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Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK GMP 21635 Insp GMP 30937/340471-0007[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 : NOVARTIS SAGLIK, GIDA VE TARIM URUNLERI SAN. VE TIC. A.S.
 
Site address : NOVARTIS SAGLIK, GIDA VE TARIM URUNLERI SAN. VE TIC. A.S., YENISEHIR MAHALLESI, IHLARA VADISI SOKAK NO. 2, PENDIK, ISTANBUL, TR 34912, TURKEY
 

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Part 16 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 01/03/2017, 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
  1. MANUFACTURING OPERATIONS
  [ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
      [ 1.2.1.1 ] Capsules, hard shell
      [ 1.2.1.8 ] Other solid dosage forms
      [ 1.2.1.13 ] Tablets
  [ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
      [ 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
Restrictions or Remarks
Scope of the inspection was limited to non-sterile tablet manufacturing and packaging. This included film coated, sugar coated, sustained release, dispersible and enteric coated tablets.
07/08/2017 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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