New PIC/S Document PI 009-1 "Inspection of Utilities" came into force as AIDE MEMOIRE on 1 July 2002

GMP News No. 229

GMP News
28 August 2002
 

New PIC/S Document PI 009-1 "InspectionofUtilities"
came into force as AIDE MEMOIRE on 1 July 2002

 
During the past decades, the technological and technical field within thepharmaceutical industry has seen more and more advances. However, theseadvances have not only been achieved in the area of production equipment,technology and quality control, but also in the area of auxiliary systems,like HVAC and media systems.

The annual PIC/S seminar 2001 therefore dealt with the inspection ofutilities used for pharmaceutical manufacture.

The Aide Memoire that came into force on 1 July 2002 is the result ofthis PIC/S seminar 2001. It was drawn up in order to facilitate theeffective planning and conduct of GMP inspections of utilities.

The Aide Memoire describes the different areas that can be evaluatedduring an inspection of HVAC systems, water for pharmaceutical use, steamand medicinal gases.
The document contains a table listing these areas, notes, crucialquestions as well as supporting documents. The list of supportingdocuments is an excellent help tool because it enables the reader to studythe corresponding regulatory requirements for each item in the AideMemoire immediately.

Here an excerpt from the table:

1.

Area ofoperation/Items
HVAC for medicinal products

Notes

Crucial questions

Supporting documents

1.1

Key design parameters

  • Need for separate systems
  • Level of filtration (Filterspecifications)
  • Recirculation or make-up air
  • Location of filters
  • Position of inlet and airreturn, dust extractors
  • Temperature
  • Humidity
  • Air changes
  • Pressure differentials
  • Design of ducting
  • …….
  • How do you prevent crosscontamination by air?

PIC/S GMP Guide 3.10, 3.14, 5.10,5.11, 5.18, 5.20. Annex 1- 29-31, Annex 2 -9,10,14,15, Annex 15-9,10
ISO 14644-4: Clean rooms and associated controlled environments –
Part 4: Design and construction.
International Organisation for Standardisation ISO, Geneva (April2001)
EN 1822: High efficiency particulate air filters (HEPA and ULPA):
Part 1 – Requirements, testing, marking;
Part 2 – Aerosol production, measuring equipment, particlecounting statistics;
Part 3 – …….

 

2.

Area of operation/Items
Pharmaceutical water system

Notes

Crucial questions

Supporting documents

2.2

Qualification

DQ, IQ, OQ, PQ and computer validation if needed

  • Drawing, with all sampling points
  • Setting operation and cleaning parameters-I. Stage
  • Consistently PRODUCING WATER of desired quality
  • All qualification completed?

  • For existing systems, show me deviation and change controlreports?
  • Does staff understand what, how and why the work is performed?
  • What do signatures mean?

3.3.4, 3.38, 5.22, 5.24

Annex 15 – 2-18.

 

3.

Area of operation/Items
Pharmaceutical steam systems

Notes

Crucial questions

Supporting documents

3.3

Walk round tour

What kind of steam is used for manufacture of pharmaceuticalproducts – factory, clean steam generator)?

What kind of source water is used for production of steam?

Confront differences between drawings and reality, unplannedmaintenance and change control.

Follow the system in logical order. Pay attention to leaks,sampling points (access), who does what, start up and shutdown,cleaning / disinfection / sterilisation), quantities produced.

  • Feed water-type, level, temperature

  • Sample points- location, number, access
  • System for removal of air loop
  

 

4.

Area of operation/Items
Pharmaceutical gases

Notes

Crucial questions

Supporting documents

4.5.

Monitoring of the system

  • Leakage tests

  • Filter integrity tests
  • Pressure control
 

Guide 4.15

4.6.

Quality control

  • Pollution - oil, water, particles, bio burden

 

Guide 3.43, 4.15, 4.22, 6.7


Author: Harald Martin, CONCEPT HEIDELBERG

Here you can downloadthe document.

  

 

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