Can we consider skip testing for UOD & Dissolution? If its acceptable, what will be the evaluation criteria ?
[Product is solid oral dosage form; immediate release, approx 6% API in total product composition. Consider the product is launched, validated, successfull commercial batches are running]
I haven;t certainly heard anything about the same in drug product and that too for a product that too for a test parameter which is official in monograph…
The protocol depends on comprehensive evaluation product specific requirement. System & Process has to demonstrate superior control to meet the specifications.
(process - capability - consistency - predictability )
(system - define a criteria for identifying & evaluating the feasibility of skip testing, define the roll back procedure, further, it has to closely monitor the implementation )
Here are couple of references for herbal drug products and vet.drug products
2.4. Periodic/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. This represents a less than full schedule of
testing and should therefore be justified and presented to the regulatory authority prior to implementation.
This concept may be applicable to, for example, dissolution, residual solvents, and microbiological
testing, e.g., for solid oral dosage forms. This concept may therefore sometimes be implemented postapproval
in accordance with GMP and approval by the Regulatory Authority.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm134966.htm
2.1 Periodic or Skip Testing
Periodic or skip testing is the performance of specified tests at release on preselected batches and/or at predetermined intervals, rather than on a batch-by-batch basis, with the understanding that those batches not being tested still 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. This concept may be applicable to, for example, residual solvents and microbiological testing for solid oral dosage forms. It is recognized that only limited data may be available at the time of submission of an application (see section 2.5). This concept should therefore generally be implemented postapproval. When tested, any failure to meet acceptance criteria established for the periodic test should be handled by proper notification of the appropriate regulatory authority(ies). If these data demonstrate a need to restore routine testing, then batch-
by-batch release testing should be reinstated.