What Should be Considered During Specification Setting?
When the specifications for the drug substances or drug product are being prepared, The following concepts as per ICH Q6A are important in the development and setting of harmonized specifications. such as, but limited to:
1) Periodic or Skip Testing:
Periodic or skip testing is the performance of specified tests at release on pre-selected batches and/or at predetermined intervals, rather than on a batch-to-batch basis with the understanding that those batches not being tested still must meet all acceptance criteria established for that product. This represents a less than full schedule of testing and should therefore be justified and presented to and approved by the regulatory authority prior to implementation
2) Release vs. Shelf-life Acceptance Criteria
The concept of different acceptance criteria for release vs. shelf-life specifications applies to drug products only; it pertains to the establishment of more restrictive criteria for the release of a drug product than are applied to the shelf-life. in order to provide increased assurance to the applicant that the product will remain within the regulatory acceptance criterion throughout its shelf-life.
Read also:
- Dissolution Specification Setting Procedure
- Do the Retest Date and Expiration Date Mean the Same Thing?
Resource Person: Bashar Assi
