A large part of the Warning Letters sent by the FDA in fiscal year 2014 was addressed to "compounding pharmacies". Against this background, the statistics of the most frequent deviations highlight other focuses. Read more here.
Indian pharmaceutical manufacturers increasingly attract attention by breaching GMP rules. In a further case the analysis results not complying with the requirements were deleted and the batch was released for the US market. Read more.
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.
FDA has published a new Manufacturing Equipment Addendum for the SUPAC Guidelines (Scale-up and post-approval changes), describing the administration's expectations when assessing manufacturing equipment changes. Read more.
The ICH Q3D Guideline recently published has been integrated into EMA's set of rules. The coming into force of the requirements laid down in this guideline now underlies defined deadlines. Read more here.
With the Drug Supply Chain Security Act (DSCSA) and the related implementation plan over a ten year period dated from 2013 new requirements were defined in the USA which are to improve the traceability of prescription drugs within the supply chain. Now the start has been postponed by means of an FDA Guideline that was released already in December 2014. Read more.
The US Food and Drug Administration has initiated a comprehensive new organisation of their inspection activities. One of the key elements of this initiative is the Quality Metrics Program. This program will throw a complete new light on the compliance status of each manufacturing site. Please read more about Quality Metrics in this GMP News.
In December 2014, the Food and Drug Administration, Center for Biologics Evaluation and Research published the guidance on "Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture". Read more here.
The FDA has published a Draft Guideline with recommendations for human cells, tissues, and cellular- and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff for the criterion of minimal manipulation. Learn more.
Our article deals with the implementation of the EU requirements into national law of the EU Member States and uses Germany as an example. In Germany, GDP implementation is laid down in the Trade Regulation for medicinal products. Nevertheless, the regulation contains some ambiguous formulations which lead to problems for implementing GDP. Read more about the implementation of GDP in Europe.
The ECA Good Distribution Practices Group and the Pharmaceutical Quality Control Group have initiated a Working Group to develop an interpretation of the EU GDP Guideline. In order to better access the documents a new menu button has been added to the Members Area. Please read more here.