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Validation - Leveraging for Compliance [215 kb]

Presentation to ISPE Australasia Conference 2007.
Presentation outline: Current validation practice, Enhanced qualification management, Knowledge from PQ, Enhanced process monitoring.
[Ref: M Parlane, New Wayz Consulting Limited]

Annex 1 - Manufacture of Sterile Medicinal Products (Sep 2003) [146 kb]

Located in Volume 4 - Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice.
[Ref: Eudralex Collection. The Rules Governing Medicinal Products in the European Union.]

Classification of Cleanrooms [165 kb]

This paper describes the classification of clean rooms comparing a number of international standards, as well as discussing classifications in common in New Zealand.
[Ref: M Parlane, New Wayz Consulting Limited]

Equipment Qualification and Process Validation in Pharmaceutical Manufacture [225 kb]

This document comprises the individual recommendations of four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows:

• Validation Master Plan
• Installation and Operational Qualification
• Non-Sterile Process Validation
• Cleaning Validation

The four recommendations comprising the document define general priniciples pertaining to each of the topics.
[Ref: PIC/S PI 006-02 (1 July 2004)]

Site Master Files [196 kb]

PIC/S Explanatory Notes for Industry on the preparation of a Site Master File.
[Ref: PIC/S PE 008-2 (1 July 2004)]

A Site Master File (SMF) is a document prepared by a manufacturer to provide specific, factual information about the production and control of manufacturing operations at the named site, and any closely integrated operations in adjacent and nearby buildings.