Medicines and Healthcare products Regulatory Agency
Report No : Insp GMP 51747/18953344-0001 NCR
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
27/03/2023
, 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)
The Manufacturer :
Genovior Biotech Corporation
Site address :
Genovior Biotech Corporation, Floors 4 & 5 (5F:50-9, 5F:50-8, 4F:50-3), No.50 Keyan Rd, Zhunan Township, Miaoli County, 35053, TAIWAN
- The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17(3) of the Human Medicines Regulations 2012 (as amended)
Part 2
| 1. MANUFACTURING OPERATIONS |
| [ 1.1 ] Sterile Products |
| [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
| [ 1.1.1.2 ] Lyophilisates |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
Restrictions or remarks:The scope of this statement of non-compliance is limited to Sterile medicinal Oncology products manufactured on the 5th Floor of the No.50 Kenyan Road facility.
Part 3
Nature of non-compliance:
The inspection identified a critical finding regarding sterility assurance of product. The controls in place were such that there was a significant risk that product may not be sterile and that this would not be detected due to lack of robust and repeatable aseptic and sterilisation processes. A second critical finding was identified related to contamination and degradation controls.
Withdrawal of current valid GMP certificates:
N/a – none issued for EU GMP.
Marketing authorisation action :
The UK MAA has been withdrawn by the applicant.
Recall of batches:
No batches have been supplied to the UK or EU
Prohibition of supply:
No batches to be supplied to EU markets whilst this statement of non-compliance remains in force.
The inspection identified a critical finding regarding sterility assurance of product. The controls in place were such that there was a significant risk that product may not be sterile and that this would not be detected due to lack of robust and repeatable aseptic and sterilisation processes. A second critical finding was identified related to contamination and degradation controls.
Withdrawal of current valid GMP certificates:
N/a – none issued for EU GMP.
Marketing authorisation action :
The UK MAA has been withdrawn by the applicant.
Recall of batches:
No batches have been supplied to the UK or EU
Prohibition of supply:
No batches to be supplied to EU markets whilst this statement of non-compliance remains in force.
| 30/08/2023 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |