Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK MIA(IMP) 15059 Insp IMP 15059/27971-0017[I]

Certificate of GMP Compliance Of A Manufacturer(1),(2)

Part 1
Issued following an inspection in accordance with :

Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)

  The competent authority of United Kingdom confirms the following :
The Manufacturer : CELERION GB LIMITED
 
Site address : CELERION GB LIMITED, 22-24 LISBURN ROAD, BELFAST, BT9 6AD, UNITED KINGDOM
 

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK MIA(IMP) 15059 in accordance with Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 01/03/2021, 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.
Part 2
Human Investigational Medicinal Products
Operations
  1. MANUFACTURING OPERATIONS
  [ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)
      [ 1.1.1.1 ] Large volume liquids
      [ 1.1.1.4 ] Small volume liquids
    [ 1.1.3 ] Batch certification
  [ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
      [ 1.2.1.1 ] Capsules, hard shell
      [ 1.2.1.6 ] Liquids for internal use
    [ 1.2.2 ] Batch certification
  [ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
      [ 1.3.1.1 ] Blood products
      [ 1.3.1.2 ] Immunological products
      [ 1.3.1.3 ] Cell therapy products
      [ 1.3.1.4 ] Gene therapy products
      [ 1.3.1.5 ] Biotechnology products
      [ 1.3.1.6 ] Human or animal extracted products
  [ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
      [ 1.5.1.1 ] Capsules, hard shell
      [ 1.5.1.2 ] Capsules, soft shell
      [ 1.5.1.3 ] Chewing gums
      [ 1.5.1.4 ] Impregnated matrices
      [ 1.5.1.5 ] Liquids for external use
      [ 1.5.1.6 ] Liquids for internal use
      [ 1.5.1.8 ] Other solid dosage forms
      [ 1.5.1.11 ] Semi-solids
      [ 1.5.1.12 ] Suppositories
      [ 1.5.1.13 ] Tablets
      [ 1.5.1.14 ] Transdermal patches
      [ 1.5.1.17 ] Other non-sterile medicinal products
Pessaries and vaginal rings
    [ 1.5.2 ] Secondary packaging
  [ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical
  2. IMPORTATION OF MEDICINAL PRODUCTS
  [ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.3 ] Chemical/Physical
  [ 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
  [ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing
Restrictions or Remarks
This certificate is issued based on a remote inspection of GMP compliance during COVID-19 travel restrictions. A risk-based site inspection programme remains in force.

Aseptic processing is restricted to preparatory manipulations for already sterile products.

Testing activities limited to physical testing only, no GMP analytical testing conducted on site.

Any restrictions related to the scope of this certificate:

Restrictions
BuildingRoomLine/equipmentQC TestingProducts
Testing activities limited to physical testing only, no GMP analytical testing conducted on site.
Contact Details
24/05/2021 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential