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Proficiency Testing Program For PH

This document outlines a proficiency testing program for measuring pH. The program is organized by the Bureau of Drug and Narcotic in Thailand and involves distributing samples of diclofenac sodium to participating laboratories for pH measurement. Laboratories will receive samples in May 2017 and report their results by June 21st, with interim and final reports being issued in August and September, respectively. The document provides details on registration, evaluation criteria, testing methods, and reporting of results.

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Proficiency Testing Program For PH

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PROFICIENCY TESTING PROGRAM 2017

Scheme Code D6004R1

pH Measurement

Protocol No. D6004R1

Organized by
Bureau of Drug and Narcotic
Department of Medical Sciences
88/7 Tiwanon Road, A. Muang, Nonthaburi 11000
THAILAND
Tel. +66 2951 0000 ext. 99137
Fax +66 2580 5733
Email: pt_bdn@hotmail.com; pts.bdn@gmail.com
Bureau of Drug and Narcotic
Department of Medical Sciences
Proficiency Testing Program 2017 - Scheme code D6004R1: pH Measurement

1. ORGANIZER

Scheme Provider:
Bureau of Drug and Narcotic (BDN)
Department of Medical Sciences
88/7 Tiwanon Road, A. Muang, Nonthaburi 11000 THAILAND
Tel. +66 2951 0000 ext. 99132, 99137
Fax +66 2580 5733

Scheme Coordinator:
Ms. Siriphorn Laomanacharoen
Pharmacist, Senior professional level
Email: pt_bdn@hotmail.com; pts.bdn@gmail.com
The scheme coordinator is responsible for all activities of the PT scheme.

2. OBJECTIVE

The objective of this Proficiency Testing (PT) scheme is to demonstrate that

participants can accurately perform pH measurement. The scheme is based on the pH
measurement of pharmaceutical raw material, diclofenac sodium, according to the method
from the 39th revision of the United States Pharmacopeia (USP 39) on Diclofenac Sodium
monograph.

3. SUBCONTRACT

BDN has no policy to subcontract in any activity of this proficiency testing scheme.

4. SCHEDULE OF PT SCHEME

Schedule for the PT scheme activities is as follows:

Activity Schedule
Call for participation December 2016
Distribution of samples May 2017
Deadline for submission of results 21 June 2017
Interim report for comments August 2017
Final report September 2017

D6004R1 PT protocol v 0 Page 2 of 7

Bureau of Drug and Narcotic
Department of Medical Sciences
Proficiency Testing Program 2017 - Scheme code D6004R1: pH Measurement

5. REGISTRATION

Registration Fee:
Local participants 500.- Baht
Oversea participants 200.- USD (Including shipping handling)

Payment:
Local participants-
The payment should be made by Teller payment system at any branches of Krung
Thai Bank Public Company Limited.

Oversea participants-
The payment should be made by bank transfer to
Account name: Bureau of Drug and Narcotic
Account number: 142-1-12831-4
Bank name: Krung Thai Bank Public Company Limited
Branch: Ministry of Public Health, Nonthaburi
Swift code: KRTHTHBK

Method and Deadline for Registration:

Participants should register online via the website http://www.bdn.go.th/pt within
31 January 2017. Registration by other means e.g. fax, Email will not be accepted.

Terms and Conditions:

1. BDN reserves the right to occasionally delay the issue of PT program or use an
appropriate substitute test material with prior warning to participants if the
planned PT sample is not available according to the schedule of PT scheme.
2. The registration fees are nonrefundable.

More information can be viewed on the website http://www.bdn.go.th/pt.

6. CRITERIA FOR PARTICIPATION

Participants should have competency to perform the pH measurement of diclofenac

sodium and use this technique in their routine work.

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Bureau of Drug and Narcotic
Department of Medical Sciences
Proficiency Testing Program 2017 - Scheme code D6004R1: pH Measurement

7. NUMBER AND TYPE OF PARTICIPANTS

Number of participants: 20 - 60
Type of participants: Quality control laboratories in pharmaceutical
manufacturers and other testing laboratories

8. PROFICIENCY TESTING SAMPLE

The sample of this scheme is pharmaceutical raw material, diclofenac sodium with the
details as follows.

Formula C14H10Cl2NNaO2
Molar mass (g/mole) 318.13

Structure

9. HANDLING OF PT SAMPLE

Participants will receive (i) a bottle of sample containing about 600 mg of diclofenac
sodium, and (ii) a Testing protocol.

