1. 7th to 8th NOVEMBER, 2017, KAMPALA, UGANDA
Proficiency Testing Scheme for Pharmaceutical Laboratories: East African Regional Experience
E. Kaale, R. Shedafa, P. Tibalinda, V. Manyanga, D. Feldmann, T. Diergardt,
REGIONAL FORUM ON QUALITY ASSURANCE SERVICES FOR THE PHARMACEUTICAL SECTOR
7th to 8th NOVEMBER, 2017, KAMPALA, UGANDA
in cooperation with

2. Reliability/credibility
EAC Pharma Testing
Background
-NMRAs, Industry, Uni.
The QC laboratory provides a service and is like a manufacturing unit – its “products” include test results, advice and investigations
Reliability/credibility

3. Assuring quality of test results
Lab shall have QA Tools/procedures
Use of CRM
Participation in PT
IQC
Replicate tests
Re-testing
Use of Validated methods

4. Proficiency Testing Scheme Def
Evaluation of participant performance against pre -established criteria by means of inter-laboratory comparisons
AIM
The objective is to provide a quality assurance tool to laboratories and to give them an opportunity to compare performance and take remedial action in preparation for ISO/IEC accreditation status.

5. Proficiency Testing Provider
PTB supported Pharm R&D Lab,
to become a regional PT provider for pharmaceutical testing laboratories.
Planning and execution are based in the ISO/IEC Conformity requirement where the statistical evaluation as per ISO/IEC requirement using z-score and excluding outliers with Cochran's and Grubbs' test

6. Proficiency Testing Plan
Determination of the Reference value/Concensus assigned value: Evaluation statistics: Z-score <2 = satisfactory; 2-3 = questionable; >3 = non satisfactory Number of samples: just enough Number of (20) R4(16) R5 (13) R6 laboratories participants: a minimum of 12 laboratories Sample container : Pharmaceutical Amber plastic bottles

7. Proficiency Testing Plan
Matrix: Tablets /Capsules Rounds: 4: 2015 Assay of Paracetamol tablets by UV method 5: 2016 Assay of Quinine tablets by Titration 6: 2017 Assay of Albendazole by HPLC On going with delays 7: 2017 Dissolution of Albendazole Tablets Samples will be dispatched Dec : 2018 Proposed Assay of Metronidazole Tablets Samples will be dispatched May 2018

8. PT Process PT announcement (web, email) Participants Registration
Sample preparation
Sample Dispatch
Labs Test
Submit results
Evaluation preliminary results
Evaluation workshop
Preparation of final report and Certificates

10. Distibution of participation by Country
20 and 15 laboratories have participated in round 4 and 5 respectively
Tanzania (5) Kenya (2), Uganda (5), Rwanda (2) Burundi (2), Ethiopia (2), Eritrea (1) and Congo DRC (1).
Participants were distributed as follows.
NMRAs/NDQCL (30%),
NBS (15%),
Industry (35%),
University (5%),
Others (15%).
Round 6 only 13 registered and 10 have submitted results
Round 7 only 4 labs have paid

11. Example: PT results Sample 1
* s = satisfactory; q = questionable; n = non satisfactory

12. PT results Sample 1 Including all results Mean 354.14 STDEV 23.29 RSD
6.58 n
15.00
Excluding outliers with Cochran's and Grubbs' test
350.32
10.47
2.99
11.00
Excluding results with │Z│> 2
353.13
9.37
2.65
13.00

13. Bar –chart of Z scores for sample 1

14. Possible causes of deviations
Weighing errors of samples 
Variability of response within a series End point readings. 
Use of un-calibrated balances
Solutions preparations 

15. PT Summary perfomance Sample 1 Sample 2 Sample 3 Satisfactory 12 8
Questionable 1 4
No Satsfactory 2 3

16. Comparative perfomance
In general the Round 5 results reported were very encouraging with 80%, 53%, and 80% reporting satisfactory results compared from Round 4 which reported 66 %, 55%, and 50% for sample 1, sample 2 and sample 3 respectively.

17. S1=6 tablets S2=20 tablets S1=20 tablets
Sample size
S1=6 tablets S2=20 tablets S1=20 tablets
20 T
20 T
6 T
What Can we conclude ??

18. The importance of Proficiency testing
Identification of potential problems and implementation of preventive and corrective actions, many times related to performance of staff and/or equipment calibration;
Demonstration of competence to accreditation services;
Provide individual confidence to lab and analyst that results given to its customers.
Determine the individual performance of testing laboratories and help the continuous monitor performance;

19. The Challenges Proficiency test Scheme
Low participation rates
Extra work ??
Costly??
Not seen immediate benefit??
Delays in submission of results
Competing priority analysis
Equipment breakdown

20. Concluding Remarks and Wayforward
A great opportunity for both the provider and participants following the lessons learned which forms the ground for Continuous Quality improvements.
The experience gained is useful for the further preparation towards ISO/IEC accreditation
Appeals to EAC pharma testing labs to actively participate

21. Ackwledgements PTB EAC Secretariat ALL Participants MUHAS
in cooperation with
Ackwledgements
PTB
EAC Secretariat
ALL Participants
MUHAS