GMP Review Vol 20 No.2
GMP Review Vol 20 No.2

GMP Review Vol 20 No.2


GMP Review Vol 20 No.2 2021

The latest issue includes articles on:

Survey of qualified persons on Article 52 of Directive 2001/83/EC and code of conduct - by Dr Ulrich Kissel and David Cockburn

The survey responses reveal that most countries have not established a professional code of conduct for qualified persons (QPs). Sanctions in response to misconduct are primarily defined by law. However, the primary intent of a professional code of conduct is to support QPs in avoiding professional misconduct in their day-to-day working environment by following sound professional principles laid down in such a code. Feedback shows that in practice this is a generally neglected and under-developed topic. We should be mindful that a key principle of a professional code of conduct is that cases of potential misconduct are judged by professional peers, i.e. QPs. This contrasts with breaches of law which are assessed by lawyers. The European Qualified Person Association (EQPA) sees this as a remarkable gap in the transposition of Directive 2001/83/EC that needs to be addressed. Professional discussion on Article 52 and its consequences are almost non-existent with the result that many QPs are currently not aware of this gap and what they are missing out on. The EQPA’s own recently updated Qualified Persons Good Practice Guide was identified by some members as an ideal way to fill the gap.

Subvisible particle testing: towards international harmonisation by Tim Sandle

The compendial text for subvisible particles, an important release test for liquid parenteral solutions and other pharmaceutical products, is being revised with the aim of achieving harmonisation between the European, USA and Japanese pharmacopoeia. The revision process will include an expansion of scope (in relation to the range of products to be examined). This article looks at subvisible particle testing, considering its importance and key issues, before concluding with a consideration of the intended pharmacopoeial revision. Non-visible particles are allowed, the limit values depend on the size and the test method used. Particles smaller than 25μm
are considered subvisible.

What’s stopping doctors from repurposing generic medicines? Answer – not a lot! by Hedley Rees

For decades, it has been assumed only pharmaceutical companies have the wherewithal to develop or repurpose medicines. This article challenges that assumption based on changing business models in the industry. These changes have created a skills-base of qualified contractors and contract organisations able to offer
everything required to bring a medicine to market. 

The message to doctors, other health professionals and healthcare systems (herein referred to as doctors) is that there is just one gap in their armoury - knowledge of the supply chain that delivers medicines to patients. 

We conclude with suggestions on how the gap could be closed with surprisingly little extra effort.

Regulatory update. 

Developments in the “regulation” of the pharmaceutical industry

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