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

GMP News No. 176

GMP News
2 March 2002

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

At the beginning of 1996 the document PH 1/96 "Principlesof Qualification and Validation in Pharmaceutical Manufacture" waspublished by thePharmaceutical Inspection Convention (PIC). This document has been thefirst 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 thetest" for two years and then revised according to the experiencegathered during the "test phase" and the commentaries byindustry and authorities. The revised version came into force on 1 March1999 under the title PIC/S PR 1/99-1. A revision of the PIC/S document PR1/99-2 followed, which was mandatory from April 2000. This revisionencompassed only the insertion of a copyright note, an alteration in thee-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 inSeptember 2001.

In autumn last year the PIC/S document PR 1/99-2 was revised again. Itwas part of the revision that the document was given the new number PI006-1. This was due to the fact that the PIC/S committee had adopted thisdocument as a "Guidance Document" for inspectors.

What else was changed?

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

The latest changes were included in the document history.

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

What has now changed in the introduction?

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

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

Particular emphasis is given to the fact that on the one hand thedocument is not mandatory for industry, but on the other hand "industry should consider theserecommendations asappropriate." Besides, the text stresses that the document reflectsthe 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 importancehas grown considerably due to the new introduction. Especially since many peopleinterested in validation/qualification were disappointed by the contentsof 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 theAnnex 15. Thus there are still differences between Annex 15 and PIC/S PI006-1 as regards the definitions of the Performance Qualification (PC).Both texts document the state of the art, in this respect both approachesare practicable and therefore one of them should be selected according tothe individual validation project. Another discrepancy lies in the factthat PIC/S PI 006-1 does not contain the requirement of a risk analysis asincluded in Annex 15.

This means that some questions about how to put the tworegulations into the practice of validation and qualification activitiesremain unanswered.

Sven Pommeranz



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