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 "Inspection of Utilities"
came into force as AIDE MEMOIRE on 1 July 2002

 
During the past decades, the technological and technical field within the pharmaceutical industry has seen more and more advances. However, these advances 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 of utilities used for pharmaceutical manufacture.

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

The Aide Memoire describes the different areas that can be evaluated during an inspection of HVAC systems, water for pharmaceutical use, steam and medicinal gases.
The document contains a table listing these areas, notes, crucial questions as well as supporting documents. The list of supporting documents is an excellent help tool because it enables the reader to study the corresponding regulatory requirements for each item in the Aide Memoire immediately.

Here an excerpt from the table:

1.

Area of operation/Items
HVAC for medicinal products

Notes

Crucial questions

Supporting documents

1.1

Key design parameters

  • Need for separate systems
  • Level of filtration (Filter specifications)
  • Recirculation or make-up air
  • Location of filters
  • Position of inlet and air return, dust extractors
  • Temperature
  • Humidity
  • Air changes
  • Pressure differentials
  • Design of ducting
  • …….
  • How do you prevent cross contamination 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 (April 2001)
EN 1822: High efficiency particulate air filters (HEPA and ULPA):
Part 1 – Requirements, testing, marking;
Part 2 – Aerosol production, measuring equipment, particle counting 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 control reports?
  • 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 pharmaceutical products – factory, clean steam generator)?

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

Confront differences between drawings and reality, unplanned maintenance 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

 GMP Engineering for Professionals

ECA has also focussed its attention on this topic. For specialists and executives in the field of engineering who want to acquire an additional qualification we organise the following events:

 Note

These events are recognised within the framework of the ECA Professional Certification Programme. Please click here for details.

Author: Harald Martin, CONCEPT HEIDELBERG

Here you can download the document.

  

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