#ICYMI – In Case You Missed It – Featured Articles from the Archive
Our expert team has written over 500 insightful articles on all aspects of regulatory affairs. Here, we are highlighting some of the best writing from our recent archive in #ICYMI. In this first edition of #ICYMI we are featuring articles on issues as diverse as Type I variations, Audits, and new quality methods.
Regulatory professionals would generally perceive the Type I variation as a fairly simple regulatory procedure. New figures released by the EMA suggest differently. Statistical data released by the EMA has revealed that 44% of all Type I variation applications received for assessment by the EMA contain errors. It is reasonable to assume that these figures are mirrored for National and MRP variations. The figure of 44% is quite high when you consider that the variations classification guideline for Type I variations is quite detailed. The pharmaceutical industry is always pursuing initiatives to achieve “perfection” in our processes. This lean approach increases efficiency, improves quality and achieves what the Pharmaceutical industry is primarily focused on, providing safe and effective medicinal products to the public. The function of Regulatory Affairs is no different. Identifying areas of improvement and increasing “Right First Time” is a goal of all regulatory personnel. This article details the common deficiency areas with the idea of promoting awareness. Read more here.
Are you making full use of modern manufacturing technologies and innovative quality management techniques? Regulators and manufacturers are under pressure to change their approach and to incorporate new methods in their approach to quality management. We take a look at the pharmaceutical quality system and outline the merits of using it in a manufacturing environment.
The ICH Q10 guideline describes a model for an effective quality management system for the pharmaceutical industry or a ‘pharmaceutical quality system’. It advocates preventative action culture to ensure that actions are taken before problems happen. It also facilitates the use of ICH Q8 and Q9.
It is based on ISO 9000 with an emphasis on management responsibilities, improvement of QS and improvement of product quality over its lifecycle. Its scope is across pharmaceutical drug substances (API) and drug products, including biotechnology and biological products. Read more here.
In accordance with GVP Module I, the MAH is responsible for performing risk-based audits of the quality system at regular intervals including audit of the PV system. The methods and conduct of these audits are outlined in GVP Module IV. Read more here.
We will feature many more articles from our archive as the #ICYMI series progresses. Feel free to share any articles of interest by using any of the links below.