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
Overview of Presentation
⚫ The context
– Procurement
– Supply Chain
⚫ Testing requirements in procurement and supply
⚫ Risk mitigation
2| Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Key Players
• Raw materials suppliers
• Manufacturer
Quality Assurance
• National regulatory authority
• Procurement unit
• Logistics system
• End user
3| Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
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 ?
4| Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Procurement Context
National / International
Procurement Body
National Procurement Body
Procurement in Local /
Procurement in National Market International Market
National Medicines Regulatory Prequalification / qualification
Authority ( NMRA ) of suppliers
5| Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Sourcing / 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
6| Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Rating Table
REGISTRAT. F.P. ANAL. SAMPLE
STABILITY API QA MFG SITE GMP
/ MANUFACT. REFERENCE / PACK. / LAB.
REG in an Highly PHARMACOPOEIA Fully compliant SATISFACTORY
Regulated Country Satisfactory BP/USP/Int.Ph. CEP With MSF GMP AUDIT
6 AVAILABLE
T
MANUF: PIC/S Type 4 + specifications (product oriented)
or eq. country Additional tests TRILING. LABEL Report received H
E
REG in an Highly Compliant
R
Regulated Country Satisfactory PHARMACOPOEIA DMF With MSF
SATISFACTORY A
Type 2+ BP/USP/Int.Ph. AVAILABLE GMP AUDIT
5 MANUF: Non PIC/S
or eq. country
+ GMP specifications
BILING. LABEL
(product oriented) P
E
U
Not REG in an Compliant
Highly Regulated IN HOUSE TF
SATISFACTORY T
Satisfactory With MSF GMP AUDIT
4 Country
MANUF : PIC/S Type 2 EQUIVALENT
METHODS
AVAILABLE
+ GMP specifications (not product I
or eq. country ENGLISH ONLY oriented) C
REG: country of
CORRECTIONS
E
origin (non HRC) Temporarly IN
3 PRODUCER MINOR
COMMITMENT Q
MANUF: Non PIC/s Acceptable HOUSE IDENTIFIED + DEVIATIONS
or eq. country
RECEIVED U
I
REG : any other V
IN HOUSE CORRECTIONS
2 country UNSATISFACTORY
< PRODUCER MAJOR A
STABILITY IDENTIFIED DEVIATIONS + NEW AUDIT
MANUF: Non PIC/s
STUDIES BP/USP/Int.Ph. NEEDED L
or eq. country
E
N
NO STABILITY DEFICIENCIES
NOT REGISTERED.
in any country ANALYTICAL PRODUCER CRITICAL TOO NUMEROUS
C
STUDIES
1 AVAILABLE
METHODS
NOT AVAILABLE
NOT
IDENTIFIED
DEFICIENCIES TO HOPE RAPID E
MANUF: Non PIC/S CORRECTIONS
or eq. country
Rating Table
REGISTRAT. F.P. ANAL. SAMPLE
STABILITY API QA MFG SITE GMP
/ MANUFACT. REFERENCE / PACK. / LAB.
REG in an Highly PHARMACOPOEIA Fully compliant SATISFACTORY
Regulated Country Satisfactory BP/USP/Int.Ph. CEP With MSF GMP AUDIT
6 AVAILABLE
T
MANUF: PIC/S Type 4 + specifications (product oriented)
or eq. country Additional tests TRILING. LABEL Report received H
E
REG in an Highly Compliant
R
Regulated Country Satisfactory PHARMACOPOEIA DMF With MSF
SATISFACTORY A
Type 2+ BP/USP/Int.Ph. AVAILABLE GMP AUDIT
5 MANUF: Non PIC/S
or eq. country
+ GMP specifications
BILING. LABEL
(product oriented) P
E
U
Not REG in an Compliant
Highly Regulated IN HOUSE TF
SATISFACTORY T
Satisfactory With MSF GMP AUDIT
4 Country
MANUF : PIC/S Type 2 EQUIVALENT
METHODS
AVAILABLE
+ GMP specifications (not product I
or eq. country ENGLISH ONLY oriented) C
REG: country of
CORRECTIONS
E
origin (non HRC) Temporarly IN
3 “Rating “3” is
Acceptable
the minimum
HOUSE
to allow a decision at the
PRODUCER pharmacists
MINOR
level
DEVIATIONS
COMMITMENT Q
MANUF: Non PIC/s IDENTIFIED +
or eq. country
RECEIVED U
I
REG : any other V
IN HOUSE CORRECTIONS
2 country UNSATISFACTORY
< PRODUCER MAJOR A
STABILITY IDENTIFIED DEVIATIONS + NEW AUDIT
MANUF: Non PIC/s
STUDIES BP/USP/Int.Ph. NEEDED L
or eq. country
E
N
NO STABILITY DEFICIENCIES
NOT REGISTERED.
in any country ANALYTICAL PRODUCER CRITICAL TOO NUMEROUS
C
STUDIES
1 AVAILABLE
METHODS
NOT AVAILABLE
NOT
IDENTIFIED
DEFICIENCIES TO HOPE RAPID E
MANUF: Non PIC/S CORRECTIONS
or eq. country
Sampling and Testing
Reference samples, Batch testing
Pre-qual
⚫ Reference samples ⚫ Compliance to specifications
submitted in Expression documented, batch release
of Interest for pre- and end of shelf life
qualification / bidding
samples ⚫ Packaging, inserts and
labeling evaluated
⚫ Standard procedure for
routine sampling and testing
⚫ Batch testing ⚫ Conformity to specifications
Risk
tested
⚫ Standard procedure for post
distribution monitoring
9| Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Sampling and Testing
Routine 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
10 | Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Sampling and Testing
Out 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
11 | Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Sampling and Testing
Product 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
12 | Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
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 ?
13 | Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
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
14 | Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
Sampling and Testing
AQL Minor defects ( 21 allowed, 17 found )
Other
Only 2 blister strips
instead of 3 in box
Missing package insert
Die included in laminate Poor die cut at blister Protruding growths
Black spots Small chips with tablets Small growths on tablet
AQL Major defects
A ( 7 allowed ) and B ( 10 allowed )
Other
Two tablets included in
one cavity
Disintegrating tablets
Tablet partially formed Poor die cut at blister Broken tablet < 25%
Missing tablets Broken tablets > 25% Break in foil >25%
Sampling and Testing
Product complaints and Quality failure
Any other questions ….. ?
Small group exercise …..
18 | Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
