Do You Already Know the PIC/S Document PI 006-1?

GMP News No. 176

GMP News
2 March 2002

 Do You Already Know the PIC/S Document PI 006-1?

At the beginning of 1996 the document PH 1/96 "Principles of Qualification and Validation in Pharmaceutical Manufacture" was published by the Pharmaceutical Inspection Convention (PIC). This document has been the first to give definitions in the field of production on the topics:
  • Validation Master Plan
  • Installation and Operational Qualification
  • Non-sterile Process Validation
  • Cleaning Validation

that were mandatory for the PIC member states.

This document was "put to the test" for two years and then revised according to the experience gathered during the "test phase" and the commentaries by industry and authorities. The revised version came into force on 1 March 1999 under the title PIC/S PR 1/99-1. A revision of the PIC/S document PR 1/99-2 followed, which was mandatory from April 2000. This revision encompassed only the insertion of a copyright note, an alteration in the e-mail address of the editor, and a new page numbering. 

PIC/S PR 1/99 was the basis for Annex 15, which came into force in September 2001.

In autumn last year the PIC/S document PR 1/99-2 was revised again. It was part of the revision that the document was given the new number PI 006-1. This was due to the fact that the PIC/S committee had adopted this document as a "Guidance Document" for inspectors.

What else was changed?

Again, the editor's contact address was altered (new e-mail and internet address). 

The latest changes were included in the document history.

Since the introduction had been modified, both the numbering of the chapters and the page numbering changed.

What has now changed in the introduction?

The text points out that the basic principles of the topic qualification/validation are described in Annex 15.

The document serves as a guideline for the inspectors, but is now also used in the education of inspectors and considered as a helpful tool for the preparation of inspections.

Particular emphasis is given to the fact that on the one hand the document is not mandatory for industry, but on the other hand "industry should consider these recommendations as appropriate." Besides, the text stresses that the document reflects the state of the art.

Which changes do now result from the revision for the practical work? On the whole the influence is small. However, the document's importance has grown considerably due to the new introduction. Especially since many people interested in validation/qualification were disappointed by the contents of Annex 15 because they had expected to get more concrete information. This is why more often again those seeking advice consult the document (that is now titled) PIC/S PI 006-1.

It is surprising that the revision was not better harmonised with the Annex 15. Thus there are still differences between Annex 15 and PIC/S PI 006-1 as regards the definitions of the Performance Qualification (PC). Both texts document the state of the art, in this respect both approaches are practicable and therefore one of them should be selected according to the individual validation project. Another discrepancy lies in the fact that PIC/S PI 006-1 does not contain the requirement of a risk analysis as included in Annex 15.

This means that some questions about how to put the two regulations into the practice of validation and qualification activities remain unanswered.

The following ECA Education Course will help you to find the answers:

Date Title Venue
22-25 April 2002 Pharmaceutical Engineering 
(with Workshops)
Vienna, Austria

This event is recognised within the framework of the ECA Professional Certification Programme. Please click here if you would like to read more about it.

Sven Pommeranz


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