NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Agreed Dendream. Perhaps there is a misunderstanding about the “certification.”

The GMP compliance certificate issued to a pharmaceutical manufacturing facility by MHRA after conducting the inspection by MHRA inspectors is called the “Certificate of Compliance” or MHRA certificate for the concerned facility.

A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice.

Although the facility is in the UK, and the regulator is the MHRA, the inspection process is similar to the FDA’s as outlined here:

FDA Takes Quality Systems Approach to CGT Inspections
Jerry Chapman
November 12, 2020

In June, CBER Division of Manufacturing and Product Quality Facilities Reviewer and Investigator Ekaterina Allen spoke at the ISPE Biopharmaceutical Manufacturing conference about the current regulatory landscape for cell and gene therapy products. Part I covered her remarks about the current manufacturing challenges. This is the second part of the series and it looks at the most common agency observations made during inspections of cell and gene therapy manufacturing facilities by the quality system.

When an FDA inspection team performs inspection, it is done using a systems approach that has been developed by the agency. There are seven key systems that are looked at during CGT inspections:
* Quality
* Production
* Facilities and equipment
* Materials
* Laboratory control
* Packaging and labeling
* Donor eligibility (this is mostly for allogeneic products)

In every system, there are three elements that are evaluated: standard operating procedures (SOPs), training, and documentation. Depending on what type of inspection it is the scope is a little different. If it is the first inspection—a prelicensing inspection—the inspection team is trying to evaluate all the key systems. If it is a Team Bio inspection, they will look at the quality system and then pick and choose depending on how in-depth an inspection was planned and what they see during the inspection. . . . .

https://redica.com/pharma-fda-takes-quality-systems-approach-to-cgt-inspections/