GMP News - APIs and Excipients


Which kind of GMP Documentation is needed for an API Manufacturer who performs Sterilisation of an active Substance

The European Medicine Agency publishes answers to frequently asked questions after they are discussed and agreed to by the GMP/GDP Inspectors Working Group. In April 2011 the Agency published the following statement. Go here to read more.



WHO publishes Notice of Concern regarding GMP Deviations about two Manufactures located in India

The WHO Notice of Concern are very similar to FDA Warning Letters. These letters will be issued  to a manufacturer, contract research organization or quality control laboratory, by the WHO Prequalification of Medicines Programme. Read more about the two new Notice of Concerns here



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.


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