zip PICs GMP medicines

A zip file containing 78 QMS templates relevant to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) standard for Good Manufacturing Practice

Non-Conformance Management

This SOP describes the procedures and responsibilities for the management of non-conformances and deviations (planned and unplanned). It relates to non-conforming products, materials, processes, procedures (documentation), environment, facility and equipment.

Document Control SOP

This procedure describes the system, provides instructions and identifies responsibilities for control of documents throughout their lifecycle. It includes the preparation, review, authorisation, issue, identification, legibility, distribution, revision and withdrawal of all controlled documents.

Change Control Plan

This SOP lays out the procedures in a facility to carry out any changes to documents, processes, equipment, or suppliers

Validation Master Plan

Describes the process of performing validation of new processes (including equipment) and equipment (including facility upgrades)