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Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK MIA(IMP) 32917 Insp GMP/IMP 32917/16466470-0004[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 : SARTORIUS STEDIM BIOOUTSOURCE LIMITED
 
Site address : SARTORIUS STEDIM BIOOUTSOURCE LIMITED, 2ND FLOOR, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, UNITED KINGDOM
 

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK MIA(IMP) 32917 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 19/12/2024, 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
  [ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
      [ 1.3.1.8 ] Other biological medicinal products
Mammalian Cell banks - MCB and WCB
    [ 1.3.2 ] Batch certification
      [ 1.3.2.8 ] Other biological medicinal products
Mammalian Cell banks - MCB and WCB
  [ 1.6 ] Quality control testing
    [ 1.6.1 ] Microbiological: sterility
    [ 1.6.2 ] Microbiological: non-sterility
  2. IMPORTATION OF MEDICINAL PRODUCTS
  [ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.1 ] Microbiological: sterility
    [ 2.1.2 ] Microbiological: non-sterility
Restrictions or Remarks
This certificate is issued based on a desk-based assessment of GMP compliance information provided by the manufacturer. This certificate should be used in combination with the relevant authorisation/registration. A risk-based site inspection programme remains in force.
19/12/2024 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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