MHRA resumes inspections of SARS-CoV-2 injection manufacturers—3 years too late!!!

Distance inspections mean no inspections

GMP & GDP Certificates: Validity Period Extended

Above is the title of an email I received this morning. These Certificates allow manufacturers and distributors to operate, but with no physical inspections, they are worthless. Below is what the email says:

Posted by: Ian Jackson, Posted on: 11 December 2023 - Categories: Good distribution practice, Good manufacturing practice

Following the end of the COVID-19 public health emergency declared by WHO in May 2023^[1], on-site GMP and GDP inspections were restarted after being postponed or carried out remotely during the pandemic.  A number of postponed inspections still need to be carried out and we are working at pace to complete these inspections as soon as possible. The validity of GMP and GDP certificates has currently been extended until the end of 2023.  The MHRA (in consultation with our international partners) has decided to continue the extension of the validity date until 2024^[2] or until the conclusion of the next inspection, whichever comes first, except where clarifying remarks in the certificate state otherwise.

In the meantime, we reserve the right to perform risk-based supervision of sites by either on-site  or remote inspections  and, based on the outcome, may continue to issue, withdraw or restrict GMP and GDP certificates as appropriate.

Inspections will continue to be prioritised based on risk so that the highest priority manufacturers and wholesale distributors are inspected first. In addition, inspections will be prioritised if the GMP or GDP certificate is already five years or older.

It is incumbent upon manufacturers, importers and distributors to continue complying with GMP and GDP as appropriate.

Inspections  may be carried out at any time, and in case of serious non-compliance, appropriate regulatory actions will be taken.

What does this mean?

It confirms what we already know