Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK API 18788 Insp GMP 18788/11325-0002 [V]

Certificate of GMP Compliance Of A Manufacturer(1),(2)

Part 1
Issued following an inspection in accordance with :

Regulation 5 of the current Veterinary Medicines Regulations

  The competent authority of United Kingdom confirms the following :
The Manufacturer : ROCHE CAROLINA, INCORPORATED
 
Site address : ROCHE CAROLINA, INCORPORATED, 6173 EAST OLD MARION HIGHWAY, FLORENCE, 29506-9330, UNITED STATES
 

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 27/01/2014, 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
Veterinary Medicinal Products

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

  • [1000011433] CAPECITABINE
  • [2000006801] OSELTAMIVIR PHOSPHATE
  • [1000002752] ORLISTAT
  • [2000006980] VALGANCICLOVIR HYDROCHLORIDE
Active Substances
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
CAPECITABINE
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.3  Salt Formation/Purification steps (eg. Crystallisation)
Crystallisation
3.5General Finishing Steps
3.5.1  Physical Processing Steps
Sieving
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

OSELTAMIVIR PHOSPHATE
3.1Manufacture of Active Substance by Chemical Synthesis
3.1.1  Manufacture Of Active Substance Intermediates

3.1.3  Salt Formation/Purification steps (eg. Crystallisation)
Crystallisation
3.5General Finishing Steps
3.5.1  Physical Processing Steps
Delumping using a comil
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

ORLISTAT
3.5General Finishing Steps
3.5.1  Physical Processing Steps
Milling
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

VALGANCICLOVIR HYDROCHLORIDE
3.5General Finishing Steps
3.5.2  Primary Packaging

3.5.3  Secondary Packaging

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

Restrictions or Remarks
Excludes the Development/Pilot Plan Building 800
Contact Details
10/04/2014 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential