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 under the national inspection programme in connection with manufacturing authorisation no. UK MIA 10592 in accordance with Regulation 17 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 14/12/2020, 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) |
| [ 1.2.1.17 ] Other non-sterile medicinal productsActive intermediate Potassium Clavulanate/ Amoxicillin Trihydrate 1:1 non sterile mix, Blending of A |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
Any restrictions related to the scope of this certificate:
| Building | Room | Line/equipment | QC Testing | Products |
|---|---|---|---|---|
| Intermediate tBA Potassium Clavulanate (Neat) Potassium Clavulanate / Silicon Dioxide blend Potassium Clavulanate / Microcrystalline Cellulose blend Potassium Clavulanate / Amoxicillin blend The manufacture of 6-APA was not included in the scope of the inspection. |
| 16/02/2021 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |