An effective planning is carried out for product realization. In planning these or the service delivery processes, the company determines the following:
Requirements for the product.
The need to establish processes, documents, and provide resources specific to the product
Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance.
QSP for Stability Testing QC/QSP/005-011
QSP for Sieving PRD/QSP/001-010
Work Instructions for Batch Manufacturing PRD/WI/001-011
Records needed to provide the evidence that the product realization/service delivery processes and resulting product fulfil requirements.
Quality Plans are prepared for products, which describe the sequence of realization processes including: