GB/T 28671-2012Guidelines for pharmaceutical machinery validation (English PDF)

3.1 Pharmaceutical equipment verification

Pharmaceutical equipment design validation, installation, OQ and performance qualification, proven pharmaceutical equipment to achieve the expected result of a

A series of activities.

3.2 User needs standard userrequirementspecification

While meeting the relevant regulations and standards, consumer equipment to meet the requirements of the target document production, inspection and management of the conditions required.

3.3 Authentication scheme validationprotocol

It explains how to verify and validate the eligibility criteria to determine the written plan, which includes verification of objectives, contents, methods and acceptance criteria.

3.4 Design validation

Pre-review of pharmaceutical equipment, pharmaceutical equipment designed to meet the proof of intended use, "Good Manufacturing Practice (Revised 2010

Order) "and Appendix, standard user needs and pharmaceutical equipment product standards.

3.5 Installation Qualification

Pharmaceutical equipment after installation of various systems checks, proof of pharmaceutical equipment manufacture and installation of the required standard.

3.6 OQ operationalqualification

Various operational tests to verify the equipment or associated with the pharmaceutical system reaches the set requirements be proved run pharmaceutical equipment operator

Co-design standards.