A pharmaceutical manufacturer outsources microbiological tes…
A pharmaceutical manufacturer outsources microbiological testing of finished products to an external laboratory. No technical agreement is available describing responsibilities for sample handling, testing, investigations, or data reporting. According to GMP principles, what is the primary concern?
Read DetailsDuring supplier qualification activities, a pharmaceutical m…
During supplier qualification activities, a pharmaceutical manufacturer reviews several certificates of analysis received from an API supplier over a six-month period. The reported analytical results are identical across multiple batches to the same number of decimal places. According to PIC/S GMP data integrity principles, what is the most appropriate concern?
Read DetailsA pharmaceutical company outsources stability testing to an…
A pharmaceutical company outsources stability testing to an external laboratory. The technical agreement specifies testing responsibilities but does not define responsibilities for investigation of out-of-specification (OOS) results. Why is this considered inadequate?
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