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 4543 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 12/09/2022, 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 |
| [ 1.1 ] 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 |
| [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) |
| [ 1.1.2.3 ] Small volume liquids |
| [ 1.1.3 ] Batch certification |
| [ 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 products Nasal Sprays |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.2 ] Immunological products |
| [ 1.3.1.5 ] Biotechnology products |
| [ 1.3.1.6 ] Human or animal extracted products |
| [ 1.3.1.8 ] Other biological medicinal productsmanufacture of products based on botanical extracts and hormones |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.5 ] Biotechnology products |
| [ 1.3.2.6 ] Human or animal extracted products |
| [ 1.3.2.8 ] Other biological medicinal productsmanufacture of products based on botanical extracts and hormones |
| [ 1.4 ] Other products or manufacturing activity |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.4 ] Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) |
| [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: |
| [ 1.4.2.1 ] Filtration |
| [ 1.4.2.2 ] Dry heat |
| [ 1.4.2.3 ] Moist heat |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.17 ] Other non-sterile medicinal productsNasal spray |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.1 ] Microbiological: sterility |
| [ 1.6.2 ] Microbiological: non-sterility |
| [ 1.6.3 ] Chemical/Physical |
| [ 1.6.4 ] Biological |
| 2. IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.1 ] Quality control testing of imported medicinal products |
| [ 2.1.1 ] Microbiological: sterility |
| [ 2.1.2 ] Microbiological: non-sterility |
| [ 2.1.3 ] Chemical/Physical |
| [ 2.1.4 ] Biological |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.1 ] Sterile Products |
| [ 2.2.1.1 ] Aseptically prepared |
| [ 2.2.1.2 ] Terminally sterilised |
| [ 2.2.2 ] Non-sterile products |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.5 ] Biotechnology products |
| [ 2.2.3.6 ] Human or animal extracted products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
| 24/02/2023 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |