GMP NEWS 2014

An improved method of measuring water vapour permeation for solid oral dosage forms like tablets or capsules has been discussed during a USP - PQRI Workshop and presented in the Pharmacopeial Forum. See the detailed information.

USP's general chapter on dissolution testing <1092> should be revised. In the future, there should be greater differentiation between the dissolution testing method and the subsequent assay of the API. More information can be found here.

The European Medicines Agency (EMA) is establishing new roles for handling variations. Read more.

In March, the FDA published a new Guidance as draft which is supposed to limit overfill of vials with drug products intended for injection. Read more.

Currently the requirements for the qualification of analytical instruments and computer-based systems from USP < 1058 > do not match those from the GAMP® Good Practice Guide for validation of computerized systems in the laboratory (2nd Edition, 2012). In this news, a publication will be presented that shows one possible way of solution.

The EMA Database EudraGMDP is a major achievement for GMP and GDP compliance information.  Since parts of the data are now publicly accessible, it makes it easier to get important information relevant for supplier qualification. In our GMP News we list the 2014 updates for GMP-Non-Compliance.

Companies who want an authorisation for generic tablets or capsules in the USA should consider certain requirements with regard to the physical attributes of these dosage forms. The provisions can be found in a FDA Guidance for Industry recently published. Read more here.

The Center for Devices and Radiological Health (CDRH), responsible for medical devices at the FDA, publishes new guidelines and programmes on a regular basis. In this news you will find a short and selected overview of new, modified, or updated guidelines and programmes.

At the end of March, the FDA announced in the Federal Register that changes to 21 CFR 860 (Medical Device Classification Procedures) were planned. The changes to 21 CFR 860 are required to fulfil the necessary provisions from the "Food and Drug Administration Safety and Innovation Act (FDASIA)".