Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK MIA(IMP) 35718 Insp IMP 35718/8697-0025[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 : QUOTIENT SCIENCES LIMITED
 
Site address : QUOTIENT SCIENCES LIMITED, TRENT HOUSE/SHERWOOD HOUSE/LIME HOUSE, MERE WAY, RUDDINGTON FIELDS, RUDDINGTON, NOTTINGHAM, NG11 6JS, UNITED KINGDOM
 

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK MIA(IMP) 35718 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 04/02/2022, 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
Operations
  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
      [ 1.1.1.4 ] Small volume liquids
        [ 1.1.1.6 ] Other aseptically prepared products
Any products listed in section 1.1 may be radiolabelled and contain antibiotics, cytotoxics, biotech
    [ 1.1.3 ] Batch certification
  [ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
      [ 1.2.1.1 ] Capsules, hard shell
      [ 1.2.1.5 ] Liquids for external use
      [ 1.2.1.6 ] Liquids for internal use
      [ 1.2.1.8 ] Other solid dosage forms
      [ 1.2.1.9 ] Pressurised preparations
      [ 1.2.1.11 ] Semi-solids
      [ 1.2.1.12 ] Suppositories
      [ 1.2.1.13 ] Tablets
        [ 1.2.1.17 ] Other non-sterile medicinal products
Any products listed in 1.2 may be radiolabelled and contain antibiotics, cytotoxics, biotechnology,
    [ 1.2.2 ] Batch certification
  [ 1.3 ] Biological investigational medicinal products
    [ 1.3.1 ] Biological medicinal products
      [ 1.3.1.5 ] Biotechnology products
        [ 1.3.1.8 ] Other biological medicinal products
Radiolabelling and/or aseptic assembly of pre-formulated biologicals. Any of the products listed in
  [ 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
    [ 1.5.1 ] Primary packaging
      [ 1.5.1.1 ] Capsules, hard shell
      [ 1.5.1.5 ] Liquids for external use
      [ 1.5.1.6 ] Liquids for internal use
      [ 1.5.1.8 ] Other solid dosage forms
      [ 1.5.1.9 ] Pressurised preparations
      [ 1.5.1.11 ] Semi-solids
      [ 1.5.1.12 ] Suppositories
      [ 1.5.1.13 ] Tablets
    [ 1.5.2 ] Secondary packaging
  [ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
  2. IMPORTATION OF MEDICINAL PRODUCTS
  [ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.2 ] Microbiological: non-sterility
    [ 2.1.3 ] Chemical/Physical
  [ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.1 ] Sterile Products
      [ 2.2.1.1 ] Aseptically prepared
    [ 2.2.2 ] Non-sterile products
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.8 ] Other biological medicinal products
Radiolabelling and/or aseptic assembly of pre-formulated biologicals. Any of the products listed in
  [ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing
    [ 2.3.4 ] Other
Importation of QP-certified IMPs from a country on the approved country for import list
Restrictions or Remarks
This was a focused remote inspection following a variation to add import oversight for IMP from listed countries.
GMP manufacturing activities performed in Trent House; QC activities performed in Lime House.
Contact Details
14/02/2022 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential