培训材料-Q7A-2.pptVIP

Sampling and Testing of Incoming Production Materials At one test should be conducted to verify the identity of incoming materials. -Exception: Dangerous or highly toxic materials, processing aids, or internally transfered materials do not need to be tested if a Certificate of Analysis is obtained; specs o.k.! -Non-testing should be justified and documented A suppliers CofA can be used instead of other testing if the supplier has been evaluated/audited by QU! Supplier approval should include the proof that material consisitently can meet the specs. Before reducing testing at least three batches should undergo full testing against the specs. At appropriate intervalls full testing should be conducted. Sampling Samples should be representative; SOP should define --number of containers , which part of container --amount of material to be taken A sampling plan should be set based on criticality of the material, variability, past quality history, amount needed for analysis! Contamination during sampling should be avoided (defined location, sampling booth). Containers to be sampled should be carefully opened and reclosed and marked as ?sampled“. 8. Production and In Process Controls Weighing and measuring devices should have a suitable accuracy for their intended use. Critical weighing, measuring, subdividing should be witnessed or equivalent control to be used (AM: which?) Actual yields should be compared with expected yields. The processing status of major equipment should be indicated (status label, computer control systems, etc.) Time limits if specified should be met. Intermediates held for further processing should be stored under defined appropriate conditions! In-process Sampling and Controls IPCs should be established to monitor the progress and control the performance of the processing step. Ranges! Critical IPCs should be approved by the QU. Qualification/training of production personnel performing the IPCs should be documented. SOPs how to do