QUALITY OF PHARMACEUTICAL INGREDIENTS. WHO Prequalification Programme: Priority Essential Medicines WHO GMP and API Inspections. Presented by Mr. Deus K Mubangizi Technical Officer email@example.com. In this presentation:. WHO-PQ: Inspection activities WHO-PQ: Norms and standards
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WHO Prequalification Programme: Priority Essential Medicines
WHO GMP and API Inspections
Mr. Deus K Mubangizi
1. Classification of an observation is based on the assessed risk level and may vary depending on the nature of API manufactured, e.g. in some circumstances an example of an "other" deficiency may be categorized as "major".
2. A deficiency that was reported at a previous inspection and not corrected may be reported in a higher classification.
3. One-off minor lapses or less significant issues are usually not formally reported, but are brought to the attention of the manufacturer during the inspection.
Other guidelines e.g. ICH, ISO
Increasing GMP requirements
RM (solvent, catalyst, reagent, filtration aid, decolorizing agent, chromatography phase, etc.)
Active substance crude
C, H, O, N
Only flow chart
GMPs do not apply
Active substance (pure)
Photo : Internet
Critical operation with prolonged exposure to the environment
Non critical operation with prolonged exposure to the environment
Non critical or critical operation in a closed equipment
OOS batches blended with others to meet specifications
1. Blending small batches to ↑se batch size
2. Blending tailings
APIs for OSDs/ Suspensions
1. Particle size distribution
2. Bulk density
3. Tap density
1. No approved procedures
2. Specs – carry over impurities
3. Not adequately tested
4. Use not documented
1. Approved procedures
2. Suitable specs
3. Adequate testing
5. Use documented
Trends . . .
2002 to 2009
S. Korea (1)
Number of inspections per year
2007 -2009. Inspections (disease areas) and number of observations