Construction of a new Sterility Suite with zero impact on customers
Why upgrade? Regulations are in some cases open to interpretation and it is up to the individuals to justify any interpretations made with real world data and suitable scientific analysis. Sometimes though, buildings constructed over a decade ago require a re-assessment against current expectations, with a realisation that what was fit for purpose at the … ContinuedRead more
Tepnel Pharma Services introduces Accelerated Stability Assessment Programme (ASAP) to its Stability Testing Portfolio
Stability studies are a time consuming and resource intensive task during the development of new drugs. Accelerated Stability Assessment Programme (ASAP) is an approach based on the Arrhenius equation whereby degradation increases with temperature and therefore using appropriate testing vessels and statistical analysis, it is be possible to project the degradation rate at low temperature … ContinuedRead more
Tepnel Pharma Services have invested in Fusion QbD software
Quality by Design (QbD) is a systematic approach to development that begins with setting a predefined objective and harnessing scientific understanding and risk based principles to establish a controlled process or in pharmaceutical drug development terms, product intended to avoid loading too much dependence on an end point QC test system that rejects too many … ContinuedRead more
MRA comes into force between the FDA and the EU
The first of November 2017 has become a notable and unprecedented date in the history of medicines regulation. This is the first day of coming into force of a Mutual Recognition Agreement (MRA) of Good Manufacturing Practice (GMP) inspections of manufacturers of medicines for human use between the FDA and the EU. This initial stage … ContinuedRead more
Impact of Brexit on the Regulation of Medicines and the Pharma Industry?
We have a unified Medicines regulatory system in the European Union and Economic Areas. The UK regulator is a significant player in respect of European regulatory procedures and is recognised as a source of considerable scientific and regulatory expertise. Now we have Brexit and a schism which will eventually arise as the UK leaves the … ContinuedRead more
When is an IMP not an IMP? When it’s an AMP.
The definition of Investigational Medicinal Product (IMP) and the use of Auxiliary Medicinal Product (AMP) are the subject of a recent consultative document from the European Commission’s expert group on clinical trials for the implementation of regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. The consultative document was published on … ContinuedRead more
Reflection on GMP/GDP Consultative Committee Minutes: 18th April 2016
The GMP/GDP consultative committee met recently on the 18 April 2016 at the MHRA offices in Buckingham Palace Road, London. The attending bodies consisted of quality associations, Industry associations and professional organisations. Among the many interesting topics discussed were the topical subjects of data integrity and harmonisation.Read more
GXP data integrity culture and unity
If you turn to that font of all known knowledge, the internet and search the term “data integrity” you will find a common definition of “maintaining and assuring the accuracy and consistency of data over its entire life-cycle”. All in all this is not a bad definition.Read more