MHRA Jeopardizes Lives with Safety Oversight Failures in New “Point of Care” Manufacturing Model

Britain’s Medical Health Products Regulatory Agency (MHRA), now headed by Laura Squire, PhD, a career bureaucrat with no experience in manufacture and regulation of medicines, is moving to a new “point-of-care” manufacturing model. This is a very serious and major departure from long-standing safety oversight and regulation of compliance with the required Good Manufacturing Practices (GMP) that have been the requirements for pharmaceutical companies throughout the modern era of production of medicines since the 1930s. To understand how serious this change and the jeopardy to the public, read more here:  https://open.substack.com/pub/hedleyrees/p/mhras-point-of-care-manufacture

MHRA states in a recent letter: “The proposed mechanism for oversight is a PoC Master File that names the ‘Control site’ and all satellite sites that carry out manufacture of PoC products. The Control site must hold an appropriate license (e.g. MIA or (MIA)IMP) and would be responsible for all satellite sites.” (Note: MHRA is still carrying out ‘distant’ or virtual inspections using Microsoft HoloLens 2 (used all the way through the plandemic). Virtual distant inspections are not suitable for insuring safety and quality in manufacturing to meet the criteria for licensing.

So, where are the Control Sites? Who will be in charge? How many satellite sites will there be? Presumably they are hospital pharmacies, if it is Point of Care manufacture? What skills and experience will the pharmacists and staff in these satellites have? Who will inspect the hospital pharmacies’ quality management systems?”

Hedley Rees, pharmaceutical manufacturing consultant, had submitted a FOI/Open Letter questioning the changes to MHRA Regulations in January 2022 that would allow hospital pharmacies to ‘Manufacture’ COVID injections, even though they did not have the expertise or equipment to safely and properly “finish” the production of these injections. Here is the text of his letter:

“Subject: FOI Request—substantial change in 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors: PART IV “Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products (ATMPs)”

I would like to request information relating to the Subject above, under the FOIA (Please refer to the Appendix for background and supporting information):

1.Is this change fully aligned with EUs REGULATION (EC) NO 1394/2007on ATMPs? (if not, UK can’t sell into EU, as it will be out of alignment with its regulations)

2.Since these new regulations, allowing thawing, manipulation of multi-dose products, etc, were only introduced this year, how was it possible to approve frozen mRNA vaccines under The Orange Guide2017 edition?

3.Has a formal consultation involving UK organizations impacted by the change been undertaken? (MHRA routinely holds consultations, for example “Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety”).

4.Why does the change apply to ATMPs only?5.Given that the change has been implemented, additional urgent questions arise:

1. Under the terms of a Marketing Authorization (MA), the Marketing Authorization Holder (MAH) has full responsibility for the safety of its product(s), and the associated responsibility for pharmacovigilance. How will a MAH fulfil its responsibilities to the license, for an ATMP, when a third-party organization can make unlicensed changes to the product?
2. The same question applies to sponsors of clinical trials for ATMPs.
3. What actions have been taken to ensure that hospital pharmacies (MHRAs example), provide equivalent controls over product quality compared with Good Manufacturing Practice (GMP)? For example, provision of staff training, standard operating procedures, equipment validation, and investigation of quality deviations?
4. What provisions are there for hospital pharmacies to comply with Good Distribution Practice (GDP) also?
5. What is the alternative Quality System for hospital pharmacies?
6. Aside from hospital pharmacies, what other organizations will be allowed to reconstitute ATMPs according to the change? This request is of the utmost urgency, given the current intense activity in the development of mRNA and viral vector-based products (ATMPs), following the SARS-CoV-2 outbreak and the subsequent ongoing programs of inoculation.

Yours sincerely, Hedley Rees, h.rees@pharmaflowltd.com”

Full text and appendix here: https://www.dropbox.com/s/zapi2juxydohw6i/14112022_Open_Letter_MHRA.pdf?dl=0

It’s difficult to overstate the seriousness of breach of long-standing manufacturing quality and safety regulations in the MHRA’s change to Point-of-Care manufacturing, and the degree to which public safety is jeopardized. UK’s MHRA seems to be the “tip of the spear” leading other regulatory agencies (FDA, EMA, etc.) to make similar changes, this is a dangerous change for all Americans to resist. We must communicate with elected officials that this deviation from Good Manufacturing Practices is an unacceptable risk to people’s lives.

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HOST BACKGROUND AND WEBSITE RESOURCES:

Hedley Rees, based in the United Kingdom. Mr. Rees has been providing consultancy on the development, manufacture and distribution of drugs that are fully compliant with the GMP requirements of 21 CFR Title 21, since 2005 through his company, PharmaFlow. Prior to that, he spent 16 years in senior roles in Big Pharma (Bayer) and 10 years in biotech (British Biotech, Vernalis and OSI Pharmaceuticals (now Astellas). Mr. Rees also authored Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics for Wiley, NJ in 2011. His expertise is in the area of anything to do with manufacture through the three phases of clinical trials (and preclinical if required) and ongoing distribution of the commercial supply. Where regulations have been breached, he has a duty to bring this to the attention of regulators, as has been happening with the frozen vials of COVID shots that were shipped only part way finished.

Hedley joins Truth for Health Foundation Team: https://open.substack.com/pub/hedleyrees/p/hedley-joins-truth-for-health-foundation?r=xoehy&utm_campaign=post&utm_medium=web

Follow Hedley Rees on his Substack column, INSIDE PHARMA, where he shares all he can to expose the lies and deceptions that are costing lives and jeopardizing public safety. Watch one of his many interviews here:  https://rumble.com/v14gou4-drug-development-expert-sounds-alarm-over-rushed-to-market-covid-19-vaccine.html

Read more on Facts about SARS-CoV-2 Injections (aka DNA vaccines) and advanced therapy medicinal products (ATMPs): https://open.substack.com/pub/hedleyrees/p/facts-about-sars-cov-2-injections?r=xoehy&utm_campaign=post&utm_medium=web Watch Recent interview discussing the violations of manufacturing processes and regulations that are supposed to keep us safe: https://rumble.com/v1qe9nk-freeman-interviews-hedley.html