Health Canada Equipment Qualification

The sterigenics facility in the us used ethylene oxide sterilization methods for example but alternate sterilization sites may not.

Health canada equipment qualification. Health canada adds that moving a sterilization process to a new facility may include changes to the sterilization process equipment and or cycle parameters. The qualification status of principal equipment and utilities. The studies must include equipment specifications installation qualification iq and operational qualification oq of all major equipment to be.

4 1 5 6 for existing equipment. Further guidance is detailed in health canada s document entitled cleaning validation guidelines gui 0028. Installation qualification for all systems sub systems equipment and monitors and computerized systems is a requirement of the overall validation activity.

Understanding iq oq and pq will set you up for success in transferring your process to a good manufacturing practices gmp facility. Equipment cleaning sanitization studies should address microbiological and endotoxin contamination for those processes where there is a need to reduce total microbiological count or endotoxins in the api or other processes where such. Health canada and fda guidance documents will frequently refer to iq oq and pq where requirements for equipment are outlined.

Manufacturers will be required to submit valid mdsap certificates no later than 01 january 2019 to maintain their mdl. Solid dosage forms liquid dosage forms sterile products where scientifically justified. However health canada is participating in the medical device single audit program mdsap.

Studies which establish with confidence that the process equipment and ancillary systems are capable of consistently operating within established limits and tolerances. The adequacy of any previous corrective actions related to product process or equipment. Objectives facilities and equipment cgmp highlights aseptic manufacturing facility equipment qualification cleaning validation.

In accordance with health canada s announced mdsap transition plan cmdcas certificates will no longer be accepted after 31 december 2018. 4 1 5 5 for new equipment. For existing equipment subject to concurrent or retrospective validation approaches installation qualification requires defining the existing equipment design and installation parameters from records and direct assessment.