GMP News - Quality Assurance

Current scientific data on the occurance and risk of Posttransfusion Purpura (PTP) were published on  the Advancing Regulatory Sciences site of the US Food and Drug Administration. Read more about the Data on Posttransfusion Purpura (PTP).

Some time ago we published a GMP News about the SOPs which are required according to the GMP regulations. This time we will list the records which are demanded by US law. The FDA will demand these records either by paper or by electronic means. Please read more about GMP records required in the cGMP Guide.

At the beginning of each year the FDA always publishes a list of the guidances it plans to publish during that year. It has done so again in 2015. The document is relatively comprehensive, containing five pages. Find out more about the Guidances the FDA plans on publishing in 2015.

Starting with the 1 March 2015 the revised EU GMP Guide Part I, Chapter 8 (Complaints, Quality Defects and Product Recall) becomes effective. Until then the version with the validity date 1 February 2006 is still valid. A matrix provides a compact overview of the changes. Find out more.

Again and again, Warning Letters keep on reprimanding GMP-violations of the handling of electronic data. In some cases, the FDA urgently recommends the support of an external consultant. Read more here about what FDA's expectations regarding consultants are.

In one of our GMP Newsletter issues in April 2013, we reported about FDA's new GMP regulations for Combination Products (combination of a medical device with another product, e.g. a drug). These regulations came into force on 22 July 2013 as 21 CFR 4. The scope of these GMP provisions is relatively "light" and has been drafted in a kind of Question & Answer form. Now, the FDA has released the draft of Guidance on GMP requirements for Combination Products.