Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK API 4 Insp GMP/GDP 4/15159-0034

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 : GLAXO OPERATIONS UK LTD (WARE) T\A GLAXO WELLCOME OPERATIONS
 
Site address : GLAXO OPERATIONS UK LTD (WARE) T\A GLAXO WELLCOME OPERATIONS, PRIORY STREET, WARE, SG12 0DJ, UNITED KINGDOM
 

Is an active substance manufacturer that has been inspected in accordance with Regulation 327 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 03/12/2024, it is considered that it complies with

  • The principles of GMP for active substances referred to in Regulation B17 and C17 of the Human Medicines Regulations 2012 (SI 2012/1916)

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

Manufacture of active substance. Names of substances subject to inspection:

  • [4000014056] DOLUTEGRAVIR SODIUM
  • [2000014516] FLUTICASONE FUROATE
  • [4000013535] VILANTEROL TRIFENATATE
  • [2000008220] FLUTICASONE PROPIONATE
  • [4000014045] UMECLIDINIUM BROMIDE
  • [2000008392] SALMETEROL XINAFOATE
  • [2000017021] CABOTEGRAVIR SODIUM
Active Substances
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
DOLUTEGRAVIR SODIUM
3.5General Finishing Steps
3.5.1  Physical Processing Steps
Micronisation for GW Manufacturing and Shanghai Desano Chemical
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing (excluding sterility testing)

FLUTICASONE FUROATE
3.5General Finishing Steps
3.5.1  Physical Processing Steps
Micronisation
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing (excluding sterility testing)

VILANTEROL TRIFENATATE
3.5General Finishing Steps
3.5.1  Physical Processing Steps
Micronisation
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing (excluding sterility testing)

FLUTICASONE PROPIONATE
3.5General Finishing Steps
3.5.1  Physical Processing Steps
Micronisation
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing (excluding sterility testing)

UMECLIDINIUM BROMIDE
3.5General Finishing Steps
3.5.1  Physical Processing Steps
Micronisation
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing (excluding sterility testing)

SALMETEROL XINAFOATE
3.5General Finishing Steps
3.5.1  Physical Processing Steps
Micronisation
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing (excluding sterility testing)

CABOTEGRAVIR SODIUM
3.5General Finishing Steps
3.5.1  Physical Processing Steps
Micronisation
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing (excluding sterility testing)

Any restrictions related to the scope of this certificate:

Restrictions
BuildingRoomLine/equipmentQC TestingProducts
The GMP certificate is restricted to specifically reflect the buildings that have been inspected by the MHRA for the manufacture and testing of medicinal products: A, M, N10, N12, P, S Building (S1 and S2), U2, U3, V, V1, Z1.
Contact Details
28/01/2025 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential