Professional Documents
Culture Documents
QUALIFICATION
Rutendo Kuwana
Technical Officer, WHO, Geneva
Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and
.assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda
Basic Principles of GMP
Equipment
13
Requalification and
Principle
Equipment must be
– located
– designed
– constructed
– adapted
– maintained
13.1
Calibrated
– scheduled basis
– checks
– records maintained
13.5
Defective equipment
– removed, or 13.9, 13.10
– labelled to prevent use
Artemisinin based combined medicines
February 23-27, 2009, Kampala, Uganda
8|
Equipment
Production equipment
Defective equipment
– removed
– labelled
13.7, 13.10
Possible Issues
Poor design
Lack of safety
Poor quality finishes
Lack of cleaning
Lack of maintenance
No usage log or record
Use of inappropriate weighing equipment
Open-plan location of compressing machines
Remember to look at
punches and dies
3.1 – 3.4
3.1 – 3.4
3.10 – 3.11
3.10 – 3.11
Glossary
Definition
Qualification
Validation
Design qualification
Installation qualification
Operational qualification
Performance qualification
3.11
Design qualification
Installation qualification
Operational qualification
3.11.
4.1 – 4.2
Verifies that equipment has been properly installed and calibrated including
connections to utilities.
5.1 – 5.4
Verifies that the equipment operates consistently within established limits and
tolerances over the defined operating ranges. Studies on critical variable to
include conditions encompassing upper and lower operating limits and
circumstances (i.e. “worst case conditions”)
Show satisfactory performance over a period of time i,e. carried out long
enough to prove that the equipment is under control and turns out product of
specified quality consistently.
1. Purpose
2. Scope
3. Equipment Description
4. Operational Specifications
5. Acceptance Criteria
6. Testing Results
7. Discrepancies/Corrective Actions
8. Conclusions/Final Report
Artemisinin based combined medicines
February 23-27, 2009, Kampala, Uganda
34 |
Validation
The next slide shows a typical format for:
"A qualification protocol / report"
It reflects the minimum information that should be included
7.2
A pharmaceutical firm used two blenders to produce a tablet. Both blenders from same
equipment manufacturer, same model number and same design. Supplier told the drug
manufacturer that the units were "identical." though one was older. Manufacturer did not
include the older blender as part of its process validation.
Company marketed about 100 batches of tablets using the old blender. Retention samples
showed some batches failed content uniformity
investigation showed out of specification batches were from one of the two "identical"
blenders – the old one. The older blender had a slightly smaller capacity and different
operational characteristics (RPMs) when run at the same settings as the newer blender.
Subsequently, the firm recalled its total production of the product it made using the older
blender. The firm decided to qualify the old blender using production size lots .
9.1 – 9.2
Required for:
Start another study using the findings and conclusions from the
failed study
Annex 6