CGMP Manufacturing Practice Regulations for Finished Pharmaceuticals

Released – September 8, 2008
Effective – December 8, 2008

Amendments have been made to the CGMP for finished pharmaceuticals. Included in the three areas targeted for change is Aseptic Processing, specifically §211.113(b), §211.67(a), §211.84(d)(6), and §211.110(a).

  1. §211.113(b); requires that procedures for prevention of microbial contamination must include validation of all aseptic processes as well as any sterilization process.
  2. §211.67(a); requires a routine schedule for cleaning & maintenance of equipment and utensils as well as addressing the appropriateness of the need for sanitization and/or sterilization
  3. §211.84(d)(6); each lot of a component, drug product container or closure that has the possibility of microbial contamination that may affect the end product must undergo microbiological tests
  4. §211.94(c); depyrogenation processes of drug product containers & closures must be validated
  5. §211.110(a); bioburden testing of in-process materials as a part of the in-process control procedures has been added

Geneva Labs is equipped to assist you with these newly required validations and/or testing regimens. Please contact our customer service department for capability and cost.