Certified B10 / TS 4.1 laboratories

GMP+ certified companies are required to have their analyses carried out at by Certified Laboratories. It concerns laboratories with a GMP+ (or equivalent) certificate. It is important that companies - in selecting a laboratory for carrying out analyses - check for what operations and associated matrix laboratories are certified.

All GMP+10 / TS 4.1 Certified Laboratories can be found in the GMP+ Company Database. For an overview of all Certified Laboratories and their use the filter 'scope' and select 'Laboratory Testing or Registered Laboratory'.

Operation list

GMP+ B10 / TS 4.1 Laboratory analysis specifies the requirements for a quality assurance system, allowing a laboratory to assure that the results of the analyses in the context of the GMP+ FSA module, are sufficiently reliable.

Certification takes place per type of operation, combined with the analysis method and matrix, documented on an annex with the certificate. An operation is that which can be analyzed by means of an analysis method. Insight into this information is given to the companies. 

The operation lists are available in the GMP+ company database in addition to the listing of Certified Laboratories.