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Quality Control Testing
in
Procurement
Helene Möller, M.Pharm, PhD
Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or participating in respective sampling and testing projects, Nairobi, Kenya, 23-25 September 2009
Sampling and testing for Quality Control Laboratories, Nairobi, September 20092 |
Overview of PresentationOverview of Presentation
The context – Procurement– Supply Chain
Testing requirements in procurement and supply
Risk mitigation
Sampling and testing for Quality Control Laboratories, Nairobi, September 20093 |
Key PlayersKey Players
• Raw materials suppliers
• Manufacturer
• National regulatory authority
• Procurement unit
• Logistics system
• End user
Qu
alit
y A
ssu
ran
ce
Sampling and testing for Quality Control Laboratories, Nairobi, September 20094 |
Do you sample and test your products ?Do you sample and test your products ?
How many samples do I need to test ?
When to test ?
What to test for ?
How to interpret the results ?
Sampling and testing for Quality Control Laboratories, Nairobi, September 20095 |
Procurement ContextProcurement Context
National Procurement Body
Procurement in National Market
National Medicines Regulatory Authority ( NMRA )
National / International Procurement Body
Procurement in Local / International Market
Prequalification / qualification of suppliers
Sampling and testing for Quality Control Laboratories, Nairobi, September 20096 |
Sourcing / Prequalification of suppliersSourcing / Prequalification of suppliers
Supplier evaluation, GMP compliance,
Dossier requirements and/or Contract clauses – Identifying the right to inspect and test goods – Appropriate product specifications– Validated test methods
– Documentation of QA and certification requirements
– Specifies product shelf-life requirements as appropriate
On-going supplier performance monitoring
5
4
3
1
2
SatisfactoryType 2+
SatisfactoryType 2
TemporarlyAcceptable
UNSATISFACTORYSTABILITY
STUDIES
NO STABILITYSTUDIES
AVAILABLE
SatisfactoryType 4
PHARMACOPOEIABP/USP/Int.Ph.
IN HOUSEEQUIVALENT
METHODS
INHOUSE
IN HOUSE<
BP/USP/Int.Ph.
ANALYTICAL METHODS
NOT AVAILABLE
PHARMACOPOEIABP/USP/Int.Ph.
+Additional tests
DMF AVAILABLE
+ GMP
TF AVAILABLE
+ GMP
PRODUCERIDENTIFIED +
PRODUCERIDENTIFIED
PRODUCERNOT
IDENTIFIED
CEP AVAILABLE
Compliant With MSF
specifications BILING. LABEL
Compliant With MSF
specifications ENGLISH ONLY
MINOR
DEVIATIONS
MAJOR DEVIATIONS
CRITICAL DEFICIENCIES
Fully compliant With MSF
specificationsTRILING. LABEL
SATISFACTORYGMP AUDIT
(product oriented)
SATISFACTORYGMP AUDIT
(not product oriented)
CORRECTIONS COMMITMENT
RECEIVED
CORRECTIONS + NEW AUDIT
NEEDED
DEFICIENCIES TOO NUMEROUS TO HOPE RAPID CORRECTIONS
6
REGISTRAT. / MANUFACT.
F.P. ANAL. REFERENCE API QA
SAMPLE/ PACK. / LAB.STABILITYSTABILITY MFG SITE GMP
REG in an HighlyRegulated Country
MANUF: Non PIC/S or eq. country
Not REG in an Highly Regulated
CountryMANUF : PIC/S or eq. country
REG: country of origin (non HRC)
MANUF: Non PIC/s or eq. country
REG : any other country
MANUF: Non PIC/s or eq. country
NOT REGISTERED. in any country
MANUF: Non PIC/S or eq. country
REG in an Highly Regulated Country
MANUF: PIC/S or eq. country
SATISFACTORYGMP AUDIT
(product oriented)Report received
Rating Table
THERAPEUTIC
EQUIVALENCE
5
4
3
1
2
SatisfactoryType 2+
SatisfactoryType 2
TemporarlyAcceptable
UNSATISFACTORYSTABILITY
STUDIES
NO STABILITYSTUDIES
AVAILABLE
SatisfactoryType 4
PHARMACOPOEIABP/USP/Int.Ph.
IN HOUSEEQUIVALENT
METHODS
INHOUSE
IN HOUSE<
BP/USP/Int.Ph.
ANALYTICAL METHODS
NOT AVAILABLE
PHARMACOPOEIABP/USP/Int.Ph.
+Additional tests
DMF AVAILABLE
+ GMP
TF AVAILABLE
+ GMP
PRODUCERIDENTIFIED +
PRODUCERIDENTIFIED
PRODUCERNOT
IDENTIFIED
CEP AVAILABLE
Compliant With MSF
specifications BILING. LABEL
Compliant With MSF
specifications ENGLISH ONLY
MINOR
DEVIATIONS
MAJOR DEVIATIONS
CRITICAL DEFICIENCIES
Fully compliant With MSF
specificationsTRILING. LABEL
SATISFACTORYGMP AUDIT
(product oriented)
SATISFACTORYGMP AUDIT
(not product oriented)
CORRECTIONS COMMITMENT
RECEIVED
CORRECTIONS + NEW AUDIT
NEEDED
DEFICIENCIES TOO NUMEROUS TO HOPE RAPID CORRECTIONS
6
REGISTRAT. / MANUFACT.
