Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK GMP 35566 Insp GMP 35566/1053695-0001 [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 : BIOAGILYTIX LABS INCORPORATED
 
Site address : BIOAGILYTIX LABS INCORPORATED, 2300 ENGLERT DRIVE, SUITES G-J, DURHAM, 27713, UNITED STATES
 

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area 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 26/06/2014, 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
  [ 1.6 ] Quality control testing
    [ 1.6.4 ] Biological

Any restrictions related to the scope of this certificate:

Restrictions
BuildingRoomLine/equipmentQC TestingProducts
This inspection only covered the CDC testing for one product and the general quality systems on site.
Contact Details
05/08/2014 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential