As concequence of the adopted new regulations of GMP for ATMPs, the European Commission published a revised version of the Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use".
The board of the ECA Foundation's "Analytical Quality Control Group" wants to strengthen the lifecycle approach to analytical development. Therefore, the Group developed a new guideline on "Analytical Procedure Lifecycle Management". Find out more about the content of the new APLM Guideline and on how modern analytical development should be conducted today.
The FDA recently finalized its October 2017 draft guidance on how to handle amendments to generics submissions by publishing the final guidance ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA.
The aim of the International API Inspection Programme is the cooperation of authorities in monitoring and controlling API manufacturers. Read here, by which measures an optimised bundling and efficiency enhancement of the regulatory supervision of API facilities via GMP inspections are to be reached.
While EU and FDA GMP Guidance is very similar, there are also some areas where there are known differences. It is worthwhile being aware of these differences when dealing with companies and authorities from the "other side".
After considering public comments FDA received about the draft guidance on “Statistical Approaches to Evaluate Analytical Similarity” issued in September 2017 the agency decided to withdrew the proposal. The guidance was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.
Glycerin is often used as an excipient in solid and semisolid dosage forms. For companies supervised by the FDA, comprehensive testing of the incoming excipient is mandatory. Otherwise, they risk receiving a warning letter, like an Irish pharmaceutical company recently did. The deficiencies the FDA inspectors found in the areas of quality control and quality assurance are described here.
Drug manufacturer IDT Australia Ltd. received an FDA warning letter in May 2018. It was criticised during the FDA inspection that OOS results of assay determinations had not been investigated and that a batch had been released even though three consecutive identity tests had failed. Read more about the IDT Australia FDA warning letter here.