Medicines and Healthcare products Regulatory Agency
Report No : Insp GMP/IMP 46334/14567004-0007
STATEMENT OF NON-COMPLIANCE WITH GMP
Part 1
Issued following an inspection in accordance with :
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on
17/05/2022
, it is considered that
it does not comply with the Good Manufacturing Practice
requirements referred to in
-
Regulation 331 of The Human Medicines Regulations 2012 (SI 2012/1916)
-
Regulation 2 of the current Veterinary Medicines Regulations
-
Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)
The Manufacturer :
Marfleet Analytical Services Limited
Site address :
Marfleet Analytical Services Limited, Wyke House, Wyke Works, Hedon Road, Hull, HU9 5NL, UNITED KINGDOM
- The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17(3) of the Human Medicines Regulations 2012 (as amended)
- The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17(3) and C17 of The Human Medicines Regulations 2012 (SI 2012/1916)
- The principles and guidelines of Good Manufacturing Practice laid down in Regulation 2 of the current Veterinary Medicines Regulations
Part 2
| 1. MANUFACTURING OPERATIONS |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| 2. IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.1 ] Quality control testing of imported medicinal products |
| [ 2.1.3 ] Chemical/Physical |
Restrictions or remarks:None
Part 3
Nature of non-compliance:
The company failed to operate a compliant GMP quality management system. This was identified during inspection Insp GMP/IMP 46334/14567004-0005. Over two subsequent inspections the company could not demonstrate that all CAPA actions committed to in response to the initial inspection had been implemented, and that the CAPA which had been implemented were effective.
revocation
Withdrawal of current valid GMP certificates:
UK GMP 46334 Insp GMP/IMP 46334/14567004-0006 [H] and UK GMP 46334 Insp GMP/IMP 46334/14567004-0006 [V]
Marketing authorisation value:
Requested variation
Marketing authorisation action :
Marketing authorisation holders should remove the laboratory from applicable authorisations by variation.
The company failed to operate a compliant GMP quality management system. This was identified during inspection Insp GMP/IMP 46334/14567004-0005. Over two subsequent inspections the company could not demonstrate that all CAPA actions committed to in response to the initial inspection had been implemented, and that the CAPA which had been implemented were effective.
Action taken/proposed:
Withdrawal of current valid GMP certificates:
UK GMP 46334 Insp GMP/IMP 46334/14567004-0006 [H] and UK GMP 46334 Insp GMP/IMP 46334/14567004-0006 [V]
Marketing authorisation value:
Marketing authorisation action :
Marketing authorisation holders should remove the laboratory from applicable authorisations by variation.
| 30/06/2023 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |