DMF)". A recording of this webinar is now available.To see this webinar at no cost please click here



Anti-Counterfeiting Directive requires Import Certificate for the Import of APIs from Third Countries into the EU

Very soon third countries will only be allowed to export Active Pharmaceutical Ingredients (APIs) to the EU if an accompanying letter confirms that the exporting country fulfils certain requirements with regard to GMP regulations. This written statement is not necessary if the specific country was evaluated positively by the EU Commission before. Learn more about the first steps towards a new regulation which will become effective on 2 July 2013.


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