cGMPs mandate the sampling - analysis to be accountability drug product manufacturer;
-
what is the sampling-procedure for pre-dispensed materials (i.e., materials received are exact quantities as required for a finished product batch; and there is no separate dispensing step for the material )
-
for implementation (or justifying to regulatory authorities (specific to EMEA/MHRA).), what are additional controls required for adopting pre-shipment samples and piggyback samples!!!
there are certain guidelines & clarifications on cGMP aspects of sampling from USFDA…
.
[quote]How many containers of each component from each shipment must a firm sample and test to comply with the CGMP requirements for identity testing?
The regulation at 21 CFR 211.84 requires that representative samples of each shipment of each lot shall be collected for testing. Some manufacturers have interpreted the CGMPs to require that each container in a shipment be sampled and tested for the attribute of identity. Testing samples from every container to determine identity may be valuable particularly for components purchased from distributors. (Analytical equipment and methods are readily available that permit rapid, non-destructive identification of material directly in containers in a warehouse area.) The CGMPs permit each drug product manufacturer to make its own decision as to the number of containers to sample, as long as thesampling plan is scientifically sound, leads to representative samples, and complies with the principles established at 21 CFR 211.84(b). An important caveat applies with respect to 21 CFR 211.84: samples are to be taken by the drug product manufacturer from containers after receipt (i.e., pre-shipment samples or so-called “piggyback” samples are generally not acceptable).
[/quote]
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124780.htm
[quote]Sec. 211.84 Testing and approval or rejection of components, drug product containers, and closures.
(c) Samples shall be collected in accordance with the following procedures:
4) If it is necessary to sample a component from the top, middle, and bottom of its container, such sample subdivisions shall not be composited for testing.
[/quote]
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.84