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REQUALIFICATIONS

A sterilization process for a defined product has to be requalified periodically.

The intervals at which requalification is carried out is determined on the basis of your risk assessment and must, if required, be justified to the monitoring authorities.

An interim requalification may become necessary for other reasons even though an interval has already been set for the requalification. For example, there is a requirement under EN ISO 17665-1 and the IFS Food 6 that any change must be evaluated in terms of its effects on the effectiveness of the sterilization process. Such an evaluation may necessitate a premature requalification. For example, hard and software changes, a change to a process parameter or changes to the loading configuration or a change of packaging.

If you do not requalify a process based on your risk assessment after one of the above changes has occurred and any instances of non-sterility occur, you as the operator will have to account for this to the monitoring authorities.

(11.4. EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 15: Qualification and Validation) (Contains Nonbinding Recommendations FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice)

Processes taking place in production, laboratory studies or waste disposal facilities and falling within the scope of GLP or GMP guidelines must be revalidated at regular intervals.

Any change must be evaluated in terms of its effects on the effectiveness of the sterilization process and may necessitate a requalification.

We would be glad to advise you about this and carry out the requalification/revalidation of your processes for you.

 

 

 

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