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INCOMING MATERIALS Receiving: QC samples every lot of raw material (including purchased tablets, capsules, etc.) The total number of containers received determines the number of samples drawn. QC samples using a square root and 1 sampling scheme. RAW MATERIAL TESTING: Every product is tested to some degree each time it is received. The testing includes physical, chemical, and where applicable, microbiological evaluation. Materials are released for use once the testing is successfully completed and a C. of A. from the vendor is received. A sample is retained for future reference.
QC conducts routine inspections each shift while coating is being done. A sample of product from each shift is submitted to QC for testing. This is primarily for disintegration since everything else was previously tested on the uncoated tablet. QC releases the tablets before use by operations. A sample is retained for future reference. QC inspects all runs for finished product appearance and fill/count; QC releases the finished product before placing into stock locations. A sample is retained for future reference.
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