Which UK MP is brave enough to ask “Questions in the House” about the quality of conformance and compliance of C10 injections?
In life, if you have no idea what quality is and the value of that quality, it matters naught whether you receive anything of quality at all.
Check out the quality control requirements passed into UK law here, updated on the UK Government website on 9 December 2022:
There is a lot of reliance on European regulations and those of foreign countries.
And compare with the independent analysis of the Pfizer/BioNTech injection by the European Medical Agency that has this summary sheet of manufacturing quality control failures in the 40 minute video below:
Maria Gutschi - Review of Quality Issues with mRNA Injections 5 Nov 2022 (bitchute.com)
There is also this in the video about the sources of variability.
The person completing the analysis is Maria Gutchi. Maria is a pharmacist and a regulatory specialist from Canada.
She has thoroughly reviewed Pfizer's manufacturing documents and identified glaring and unsolvable problems.
The product should be considered adulterated. Note that the quality tests described in Pfizer's documents only apply to batches (bulk product) and do not specify any product conformity tests at the dose level (as administered). This is a glaring violation of existing regulations for pharmaceutical products.
Perhaps an MP in the UK Parliament could ask to see the compliance and conformance reports that ensure that the dosages that were administered were had the same ingredients as those in the clinical trials and were not contaminated to the degree that the analyst described as “adulterated products” and get answers to the other issues raised in the video and on the summary image clipped from the end of the video.
Here are a few of quality requirements passed into UK law, keep in mind that, whereas the US Department of Defence is solely responsible for administering injections and neither it, nor any pharma companies or health regulatory agencies have any responsibility for injuries and deaths that have been caused by the injections, this does not apply to any other country – including the UK:
“Quality
The supply of batch EJ0553 is authorised providing that:”
Pfizer/BioNtech ensure that all drug substance and drug product manufacture outside the UK is in accordance with EU GMP and the Human Medicines Regulations 2012 (as amended) in facilities with current EU GMP certificates or other acceptable and suitable authorisation to MHRA.
QP certification is provided for the final dosage form and applying the approach and standards in EU GMP Annex 16.”
This part is particularly important. GMP = Good Manufacturing Practices.
“Any importation or manufacturing facilities located within the UK must be authorised by the MHRA to handle Regulation 174 products. All drug substance and drug product manufacture must be in accordance with EU GMP and the Human Medicines Regulations 2012 (as amended) in facilities with current EU GMP certificates or other acceptable and suitable authorisation to MHRA.”
There is the term EU GMP again.
“Compliance with GMP requirements is documented in the QP check sheets and Pfizer/BioNTech provide these to the MHRA for each batch along with the QP certificates of conformance. QP certification must take into NIBSC certification process, as this in itself does not imply release to market.
QP certification declares: (i) compliance with all stages of EU GMP (where non-compliant, a gap analysis must be performed, and captured on the QP checksheet), and (ii) that the batch has been manufactured as per the dossier supplied (currently Emergency Use Authorisation).
A certificate of conformance with GMP and the conditions of this authorization must be generated by the releasing QP and supplied to the onward supply chain.
Further batches are authorised for supply, subject to batch specific approval by MHRA and providing that the full product lifecycle is in compliance with the conditions specified above in relation to batch EJ0553;
Pfizer/BioNTech must provide relevant additional characterization data regarding drug product manufacturing process and product quality reasonably requested by MHRA, and will provide relevant additional characterization data regarding drug product manufacturing process and product quality, whether or not requested by MHRA, as soon as they become available.
Any changes to or deviation from the manufacture of the product must be notified to MHRA for approval on allocation of the batch to UK use.”
Although much of the analysis and laws apply to Pfizer BioNTech, we already know that Moderna was “busted” by the US FDA for poor quality manufacturing standards in the US – albeit an arbitrary rap on the knuckles because Moderna is not subject to FDA controls, it is only answerable to the US Department of Defence.
Recall of Moderna C19 Injections? - by Peter Halligan (substack.com)
“OBSERVATION 1
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.
OBSERVATION 3
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in characteristics of the in-process material and the drug product.
OBSERVATION 4
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to ensure that batches of the drug product meet appropriate statistical quality control criteria as a condition for their approval and release.”
Of course, given the track record of incompetence and wilful blindness exhibited by the 650 MP’s sitting in the House of Commons – barring a handful of notable exceptions AND the 755 out of 798 eligible to attend proceedings at the House of Lord’s, do not expect there to be any accountability for shoddy workmanship leading to death and injury any time soon by any politicians – let alone the regulatory authorities that endorse using Midazolam to kill the elderly and inform, or the SAGE group that advises the UK government on ways to be incompetent.
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Andrew Bridgen