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Introduction to Medicines
Inspections Technical Updates:GMP inspections of Active Pharmaceutical Ingrédients and Finished
Pharmaceutical Products (including Reproductive Health Products)
Prequalification Programme: International norms, standards and guidelines used in inspection activities to ensure wide
applicability
Prequalification Programme: International norms, standards and guidelines used in inspection activities to ensure wide
applicability
USPBP
Ph. Eur.Ph. Int.
Other guidelines e.g. ICH, ISO
5
� Manufactures are inspected by WHO-PQT on a routine basis
using an SOP, and based upon a risk based approach;
� As part of pre-approval activity
� Post approval surveillance
� For special cause e.g. serious complaints
� Before inspection, inspector is required to verify objective of
inspection to be carried out;
� Inspector determines what the scope and depth of the
inspection will be based on product dossier assessment
report(s) and findings of previous inspection, if applicable and
other intelligence;
WHO Prequalification Medicines Inspections Process-1
6
� WHO-PQT inspections may be conducted purely as WHO-PQT inspections, and may be joint inspection with other authorities (e.g. API cooperation scheme);
� WHO PQ conducts system based inspection but also covers product specific elements (e.g. dossier integrity);
� It is possible to prequalify a product which was not specifically covered during an inspection (e.g. same site, same QMS, same production facilities, based on more recent inspection, and depending on specific product risk);
� Up-to-date Site Master File (SMF);
� Review of variation list, complaint register;
� Preparation of tentative inspection plan;
WHO Prequalification Medicines Inspections Process-2
7
� Opening meeting covering introduction and brief
presentation of site
� Inspection to cover an on-site verification of dossier
accuracy and data verification
� Assessment of robustness of Quality System and GMP
compliance, what the company is good at and where
there are gaps and weaknesses
� Observations are based on ‘RED’
� Requirement
� Evidence
� Deficiency
• Review of the company CAPA, and
• Final compliance decision and recommended inspection
re-interval.
WHO Prequalification Medicines Inspections Process-3
8
WHO-PQT Medicines Inspections-1:
0
5
10
15
20
25
30
35
40
API FPP
39
32
Number of GMP Inspections in
2014
Number of Inspections
0
5
10
15
20
25
API FPP
21
14
Number of GMP Inspections in 2015
(Jan-Jun)
Number of Inspections
9
WHO-PQT Medicines Inspections:
0
5
10
15
20
25
30
New Routine Requires
Follow-up
Special
5
30
4
0
Break-up of API sites
API sites
0
2
4
6
8
10
12
14
16
18
New Routine Requires
Follow-up
Special
11
18
3
0
Break-up of FPP Sites
FPP Sites
10
WHO-PQT Medicines Inspections (API):
28
11
Inspection Outcome for API
sites inspected in 2014
Immediate
Compliant
After 1st
round of
CAPA
After 2nd or
more round
26
8
5
Final Compliance Status of
API Sites in 2014
Compliant
Non-
compliant
Requires
Follow-up
11
WHO-PQT Medicines Inspections (FPP):
3
27
1
Inspection Outcome for FPP
sites inspected in 2014
Immediate
Compliant
After 1st
round of
CAPA
After 2nd
or more
round
25
5 1
Final Compliance Status of
FPP Sites in 2014
Compliant
Non-
compliant
Requires
Follow-up
12
WHO-PQT Medicines Inspections:
10
2
8
1
Compliance Status of API
sites during Jan-Jun 2015
Compliant
Non-
compliant
Awaits
CAPA
7
2
5
Compliance Status of FPP
sites during Jan-Jun 2015
Compliant
Non-
compliant
Awaits
CAPA
13
API Sites: Top 10 Areas for Improvements
1. Design, Maintenance and Cleaning of Equipment
2. Product Quality Review (PQR)
3. Process Validation
4. Computerised Systems – data integrity
5. Change Controls
6. Production and Packaging Operations
7. Design, Maintenance & Cleaning of Production Premises
8. Documentation Control
9. Investigation of out of specification (OOS), Deviations