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
1. Title of the document
The additional phrase "...to 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
These were the most important changes in the revision of