Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK GMP 4737 Insp GMP 4737/15674-0011[H]

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

Part 1
Issued following an inspection in accordance with :

Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)

  The competent authority of United Kingdom confirms the following :
The Manufacturer : JUBILANT HOLLISTERSTIER LLC
 
Site address : JUBILANT HOLLISTERSTIER LLC, 3525 NORTH REGAL STREET, SPOKANE, 99207, UNITED STATES
 

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Regulation 327 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 13/03/2017, 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 Medicinal Products
Operations
  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
  [ 1.3 ] Biological medicinal products
    [ 1.3.1 ] Biological medicinal products
      [ 1.3.1.5 ] Biotechnology products
  [ 1.4 ] Other products or manufacturing activity
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
      [ 1.4.2.1 ] Filtration
      [ 1.4.2.3 ] Moist heat
  [ 1.5 ] Packaging
    [ 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

Any restrictions related to the scope of this certificate:

Restrictions
BuildingRoomLine/equipmentQC TestingProducts
The inspection covered sterile manufacturing and packaging activities on SVP 01 and SVP02 filling lines and all other support activities on site. The off-site warehouse, Building 101/102 at N. Sullivan Road was also inspected..
Contact Details
18/09/2017 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential