Medicines and Healthcare products Regulatory Agency
Report No : UK GMP 27485 Insp GMP 27485/992430-0002
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
18/11/2024
, 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 :
ZHEJIANG MEDICINES COMPANY LTD
Site address :
ZHEJIANG MEDICINES COMPANY LTD, XINCHANG PHARMACEUTICAL FACTORY, 98 EAST XINCHANG DADAO ROAD, XINCHANG, ZHEJIANG PROVINCE, CN-312 500, CHINA
- 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 |
Restrictions or remarks:The scope of this statement of non-compliance is limited to the sterile medicinal products, manufactured within workshop 117, in building 3208.
Part 3
Nature of non-compliance:
The inspection identified 2 critical findings; the first regarding sterility assurance and contamination controls, and the second regarding the validity and suitability of reported data. 1. The controls in place were such that they posed a significant risk of contaminating sterile medicinal products. 2. Reported data could not be relied upon and resulted in (but was not limited to) contaminated equipment being used with potential to contaminate the sterile products being manufactured.
Withdrawal of current valid GMP certificates:
Not applicable – The site is not currently authorised to manufacture sterile medicinal products. The critical findings are attributed to the initial site inspection, based on an application made for the site to manufacture sterile medicinal products. The marketing authorisation applicant, post inspection, has withdrawn the application.
Marketing authorisation action :
Not applicable – The marketing authorisation applicant, post inspection, has withdrawn the application.
Recall of batches:
Not applicable – no batches have been released. Site is not authorised to manufacture sterile medicinal products.
The inspection identified 2 critical findings; the first regarding sterility assurance and contamination controls, and the second regarding the validity and suitability of reported data. 1. The controls in place were such that they posed a significant risk of contaminating sterile medicinal products. 2. Reported data could not be relied upon and resulted in (but was not limited to) contaminated equipment being used with potential to contaminate the sterile products being manufactured.
Reason:
Not applicable – The site is not currently authorised to manufacture sterile medicinal products. The critical findings are attributed to the initial site inspection, based on an application made for the site to manufacture sterile medicinal products. The marketing authorisation applicant, post inspection, has withdrawn the application.
Withdrawal of current valid GMP certificates:
Not applicable – The site is not currently authorised to manufacture sterile medicinal products. The critical findings are attributed to the initial site inspection, based on an application made for the site to manufacture sterile medicinal products. The marketing authorisation applicant, post inspection, has withdrawn the application.
Marketing authorisation action :
Not applicable – The marketing authorisation applicant, post inspection, has withdrawn the application.
Recall of batches:
Not applicable – no batches have been released. Site is not authorised to manufacture sterile medicinal products.
| 02/05/2025 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |