WG1 Quality

Minutes for the meeting 27 February 2024

Chair: Md. Harun-Or-Rashid (Bangladesh)

Members present in the meeting: Hamida Begum (Bangladesh), Sarwat Jahan Pia (Bangladesh), Sonam
Chophel (Bhutan), Santosh Indraksha (India, on behalf of BK Samantaray), V. Rajappan (India), Arum
Prasetyaningtyas (Indonesia), Dio Ramondrana (Indonesia), Mimin Jiwo Winanti (Indonesia), Sachita
Joshi (Nepal), Saraswati Dangol (Nepal), Gowrie Kathriarachchi (Sri Lanka), Boontarika Boonyapiwat
(Thailand)

Members absent: Amin Ngawang Tashi (Bhutan), BK Samantaray (India), Atiek Supardiati (Indonesia),
Dwi Damayanti (Indonesia), Mirawati Siregar (Indonesia), Aishath Jaleela (Maldives), K.A.P.S. Kuruppu
(Sri Lanka), Paisan Pungjunan (Thailand), Saiwarul Jadoonkittinan (Thailand), Soraya Surasarang
(Thailand), Endang da Silva (Timor-Leste), Antonio Oqui (Timor-Leste)

SEARN Secretariat: Anil Chawla, Naina Sethi, Adrien Inoubli

Other participants: Djamila Reis (WHO HQ), Matthew Scotney (CEPI), Najam us Saqib Mughal (USP),
Saowalak Pomsuwan (Thailand), Tabassum Munira (USP), Topha Shrestha (USP)

Location: Virtual Meeting (the connexion information is shared by email)

Time (IST) Agenda item Lead

13:00 1 Introduction

1.1 Welcome Chair

1.2 Introduction of new members Chair / New members

The working group welcomed one new member:

• Soraya Surasarang (Thailand)

The working group wished farewell to Pavena Kumnerdnon (Thailand) and Witinee Kongsuk
(Thailand) and expressed its gratitude for the contribution to SEARN.

1.3 Adoption of the Agenda Chair / Secretariat

The agenda was adopted unchanged.

1.4 Attendance to the working group Secretariat

The members were presented with the attendance in the working group since the start of the 2023-
2024 workplan.

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 13:15 2 Feedback from the Steering group Chair / Secretariat

The members were informed about the discussions held during the meeting of the Steering group.

13:20 3 Progress in the workplan Chair / Secretariat

13:20 3.1 AP8: Improve the use and access to reference Bangladesh
standards
The WG agreed with the proposed approaches and, specifically, with:
• The proposed regional mechanism for the evaluation of suppliers of reference standards and
the establishment of a regional committee to this end,
• The proposed system to facilitate sharing and testing of samples between the SEARN NQCLs
based on a common simple database.
It was noted that remaining practical challenges would need to be solved for reference/testing NQCLs
(please refer to AP9) and that further discussions are required on the scope.

13:40 3.2 AP9: Strengthen collaboration between National Sri Lanka

Control Laboratories to develop capacity
The WG generally agreed with the proposed approach. In order to secure agreement from the NRAs’
senior management to international collaboration, it was proposed to have a first discussion during
the Assembly, and after in-principle agreement, to finalise an MoU. WG members agreed to further
discuss this proposal with their management.

14:00 3.3 AP14: Ensure the integrity of excipients Indonesia

The WG generally agreed with the proposed approach and, specifically, with:
• the proposal to develop a stronger interface with industry (it was proposed to organise
regular meetings with stakeholders, e.g. in the margin of the Assembly meeting),
• the development by WHO of clinical documentation on EG/DEG contaminations to support
awareness efforts. It was noted that the communication of this material would be left to
national regulatory authorities, and it was requested to further involve NRAs in its
development.
In order to facilitate access to quality control for the industry, several models were discussed, and it
was agreed that NRAs have a central role to play at the national level, in coordination with industry
associations and development partners. Options included the development of a 3rd party laboratory,
sharing of existing industry laboratories, or the development of services from the NQCL, in parallel to
a stricter implementation of regulatory standards.
Regarding sharing of test results for EG/DEG and inspection reports for oral liquid manufacturers,
there was no consensus at this stage, and members agreed to further discuss these options internally,
including with inspectorates. In parallel, members noted that means to facilitate information sharing
continue to be explored in WG4.

14:20 3.4 WHO pharmaceutical starting materials certification WHO HQ

scheme (SMACS)

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Dr Djamila Reis (WHO HQ) presented the ongoing efforts to reactivate the WHO pharmaceutical
starting materials certification scheme (SMACS) and its components. In general, the members
indicated that this scheme could be helpful to support reliance. It was noted that a key enabler would
be that NRAs request for these SMACs in their dossier requirements. Further, there were some
questions related to means to verify the authenticity of the issued documents and on the scope of
regulators.

14:35 3.5 Action points led by other WGs Nepal (AP1), Bhutan (AP3),
 AP1: Capacity building to support Members in India (AP4), Maldives
achieving their objectives of Maturity Level using the (AP5)
Global Benchmarking Tool and/or WLA status
 AP3: Facilitate information Sharing
 AP4: Pilot and develop the internal platform
 AP5: Facilitate reliance
Due to the lack of time, members were informed about the progress of the action points led by other
WGs through email after the meeting.

14:40 4 Good practices during the COVID-19 pandemic Nepal

• Nepal: the timely action of the Department of
Health Services to ensure compliance with Good
Storage and distribution Practices
Nepal presented the timely action of the Department of Health Services to ensure compliance with
Good Storage and distribution Practices during COVID 19:
• This activity was given first priority by the DMSc, the staff did not take holidays, and was
paired to ensure the continuity of activities if one staff member fell sick
• A fast track was set up for lot release and laboratory testing activities within 1-3 working days
• The use of electronic version of the documents to facilitate and accelerate information
sharing
• The use of a dashboard to pilot in real time lot release for COVID-19 vaccines
And general financial support from the government of Thailand which enabled the good conduct of
these activities by the DMSc.

14:50 5 Monitoring and evaluation framework Secretariat

The members were presented with the current status and progress of the indicators adopted for the
action points led by this working group.

14:55 6 Any other business Secretariat

Assembly of the Members

The members were informed that the Assembly of the Members of SEARN will be held in Dhaka,
Bangladesh, from 1 to 4 July 2024.

15:00 7 Conclusion of the meeting Chair

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The Chair concluded the meeting by appreciating the efforts from all members of the working group
and the secretariat.

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