Revision of the PIC/S Document PH 4/93 on the Preparation of a Site Master File

GMP News No. 292

GMP News
24 February 2003

Revision of the PIC/S Document PH 4/93 on the Preparation of a Site Master File

In November 2002, PIC/S (Pharmaceutical Inspection Co-Operation Scheme) published a revision of the document on the preparation of a site master file, which had been released in April 1993. The revised document PE 008-1 differs from its predecessor only in few points:

1. Title of the document
The additional phrase " be part of the information requested under article 2 of the Pharmaceutical Inspection Convention" was left out in the title of the revised document. As the Inspection Co-Operation Scheme came into force in November 1995, the reference to the Inspection Convention would not be up to date any more. What is more interesting, however, are the following changes:

2. Point C.5.3: Arrangements for Reprocessing or Rework
This new sub-chapter has been included in the "Production" section, thus taking account of the fact that inspections focus more and more on reprocessing and rework. 

3. Point C.1.7: Number of employees engaged in the quality assurance, production, quality control, storage and distribution
In contrast to its predecessor, the revised document mentions quality assurance in the title of this chapter; in the following text, a clear distinction is made between quality assurance and quality control as two separate departments.

These were the most important changes in the revision of PH 4/93. 

If you would like to read the unabridged PIC/S document, please click here.

Dr Gerhard Becker

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