QP update April 2020
What is happening in the world of QP as we all get used to a new way of working?
Kudos to all of you who are keeping the country supplied with medicines, working hard in manufacturing sites, distribution sites, hospitals, and pharmacies and of course your own homes around the country. For those of you trying to home-school your kids at the same time – we all owe you a drink!
I will cover the specific impact of the COVID-19 pandemic in a separate post, but here is a very brief roundup of some things you may have missed over the last few months:
NITROSAMINE IMPURITIES
A comprehensive website is available from the EMA here to provide guidance on how to perform assessments regarding the risks of potential for Nitrosamine impurities in pharmaceutical API which includes information on regulatory requirements and a Q&A document. NOTE: The deadline for completing and submitting the initial risk assessment has been extended to 01 Oct 2020.
SAFETY FEATURES
A very useful aide memoire has been issued by the EMA for use by inspectors to assist in confirming compliance with the requirements of Regulation 2016/161 implementation of safety features. Great for ensuring that you have everything in place that you should before the inspector comes calling, find it here.
ATMP IMPORT TESTING EXEMPTION
Despite Part IV of volume 4 of EudraLex being a long complex document, there are clearly some areas still requiring clarification.
One of these is, ‘does an ATMP require retesting if imported from a third country?’ Given that most ATMP batch sizes are too small for duplication of testing to be practical, the EMA have issued a short Q&A on the subject. As always, the answer depends on risk, must be fully documented and form part of the Marketing Authorisation (or CTA). See the document for full text.
DRAFT ANNEX 21 PUBLISHED
Importation of Medicinal Products for both human and veterinary use. The Annex is aimed at MIA holders and covers only the physical importation into the EU/EEA. Consultation is open until 20 Jun 2020.
ANNEX 1 DRAFT 2
A second targeted stakeholder consultation is being held on the second iteration of Annex 1 – manufacture of sterile products. This is intended to speed up the process after the working group had to go through over 6000 comments on the first draft.
If you wish to comment on this draft you have until 20 May 2020 but must funnel your comments through one of the identified organisations e.g. the PHSS or the PDA. See here for all the relevant information.
RSSL have put together a fantastic series of free Webinars on sterile manufacturing including discussion and analysis of Annex 1 with the wonderful Dr Tim Sandle click here for links to on-demand and future sessions.
BREXIT PREPAREDNESS BY PETER MOLLISON
Great presentation from Pete regarding the potential impact of Brexit on the UK pharmaceutical supply chains for Clinical Trial product (IMP).
Click here for more information.
MEDICINES AND MEDICAL DEVICES BILL 2019-2020
Click here for all the relevant documents
I know you all think I am a sad, sad bunny reading legal documents; but you MUST read this!
Most of the news stories on this Bill, which was put before parliament on 13th Feb 2020 say that the Bill introduces the following:
NHS hospitals will be able to use innovative, personalised medicines for unique cancers and diseases
The new bill means hospitals can use patient tissue and DNA samples to tailor treatments to individual patients when other medicines have failed, or to develop drugs that have a shelf-life of minutes and would otherwise be unavailable to them
Increase the range of professions able to prescribe medicines in low-risk circumstances
Introduce new regulations on medical device
Actually, only one of these is true. Click HERE to read the full story.
EMA PUBLISHES REFLECTION PAPER ON GOOD MANUFACTURING PRACTICE AND MARKETING AUTHORISATION HOLDERS (MAHS)
With the increase in use of 'virtual' business models in the Pharmaceutical Industry many MAHs are not directly involved in the Manufacturing, testing and distribution of their products.
This reflection paper provides clarification of the activities that may be outsourced / delegated versus responsibilities that may not.
You might think that this would be a short document simply reminding the MAH of the requirements of GMP, after all it's common sense isn't it?
In actuality the document is 31 pages! This can provide a company, and the QP, a roadmap to compliance.
You can contribute to the development of new guidance via the Consultation which closes 17 April 2020.
#GMP #QP #MAH
WHAT IS DIVERSION OF A MEDICINAL PRODUCT?
Two recent MHRA press releases have highlighted the issue of diversion of medicines from the legitimate supply chain.
Link: Pharmacist sentenced for supplying drugs on the black market 14 Jan 2020
Link: Son of pharmacy owner sentenced for dealing wholesale medicines 27 Jan 2020
Both relate to community pharmacies ordering large quantities of prescription only medicines, including controlled drugs, and selling these on to criminal gangs.
Diversion is the transfer of medicines produced by reputable manufacturers for legitimate purposes, transferred outside the normal supply chain for illicit or illegitimate use.
Anyone with an MIA/WDA who is involved in the sale or supply of medicinal products must comply with Good Distribution Practice (GDP) and qualify their customers (bona fide checks). In addition to assuring that they hold all applicable authorisations for the type of medicines in question there are certain actions that are required to be performed related to prevention of diversion.
These actions include:
Monitoring transactions for irregularities in sales patterns - particularly for narcotics, psychotropic substances or drugs known to be misused
Flagging unusual order quantities, eg high volumes ordered by small community pharmacies
Investigation of discrepancies noted
Notification to competent authorities where required
The focus on this type of criminality by the MHRA has had a real impact according to a press release from Feb 2019 with 32 investigations and 86 suspects arrested or interviewed under caution and a reduction in diversion of Diazepam by 73%.
If you are working in the legitimate supply chain ensure you have the relevant processes in place to detect such activity. You are not responsible for the actions of criminals; you ARE expected to conduct all appropriate due diligence to prevent criminal activity.
#WDA #FMD #Diversion #RP #Customer Qualification
