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

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

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

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 17025 accreditation status.

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 17043 Conformity requirement where the statistical evaluation as per ISO/IEC 13528 requirement using z-score and excluding outliers with Cochran's and Grubbs' test

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

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 2017 8: 2018 Proposed Assay of Metronidazole Tablets Samples will be dispatched May 2018

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

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

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

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

Bar –chart of Z scores for sample 1

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

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

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.

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 ??

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;

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

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 17043 accreditation Appeals to EAC pharma testing labs to actively participate

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