Medicines and Healthcare products Regulatory Agency
Certificate of GMP Compliance Of A Manufacturer(1),(2)
Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)
The competent authority of United Kingdom confirms the following :Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Part 16 of The Human Medicines Regulations 2012 (SI 2012/1916)
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 19/09/2016, it is considered that it complies with
- The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17 of the Human Medicines Regulations 2012 (as amended)
This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. This certificate is valid only when presented with all pages and both Parts 1 and 2. The authenticity of this certificate may be verified in MHRA-GMDP. If it does not appear, please contact the issuing authority.
- (1) Guidance on the interpretation of this template can be found in the Help menu of MHRA-GMDP database.
- (2) These requirements fulfil the GMP recommendations of WHO.
| 1. MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.13 ] Tablets |
| [ 1.6 ] Quality control testing |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
Certificate applies to Plant I (Beta lactams) and Plant II (non beta lactams).
In Plant II only blister packaging line 3 and bulk/bottle packaging line 2 are included in the scope of this certificate
In Plant I only blister packaging line 2 is included in the scope of this certificate
This updated certificate is based on an inspection carried out in September 2016 - see front page of GMP certificate for details.
Any restrictions related to the scope of this certificate:
| Building | Room | Line/equipment | QC Testing | Products |
|---|---|---|---|---|
| Certificate applies to Plant I (Beta lactams) and Plant II (non beta lactams) | In Plant II only blister packaging line 3 and bulk/bottle packaging line 2 are included in the scope of this certificate In Plant I only blister packaging line 2 is included in the scope of this certificate This updated certificate is based on an inspection carried out in September 2016 - see front page of GMP certificate for details. |
| 29/01/2021 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |