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Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK MIA(IMP) 40211 Insp IMP 40211/405290-0015[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 : SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED
 
Site address : SYMBIOSIS PHARMACEUTICAL SERVICES LIMITED, SCION HOUSE, STIRLING UNIVERSITY INNOVATION PARK, STIRLING, FK9 4NF, UNITED KINGDOM
 

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK MIA(IMP) 40211 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 17/08/2021, 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)
      [ 1.1.1.2 ] Lyophilisates
Cytotoxics
      [ 1.1.1.4 ] Small volume liquids
Cytotoxics
      [ 1.1.1.6 ] Other aseptically prepared products
Suspensions
Cytotoxics
  [ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
      [ 1.2.1.17 ] Other non-sterile medicinal products
Lyophilisation of non-sterile active ingredients / excipients for use as starting materials in solid oral dosage manufacturing elsewhere
Cytotoxics
  [ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
      [ 1.3.1.2 ] Immunological products
      [ 1.3.1.4 ] Gene therapy products
      [ 1.3.1.5 ] Biotechnology products
              [ 1.3.1.8 ] Other biological medicinal products
Plasmid, DNA, RNA. peptides. proteins and antibodies products. This list is only indicative of the product handled.
Cytotoxics
  [ 1.4 ] Other products or manufacturing activity
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
      [ 1.4.2.1 ] Filtration
  [ 1.5 ] Packaging
    [ 1.5.2 ] Secondary packaging
  2. IMPORTATION OF MEDICINAL PRODUCTS
  [ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.3 ] Biological medicinal products
      [ 2.2.3.4 ] Gene therapy products
  [ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing
Restrictions or Remarks
MIA(IMP) packaging operations restricted to open label, non-randomised activities.
14/07/2022 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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