Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK ManA 6180 Insp GMP 6180/88968-0014[V]

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

Part 1
Issued following an inspection in accordance with :

Regulation 5 of the current Veterinary Medicines Regulations

  The competent authority of United Kingdom confirms the following :
The Manufacturer : SYNERGY HEALTH STERILISATION UK LIMITED
 
Site address : SYNERGY HEALTH STERILISATION UK LIMITED, ROYDSDALE WAY, EUROWAY TRADING ESTATE, BRADFORD, BD4 6SE, UNITED KINGDOM
 

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK ManA 6180 in accordance with Regulation 5 of The current Veterinary Medicines Regulations

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 06/09/2022, it is considered that it complies with

  • The principles and guidelines of Good Manufacturing Practice laid down in Regulation 5 of the current Veterinary Medicines Regulations

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
Veterinary Medicinal Products
Operations
  1. MANUFACTURING OPERATIONS
  [ 1.4 ] Other products or manufacturing activity
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
      [ 1.4.2.5 ] Gamma irradiation
Restrictions or Remarks
The scope of this certificate includes both the Bradford Pallet Plant process and the separate Radiation Technology Centre (RTC) process that are performed at this site.

Any restrictions related to the scope of this certificate:

Restrictions
BuildingRoomLine/equipmentQC TestingProducts
Includes both Radiation Technology Centre (RTC) process and Bradford Pallet Plant process that are performed at the site.
Contact Details
03/11/2022 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential