As highlighted in the Global Benchmarking Tool ⁽¹⁾, ‘The laboratory testing regulatory function is intended to ensure that the National Regulatory Authority (NRA) is able to assess the quality of medical products by performing quality tests on them in certain situations’. ‘If a country is able to provide all the resources needed, a laboratory under the responsibility of the NRA or a governmental laboratory represents the best choice. Commonly, this governmental laboratory is a national control laboratory (NCL). As an alternative option, the regulatory system may have access to external laboratories, either inside or outside the country, to perform the required tests on behalf on the NRA/NCL. When external laboratories are used, regulatory decisions and actions remain at the discretion of the NRA/NCL and the NRA/NCL retains accountability’.

To support their mission, a robust Quality Management System is essential for  NCL. The QMS ensures that the NCL produces valid and reliable tests result consistently. Especially, it contributes to:

• Ensure compliance with regulatory requirements
• Ensuring validity and reliability of test results
• Facilitate continuous improvement
• Enhance customer satisfaction

This section provides an overview of the main tools available to test and improve NCL’s QMS

Several tools targeting development of human resources from NCLs were identified:

• Visits (e.g. 2-3 days) to observe how another NCL is organized and functions
• Placement, i.e. a staff from one country would temporarily work in another country NCL to gain experience
• Participation in the benchmarking of another country as observer to learn about other systems and benchmarking procedures

These tools allow to understand other NCL’s QMS, contribute to building trust towards increasing communication, information sharing between NCLs and to strengthen collaboration.

In addition, several needs for trainings were identified, including Quality Management System, Good documentation practices, Verification and Validation of test methods, Quality control tools, Equipment qualification, Basic and advance training for developing laboratories.

A memorandum of understanding (MOU) is an agreement between two laboratories or parties which outlines the responsibilities of each party in the agreement. It can limit itself to establishing the ground rules for some partnership activities or have a more legally binding and contractual nature, which depends on its content and the signatories' position. It is also one of the means through which an NCL may outsource some activities to another foreign NCL or other designated laboratories.

NCL capacities often do not allow them to conduct all types of tests or test all types of products, and pursuing exhaustive capacity may not be an optimal use of limited financial, material and human resources.

The MoU should define the roles and responsibilities of each of the NCL or involved parties. Further guidance can be found in the WHO good practices for pharmaceutical quality control laboratories (section 9 Contracts) and in the description of the Global Benchmarking Tool’s sub-indicators RS05.09, RS10.01, and LT10.01.

Beyond outsourcing of testing, MoUs can also be a means to provide a framework and encourage larger collaboration, such as training, visits, placements, and information sharing.

In order to map the existing capacities of NCLs in the region in implementing the tools identified to improve QMS and to support each other, a survey was circulated.

Overall, the survey identified that several countries in the region have documented certification or technical capacity:

Technical capacity	Country
ISO 9001:2015	Indonesia, Thailand
ISO/IEC 17025: 2017 for laboratory testing	Bangladesh, Indonesia, Myanmar, Thailand
ISO/IEC 17025: 2017 for laboratory instrument calibration	Indonesia
ISO 17034:2016 for Reference Standard	Indonesia, Thailand
WHO Prequalification	Bangladesh, Indonesia, Thailand
GBT ML3 or ML4 for LT	Indonesia, Thailand
GBT ML3 or ML4 for LR	Indonesia, Thailand

 

Capacity to conduct proficiency testing	Country
Certified ISO 17043:2010 for Proficiency Testing Provider	Myanmar, Thailand
Ongoing ISO 17043:2010	Indonesia
Planned ISO 17043:2010 (with dates)	Bangladesh, Thailand
No ISO 17043:2010 certification nor plan	Bhutan, Maldives, Nepal, Sri Lanka, Timor-Leste

 

Further, the responding NCLs generally indicated that they had some capacity to accommodate for:

• Visits from other NCLs (e.g. 2-3 days)
• Placements (i.e. a staff from one country would temporarily work in another country NCL to gain experience)
• Trainings
• Inter-laboratory testing
• Memorandum of Understanding

There were also willingness from the NCLs to support each other. However, to achieve this the following challenges would need to be overcome:

• Financial resources
• Lack of programme/ framework and uncertainty on higher management support
• Technical capacity

Another survey was conducted to priotize the needs to be addressed in this strategy. Respondents were requested to grade each of the possible identified activities in terms of:

• Criticality: This factor assesses how quickly a task or issue needs attention. Critical matters require immediate action or a short-term response to prevent negative consequences or take advantage of time-sensitive opportunities. It's crucial to prioritize tasks based on their criticality to ensure timely resolution and prevent them from becoming more problematic.
• Growth: This factor pertains to the potential for a task or opportunity to contribute to long-term development or improvement. This factor considers whether addressing a task or pursuing an opportunity aligns with the overarching goals and objectives. Prioritizing tasks with growth in mind can help make strategic decisions that lead to sustainable progress and positive outcomes in the future.

Highlights:

• There was no significant difference in ranking between criticality and growth
• Activities were prioritized in the following order:
  1. Hands on trainings
  2. Theoretical trainings
  3. MoU / Contracts between NCLs
  4. Inter-laboratory testing
  5. Visit to other NCLs
  6. Placement in other NCLs
  7. Peer Audit
• It was further noted that 4 SEARN Members have currently mechanisms in place to host hands-on-training, subject to payment
• MoU was identified as the most suitable tool to combine the needs of each NQCL and perform the prioritized activities
• Regarding training, it was also noted trainings may be organised by WHO and partners in a hosting NQCL with participation from other SEARN members.

 

Piloting testing and proficiency / interlaboratory testing exercise for EG/DEG

In line with the work conducted under AP14 Integrity of excipient, it was agreed to pilot both regional collaborative testing (confirmatory testing) and proficiency / interlaboratory testing exercise for EG/DEG.

Expressions of interest were received from 3 SEARN Members. It was identified that the implementation of these programmes will require MoU or contracts, including financial aspects/costs mechanism. These documents should also mention:

• number of required samples, timelines, information sharing, test methods, content of CoA
• With regards to testing, minimum number of units to be tested, reference test methods, testing parameters (and price per parameter)

In addition, the implementation will require resolving practical challenges related to customs, payment in local currency, and costs. To resolve this issue, a template was developed which will serve as a basis to develop practical guides to test in the NQCL of another SEARN Member:

Practical guide to sending samples for testing

SEARN Strategy to facilitate reliance

 

The Assembly of SEARN adopted on 27 July 2023 a Strategy to facilitate reliance. This strategy includes a definition of a reference regulatory authority and general principles which can be followed to identify reference regulatory authorities. Further, for the laboratory testing function, possible criterion were identified for selecting a reference regulatory authority.

Information sharing on NQCLs’ capacities in the region

SEARN will work towards establishing a repository of information about the current technical capacity of each NQCL in SEARN, which would be hosted in SEARN platform. This will enable each NQCL to better decide with which NQCL they intend to establish an MoU and contribute to having better worksharing mechanisms.

Regional list of reference Quality Control Laboratories

Combining the general criteria for reliance and the specific information on NQCL’s capacities in the region, WG1 will decide of the inclusion of a quality control laboratory in a Regional list of reference Quality Control Laboratories intended to facilitate reliance.