PT samples are packed in tightly closed containers and distributed in ambient

condition. The PT sample should be stored in the refrigerator between 2-8°C and
protected from light and humidity until analysis.

PT samples are sent by express mail for local participants and by courier for oversea
participants. It is the responsibility of the participants to contact BDN if they have not
received the PT sample within the time schedule. In case of international transport for
oversea participants, BDN cannot be responsible for any delays from the custom
clearance. Upon receipt of PT sample, participants are requested to check physical
conditions of PT sample as well as other substances provided, complete a PT sample
acknowledgement form via the website http://www.bdn.go.th/pt.

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Bureau of Drug and Narcotic
Department of Medical Sciences
Proficiency Testing Program 2017 - Scheme code D6004R1: pH Measurement

10. TEST METHOD

Participants should determine pH value of the PT sample and report the results with
two digits after the decimal separator. The measurement method is based on USP 39 in
general chapters:<791> pH.

Details of the method are described in the testing protocol which will be enclosed with
PT sample. PT sample as well as measure procedure should be handled and operated in
the same manner as performing routine work.

11. ASSIGNED VALUE

The assigned value used to calculate z score is based on the consensus value from
participants using the robust mean calculated according to robust analysis:Algorithm A in
Annex C of ISO 13528:2015-Statistical methods for use in proficiency testing by
interlaboratory comparisons.

12. STANDARD DEVIATION FOR PROFICIENCY ASSESSMENT

Standard deviation for proficiency assessment used to calculate z scores is the robust
standard deviation calculated according to robust analysis:Algorithm A in Annex C of ISO
13528:2015-Statistical methods for use in proficiency testing by interlaboratory
comparisons.

13. PERFORMANCE EVALUATION

Participants will be assessed on the differences between their results and the assigned
value. The z score is used for the performance evaluation as

= z score

= measurement result from participant

= assigned value

= standard deviation for proficiency assessment

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Bureau of Drug and Narcotic
Department of Medical Sciences
Proficiency Testing Program 2017 - Scheme code D6004R1: pH Measurement

The interpretation of z score is designated as follows.

z  2.0 : acceptable

2.0  z  3.0 : warning signal
z  3.0 : unacceptable

For warning signal or unacceptable results, it is recommended that participants

investigate root causes and take necessary corrective actions.

14. POTENTIAL MAJOR SOURCES OF ERRORS

1. Variation of temperature
2. Condition of electrode
3. Incorrect calibration of pH meter
4. Instrument settings
5. Solvent used should be carbon dioxide-free purified water

15. REPORT

An interim report is issued to provide each participant with an early indication of

performance. In general, the interim report is issued about two months after the deadline
for submission of results via the website http://www.bdn.go.th/pt. Participants are requested
to check and review for any correction and/or comment. The final report is issued via the
website www.bdn.go.th/pt after the correction and/or comment of interim report has been
completed.
The report includes the following information.
- Introduction: general description of PT scheme
- Name and contact details of proficiency testing provider and scheme coordinator
- Participation: information of participating laboratories
- PT sample: description, sample preparation
- Homogeneity and stability assessment
- Assigned value, including measurement uncertainty and standard deviation of
proficiency assessment
- Results: result tables including statistic summary data, z scores and bar
chart of z scores
- Discussion of results: conclusion of overall performance and comments on
participants’ performance
- Potential major sources of errors

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Bureau of Drug and Narcotic
Department of Medical Sciences
Proficiency Testing Program 2017 - Scheme code D6004R1: pH Measurement

16. CONFIDENTIALITY, COLLUSION AND FALSIFICATION OF RESULTS

The identity of participants is protected by means of laboratory code which is

randomly assigned in each PT round. These codes are confidential and are not disclosed
to other persons unless agreed by the participant for a regulatory or recognition purpose.
Participants can access their personal information in the website http://www.bdn.go.th/pt
by using username and password which can keep their information confidentially. For
security purpose, participants are recommended to change username and password in case
of changing the responsible person who can access the information in the website.
This PT scheme is conducted in the belief that participants will perform the analysis
and report results with scientific professional. Where any collusion between participants
or falsification of results is proven by BDN, the result of that participant for the PT round
concerned will be cancelled for performance evaluation.

17. LOST OR DAMAGED PROFICIENCY TESTING SAMPLE

In case of lost or damaged PT sample, participants should immediately inform

BDN. The damaged PT sample should be returned to BDN. Replacement will be arranged
if the PT samples are proved to be lost or considered not suitable for analysis. The deadline
of submitting result will be extended to appropriate date if necessary.