F.P. ANAL. REFERENCE API QA
SAMPLE/ PACK. / LAB.STABILITYSTABILITY MFG SITE GMP
REG in an HighlyRegulated Country
MANUF: Non PIC/S or eq. country
Not REG in an Highly Regulated
CountryMANUF : PIC/S or eq. country
REG: country of origin (non HRC)
MANUF: Non PIC/s or eq. country
REG : any other country
MANUF: Non PIC/s or eq. country
NOT REGISTERED. in any country
MANUF: Non PIC/S or eq. country
REG in an Highly Regulated Country
MANUF: PIC/S or eq. country
SATISFACTORYGMP AUDIT
(product oriented)Report received
Rating Table
THERAPEUTIC
EQUIVALENCE
“Rating “3” is the minimum to allow a decision at the pharmacists level
Sampling and testing for Quality Control Laboratories, Nairobi, September 20099 |
Sampling and TestingReference samples, Batch testing
Sampling and TestingReference samples, Batch testing
Reference samples submitted in Expression of Interest for pre-qualification / bidding samples
Batch testing
Compliance to specifications documented, batch release and end of shelf life
Packaging, inserts and labeling evaluated
Standard procedure for routine sampling and testing
Conformity to specifications tested
Standard procedure for post distribution monitoring
Risk
Pre
-qu
al
Sampling and testing for Quality Control Laboratories, Nairobi, September 200910 |
Sampling and TestingRoutine sampling and testing
Sampling and TestingRoutine sampling and testing
Risk management approach considers known history of supplier– New suppliers, no / limited history , new products – Well known suppliers, reputable– Supplied in markets with stringent MRA control
Prepare a list of priority items for monitoring
Standard Procedure– Routine referral of every 10th, 25th 100th ( for example ) purchase order to
QA regardless of order value– Referral of all purchase orders exceeding a certain order value– QA criteria for actions:
• Pre shipment inspections• Arrival notification – received in good order …..• Tracking device readings, sampling instruction
Sampling and testing for Quality Control Laboratories, Nairobi, September 200911 |
Sampling and TestingOut of specification ?Sampling and TestingOut of specification ?
Prevention: Inspection/screening of certificates of analysis before shipment institutionalized in business processes
Standard operating procedure – Referral to QA team– Validation of process – confirm specifications, test methods– Assess seriousness of deviations– Consider testing by second independent laboratory– Notification of supplier, NMRA– Implement remedial action– Ensure that action was successfully executed
Sampling and testing for Quality Control Laboratories, Nairobi, September 200912 |
Sampling and TestingProduct complaints and Quality failure
Sampling and TestingProduct complaints and Quality failure
Prevention: Standard procedure up to end-user level– Routine screening for quality defects, product failure– Reporting of complaints– Investigations and documentation needed– Immediate actions in case of concern– Decision making – to use or not, to quarantine, to return
Sampling and Testing– Referral to QA team– Follow standard procedure as for out-of specification– Refer to contracting team - Consider penalties against supplier
Sampling and testing for Quality Control Laboratories, Nairobi, September 200913 |
Do you sample and test your products ?Do you sample and test your products ?
How many samples do I need to test ?
When to test ?
What to test for ?
How to interpret the results ?
Sampling and testing for Quality Control Laboratories, Nairobi, September 200914 |
Are all guidelines for inspections, sampling and testing relevant to pharmaceuticals ?
Are all guidelines for inspections, sampling and testing relevant to pharmaceuticals ?
For example: ANSI/ASQC Z1.4, ISO 2859, BS6001 ?
AQL's: Acceptable Quality Levels – example of laboratory conclusion of conforming to visual inspection requirements of 3 batches sampled in one site
– Critical Defects allowed: 0,1% 0 allowed, 0 found– Major defects A allowed: 0,25% 7 allowed, 4 found– Major defects B allowed: 0.40% 10 allowed, 8 found– Minor defects allowed: 2,5% 21 allowed, 17 found
Sampling and TestingAQL Minor defects ( 21 allowed, 17 found )
Sampling and TestingAQL Minor defects ( 21 allowed, 17 found )
Other
Only 2 blister strips instead of 3 in box
Missing package insert
Poor die cut at blister Protruding growths
Black spots
Die included in laminate
Small chips with tablets Small growths on tablet
AQL Major defects A ( 7 allowed ) and B ( 10 allowed )
AQL Major defects A ( 7 allowed ) and B ( 10 allowed )
Tablet partially formed Broken tablet < 25%
Missing tablets Break in foil >25%Broken tablets > 25%
Other
Two tablets included in one cavity
Disintegrating tablets
Poor die cut at blister
Sampling and TestingProduct complaints and Quality failure
Sampling and TestingProduct complaints and Quality failure
Sampling and testing for Quality Control Laboratories, Nairobi, September 200918 |
Any other questions ….. ?
Small group exercise …..
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