Incredible and Alarming GMP Violations
15/08/2013 01:04
Incredible and Alarming Violations in Warning Letter issued to Wockhardt Limited - See more at: https://www.gmptrainingsystems.com/GMPtips/?p=2018
Article archive
Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
15/08/2013 01:04
In June, the FDA published a "Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture".
This document addresses manufacturers of licensed Whole Blood and blood components intended for...
EU-GMP: New Annex 16 released
15/08/2013 00:55
The European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release".
As one important topic, it has been pointed out that the major task of a Qualified Person (QP) is the certification of a batch for its release. In this...
New WHO Initiative "Good Pharmacopoeial Practices"
15/08/2013 00:53
The WHO started the new initiative "Good Pharmacopoeia Practices" with the goal to harmonise the procedures and the regulations for pharmaceutical standards. It is supposed to support authorities in ensuring the quality of pharmaceutical raw materials and finished products.
The background for the...
WHO publishes Variations Guideline for Prequalified APIs and Medicinal Products
15/08/2013 00:50
In May 2013, the WHO released its new Technical Report (TRS 981) including 4 Annexes entitled:
Release procedure for International Chemical Reference Substances (Annex 1)
WHO guidelines on quality risk management (Annex 2)
WHO guidelines on variations to a prequalified product (Annex...
Final EMA Variations Guideline on Procedures Issues and Classification of Variations published
15/08/2013 00:48
According to Commission Regulation (EC) No 1234/2008 regarding the examination of marketing authorisations for medicinal products for human use and veterinary medicinal products, detailed provisions on the variation procedure and on the category of variations have to be set in separate guidelines....
USP expert answers questions regarding particulate matter testing
15/08/2013 00:44
1. Which analytical performance characteristics are required for the (light obscuration) method verification?
Both USP 788 methods provide a robust and reproducible particle content determination which many companies have collected over an extended history, and are appropriate for most product...
Guideline on the European Drug Master File Procedure updated
15/08/2013 00:42
The "Guideline on Active Substance Master File Procedure" which was developed by EMA's Quality Woring Party, describes the procedure that can be used to document an API's quality for a regulatory authority. This guideline was already revised several times since it was initially issued in 2006. The...
WHO Guideline on Quality Risk Management finalised
15/08/2013 00:40
Annex 2 of the new Technical Report 981 is a new WHO guideline on the implementation of a quality risk management system. The aim of this guideline is to assist the implementation of a QRM system, covering activities such as development, manufacturing, sourcing of materials, testing, packaging and...
MHRA implements new Software for risk based Inspection Planning
15/08/2013 00:38
As part of its risk-based inspections regime which ensures compliance with statutory obligations relating to medicines the Medicines and Healthcare products Regulatory Agency (MHRA) is implementing new IT software.
MHRA inspections across all the disciplines will be better prioritised as a result,...
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