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Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK MIA(IMP) 14620 Insp GMP/IMP 14620/11383121-0009[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 : BARTS HEALTH NHS TRUST (PHARMACY CHEMOTHERAPY UNIT 7TH FLOOR)
 
Site address : BARTS HEALTH NHS TRUST (PHARMACY CHEMOTHERAPY UNIT 7TH FLOOR), DEPARTMENT OF PHARMACY- PHARMACY CHEMOTHERAPY UNIT, 7TH FLOOR, KING GEORGE V WING, ST BARTHOLOMEW'S HOSPITAL, WEST SMITHFIELD, LONDON, EC1A 7BE, UNITED KINGDOM
 

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK MIA(IMP) 14620 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 14/06/2021, 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
  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
    [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms)
      [ 1.1.2.1 ] Large volume liquids
  [ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
      [ 1.2.1.5 ] Liquids for external use
      [ 1.2.1.6 ] Liquids for internal use
  [ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
      [ 1.3.1.4 ] Gene therapy products
      [ 1.3.1.8 ] Other biological medicinal products
Monoclonal Antibodies
  [ 1.4 ] Other products or manufacturing activity
    [ 1.4.1 ] Manufacture of:
      [ 1.4.1.3 ] Other
Radiopharmaceuticals/radionuclide generators
  [ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
      [ 1.5.1.5 ] Liquids for external use
      [ 1.5.1.6 ] Liquids for internal use
      [ 1.5.1.11 ] Semi-solids
    [ 1.5.2 ] Secondary packaging
  [ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
17/08/2021 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential

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