The recent discovery about the fraudulent replacement of vegetal oils as emulsifiers with toxic plasticizers in the products of two Taiwanese companies has led both the FDA and the IPEC Europe to publish warning notifications. Read more here about the incident.
In a 46 page report, the Swedish Medical Products Agency (MPA) presents an initiative aiming to introduce environmental constraints into the EU GMP Guidelines. The reason for this is based on the near inexistence of environmental concerns in the countries where the manufacture of APIs is outsourced. Read more here about this initiative.
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.
The EU Commission has published a new Draft Guideline on Good Distribution Practice. This new takes into consideration the regulations of the Directive on Falsified Medicines and should replace the existing regulations which have been valid since 1994. What this implies for the pharmaceutical wholesale can be read here.
There is still a lot of uncertainty about how the three guidelines should be used in combination. A new Points to Consider document is intended to provide clarification. Please find more information here.
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
The Generic Pharmaceutical Association (GPhA, USA) has published two examples of development reports to show how generic manufacturers (ANDA application) can implement Quality by Design and document in front of the Agency (Office of Generic Drugs, FDA). Read more here.
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.
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.
In May, the FDA published a Draft Guidance for Industry and FDA Staff entitled "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". The document should … Read more here.
On 1 January 2011, FDA joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) . Now, Dr Margaret A. Hamburg, Commissioner of the FDA, gave an interesting talk about the membership and its benefits. Read more.
A drug and a device, a drug and a biological, a biological and a device, or maybe even all three can create a combination product. But what regulation is applicable for those products? Which new Guidance documents will be published soon? Please read more about this development in a very detailed article provided by the IPQ - one of the most important Journals in the GMP and regulatory environment. Read on here.
On 1 April 2011 the FDA and the EMA started a pilot project (see our GMP News from 6 April 2011) for the evaluation of QbD authorisation applications. On 17 June the two authorities informed about the first dossier within the pilot programme which was issued by Pfizer. Read on here.