GMP News - APIs and Excipients


Excipact - the Certification Scheme for Pharmaceutical Excipients

The Certification Scheme for pharmaceutical excipients elaborated by IPEC Americas, IPEC Europe and three further European partner associations contains standards for Good Manufacturing and Distributing Practices as well as requirements for 3rd party audit organisations and their auditors qualification. Learn more about the programme here.



The Falsified Medicines Directive published in the Official Journal of the European Union

On 1 July 2011 the Falsified Medicines Directive (2011/62EU) has been published in the Official Journal of the European Union. Now the countdown has started for the transposition of the Directive into national law by the EU Member States and for the adoption of Guidelines for APIs and pharmaceutical excipients by the EU Commission. Please read here more about the comprehensive legislation changes to come.



FDA announces New Worldwide Strategy on GMP Supervision and Importation

The manufacture of drugs, food, and medical devices is strongly fragmented and largely globalised. Because of this fact, there is an increase in the number of monitored manufacturing sites and imported products. This is a current issue in the USA. To meet new challenges, the FDA reacted with a strategy report. Read more here about the FDA planned change in strategy.



New ICH Q11 Guideline published

On June 16, 2011 the ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) was published as a Step 3 document. Read more here.



The Council of the European Union adopts Falsified Medicines Directive! Major challenges for Users and Producers of APIs and pharmaceutical Excipients to be expected

The Falsified Medicines Directive has been adopted by the Council of the European Union on 27 May 2011. It is now about to be published in the Official Journal of the European Union within the next days. It contains substantial changes with respect to GMPs for APIs and pharmaceutical excipients. Please read here more about these new challenges for the API and pharmaceutical industry.



Suspension and Withdrawal of CEPs by EDQM

The EDQM announced on May 17, 2011 the availability of the revised policy document 'Suspension or Withdrawal of a Certificate of Suitability'. The EDQM also annouced information about new CEP suspensions and withdrawals due to failures to comply with the GMP requirements. Read more here.



Quality by Design for pharmaceutical Excipients - IPEC publishes new Checklists and Q&A Document

Three new documents published by the IPEC provide useful information for suppliers and users of APIs on Quality by Design at early stages of development.  Read more here.



New PIC/S Document on GMP for APIs

A new document created by a PIC/S team of APIs experts raises the central issue related to the production and distribution of APIs and provides essential answers and clarification on the topic. Read more about the interesting collection of Questions and Answers here. 



EDQM requires more Information on the Manufacturer's Localisation (DUNS/GPS) for CEPs

From 15 April, the European Directorate for the Quality of Medicines and Health Care (EDQM) requires for applications or revisions of a Certification of Suitability (CEP) the indication of the manufacturing site localisation with GPS data or a DUNS number. This change is in line with the requirements laid down in the new EU Site Master File. Read more here



Video Presentation from FDA´s Dr Moheb Nasr available

A presentation from Dr Moheb Nasr about FDA´s Pharmaceutical Quality Initiatives was videotaped at the 13th European API Conference in Barcelona. Click here to read more.



Amended Directive 2001/83/EC includes stronger Guidance on GMP for APIs and Excipients

The amendmends to the directive 2001/83/EC regarding the prevention of the entry of falsified medicinal products into the legal supply chain were adopted by the EU Parliament on 15 February. These amendments will affect many central fields of drugs manufacturing. As a consequence, the GMP regulations for pharmaceutical APIs and exicpients are going to be tightened. Read more.



EMA plans on focusing more on API Manufacturers located in Asia

The EMA reacts on the fact that the manufacturing of APIs is moving to areas outside the EU, especially to Asia (mainly China and India). Read more here.



ICH Q11 Draft Gelling On Lifecycle/Change Management and Control Strategy Components

The lifecycle management section of the newest working draft of ICH's Q11 guideline on drug substance development and manufacturing provides allowance for applicants to include change management proposals in their original submissions. Read one here.



Revision or Renewal of CEPs: Requirements for Notifications to the EDQM

The EDQM has to deal with an increasing number of deficiencies in the notifications regarding revisions or renewals of CEPs which makes the procedure inefficient and which could be easiliy avoided. Here you can read more about the most common deficiencies found in the documents submitted to the EDQM.



Part 2 EU GMP Guide on APIs Will No Longer Be Identical to ICH Q7

The European Commission published a revised Part 2 text on GMP for APIs which will enter into force by 31 July 2010. Click here to read more.


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