By Leonard Steinborn
Quantity 1 of this two-part package deal offers a whole set of checklists for inner and agreement machine and drug brands and builders, agreement software program builders, and providers of chemical, revealed fabric, digital part, and common offers. it is usually a simulated QSIT audit, and a new-product marketplace release. All of those are referenced to the proper appropriate FDA laws, EC and IPEC directions, and ISO/BSI criteria. The textual content additionally explains numerous audit varieties, do's and don'ts for auditors, and information for audit training, functionality, end, document derivation, and stick to up actions. A CD-ROM packaged with the booklet includes all the checklists in a customizable digital layout.
Read or Download GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers, Sixth Edition, (Volume 1 - With Checklis PDF
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