Quality Risk Assessment

New draft PIC/S Annex 1 – Part 5 of 8

Parts 5 & 6 of the blog series on the draft revision of Annex 1 looks at Chapter 8 (Production & Specific Technologies). The chapter has been separated into two blog posts due to size, as it is by far the longest chapter in the draft Annex. At 123 clauses, Chapter 8 represents about 46% of the total clauses in the Annex.

It features 15 sub-headings, 4 of which (Form-Fill-Seal, Lyophilisation, Closed Systems and Single Use Systems) are not explicitly covered in the 2007 Annex. Almost exactly half of the clauses in the chapter (62) are brand new, including all 27 clauses under the new topic sub-headings.

With such a significant rewrite and re-development of requirements, this chapter will be a key focus for manufacturers assessing gaps compared with existing practice. Part 5 focusses on terminal sterilisation of products and related sterilisation processes.

Readers may also wish to view the Initial BlogPart 1, Part 2, Part 3 and Part 4 of this series for context.

Chapter 8, Part A – Sterilised Products & Sterilising Processes (Clauses 1-5 & 30-77)

In this first of two looks at Chapter 8, we focus on sterilised products (clauses 1-5) and sterilising processes (clauses 30-77). All of the topics covered under the 7 related sub-headings are also covered in the 2007 Annex. However the 30 clauses from the previous version have been combined with 4 clauses from other parts of the 2007 version and expanded to 53 in the draft revision.

The sub-headings from the draft revision covered in Part 5 are:

  • Terminally sterilised products (clauses 1-5)
  • Sterilisation (30-46)
  • Sterilisation by heat (47-53)
  • Moist heat sterilisation (54-63)
  • Dry heat sterilisation (64-68)
  • Sterlisation by radiation (69-71)
  • Sterilisation with ethylene oxide (72-77)

Brand New Clauses in Chapter 8

Point of Contention: Clause 8.31 requires the application of QRM principles to certain sterilizer decisions. Some of those decisions are understandable (e.g. selection, design and location of a steriliser), however, the use of QRM as the primary tool to select cycle programs appears unnecessary and possibly inappropriate.

It is more common, and arguably better practice that cycle selection be based on scientific principles and data which demonstrate repeatable, reliable sterilisation. QRM should be a secondary consideration for cycle selection.

Brand New Clauses in Chapter 8 continued

Clauses with Negligible Change in Chapter 8

Clauses with Minor Change in Chapter 8

Clauses with Moderate Change in Chapter 8

Clauses with Significant Change in Chapter 8

Point to Consider: For moist heat sterilization (e.g. autoclaves) 8.60 requires load dryness to be an acceptance criterion for sterilization process acceptance (except for sealed container sterilization). Is this current practice at your facility, or do you rely on load pattern validations?

Initial Blog

Draft Annex 1 – Part 1

Draft Annex 1 – Part 2

Draft Annex 1 – Part 3

Draft Annex 1 – Part 4

Draft Annex 1 – Part 5 (this post)

Draft Annex 1 – Part 6

Draft Annex 1 – Part 7

Draft Annex 1 – Part 8