Medicines and Healthcare products Regulatory Agency

CERTIFICATE NUMBER : UK API 17454 Insp GMP 17454/9491-0001

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 : SOURCETECH QUIMICA LIMITADA
 
Site address : SOURCETECH QUIMICA LIMITADA, RUA SUICA 3430, PINDAMONHANGABA-SP, BR-12403 610, BRAZIL
 

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 16/10/2012, it is considered that it complies with:

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:

  • [2000008004] PILOCARPINE HYDROCHLORIDE
  • [2000008003] PILOCARPINE NITRATE
Active Substances
3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
PILOCARPINE HYDROCHLORIDE
3.2Processing Activities of Active Substance from Natural Sources
3.2.1  Plant Source Extraction

3.2.5  Modification of extracted substance

3.2.6  Purification of extracted substance

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

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing (excluding sterility testing)

PILOCARPINE NITRATE
3.2Processing Activities of Active Substance from Natural Sources
3.2.1  Plant Source Extraction

3.2.5  Modification of extracted substance

3.2.6  Purification of extracted substance

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

3.6Quality Control Testing
3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing (excluding sterility testing)

Contact Details
12/02/2013 Name and signature of the authorised person of the Competent Authority of United Kingdom
Confidential
Medicines and Healthcare products Regulatory Agency
Tel : Confidential