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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:
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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
- …….
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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
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3.3.4, 3.38, 5.22, 5.24
Annex 15 – 2-18. |
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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. |
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|
|
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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
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Guide 4.15 |
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4.6. |
Quality control |
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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:
- Calibration,
8-9 October 2002, Barcelona, Spain
- Design of Equipment,
8-9 October 2002, Barcelona, Spain
- Pharmaceutical Engineering,
9-12 December 2002, Copenhagen, Denmark
- Clean Rooms,
10-12 December 2002, Copenhagen, Denmark
- Spray Drying,
21-22 November 2002, Basle, Switzerland
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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