LabTrain pursues a comprehensive approach to strengthen the laboratory capabilities of Quality Control Laboratories (QCLs) in the West African partner countries Ghana, Liberia, Sierra Leone and The Gambia with the aim of improving both the laboratory infrastructure and the quality management systems used. This will enable the pharmaceutical authorities to fulfil their monitoring tasks more effectively in order to ensure that the medicines distributed in their countries meet the required quality standards.

1. Needs analysis: An assessment process in cooperation with the national regulatory authorities should ensure that all important aspects of capacity building for quality control laboratories are considered comprehensively. This includes infrastructure, availability of human resources, required equipment/facilities, regulatory framework and current challenges.
2. Tailor-made capacity building programmes: Building on the results of the needs assessment, tailor-made structural development programmes are developed to meet the specific needs of each country. These programmes are designed to address the individual challenges and priorities of each laboratory and maximise the effectiveness of capacity building efforts.
3. Basic training for QCLs: Complementary to the capacity building programmes, a basic training course is offered for employees of the national pharmaceutical authorities of the LabTrain partner countries whose QCLs are being established or require support in further developing their capacities. It covers all the basic knowledge required to carry out essential pharmaceutical analysis methods as well as the maintenance and qualification of laboratory instruments. In addition, relevant WHO guidelines and the ISO/IEC 17025:2005 standard are taken into account. The training is provided for employees of the pharmaceutical authorities in The Gambia, Liberia and Sierra Leone and is conducted by the Food and Drugs Authority (FDA) Ghana.
4. Cross-country collaboration: Promoting collaboration between countries in West Africa to utilise existing knowledge and resources. This can promote peer learning and facilitate the sharing of best practices, ultimately strengthening the overall capacity of QCLs in the region.

LabTrain aims to improve the staff capacity of African national pharmaceutical quality control laboratories (NPQCLs) by providing structured training programs tailored to their individual needs and development stages. The target groups include the four West African partner countries in the current funding phase as well as the alumni from the previous GHPP DQA project.

1. DQALab training for alumni: Alumni of the GHPP Phase 1 project "GHPP DQA", who have so far only received virtual training, are given the opportunity to participate in a four-week practical training at the Federal Institute for Drugs and Medical Devices (BfArM) and the Institute for Pharmaceutical and Applied Analytics (InphA). The training focuses on practical aspects such as the validation of analytical methods, the teaching of modern spectrometric methods for the identification of substandard medicinal products and the management and handling of chemicals and reference and laboratory materials.
2. Basic training for QCLs: Complementary to the capacity building programmes of structure building, a developed basic training is aimed at staff of the national drug regulatory authorities in The Gambia, Liberia and Sierra Leone who are in the process of establishing and developing QCLs. The training is conducted by the partner authority "Food and Drugs Authority" (FDA) Ghana and covers all basic knowledge for carrying out essential pharmaceutical analysis methods, the maintenance and qualification of laboratory instruments as well as relevant WHO guidelines and the ISO/IEC 17025:2005 standard.
3. Advanced training for established QCLs: These training modules are aimed at partner countries that already have established QCLs and provide them with specific training on advanced topics. The training courses aim to improve the productivity of the laboratories in the long term or to better overcome current challenges. The topics are selected in collaboration with the participating QCLs and alumni of the GHPP Phase 1 project.
4. Development of virtual trainings: Over the course of the project, virtual training courses will be developed that focus on the needs of senior QCL staff and address specific topics such as risk management or the calculation of measurement uncertainty in analytical procedures.

The aim of these training programmes is to improve quality assurance in the QCLs, impart the necessary expertise for setting up and operating laboratories and promote the use of modern technologies to improve the monitoring of medicinal products.

The GHPP LabTrain project supports the World Health Organisation (WHO) in updating and developing monographs for the International Pharmacopoeia (Ph.Int.) and various quality guidelines. The collaboration of the project helps to ensure that quality control laboratories (QCLs) worldwide are able to carry out correct analytical procedures and properly assess the quality of medicinal products on the market according to international standards. As a result, potentially dangerous or substandard products can be recognised and withdrawn from the market before they reach patients.

1. Monographs for anti-infectives

   The Ph.Int. serves as the official source for standard analytical methods and specifications for medicinal products at any point in their shelf life. Monographs exist for a variety of Active Pharmaceutical Ingredients (API) and Finished Pharmaceutical Products (FPP). These freely accessible standards serve as guidelines for pharmaceutical quality control laboratories or can be adopted by WHO member states as national standards. Particular attention will be paid to medicines that are on the WHO list of essential medicines or are of particular importance to WHO health programmes, as other pharmacopoeias may not contain test specifications for these.
   The project will conduct experimental studies to develop and validate appropriate analytical methods for certain anti-infectives. In addition, the findings will be used to define quality requirements for these drugs. The project focuses on pharmaceutical products that play an important role in maintaining the healthcare system in some low-income countries. Monographs for these medicines are either not yet available or outdated.

2. Pharmacopoeial standards for adjuvants in mRNA vaccines

   The novel mRNA vaccines are playing a key role in the global efforts to combat COVID-19. Ensuring the quality and safety of these vaccines is of paramount interest. Robust and standardised analytical methods and internationally harmonised specifications are crucial to ensure that excipients used also meet the required quality standards. This not only reduces the risk of contamination or other quality issues and thus contributes to the safety of vaccines, but also enables better control of manufacturing processes and the pharmaceutical market.
   To support this important task, the LabTrain project is developing monographs for excipients used in mRNA vaccines. The development of these monographs is an important step in ensuring the quality and safety of mRNA vaccines worldwide. This is also important when establishing new production sites in regions such as Africa. By establishing production sites and ensuring high-quality excipients, the local production and supply of vaccines can be achieved and availability and accessibility in previously disadvantaged regions can be improved.

Monographs on the active substances miltefosine, paromomycin and sodium stibogluconate as well as their specific dosage forms are being prepared at the BfArM for the International Pharmacopoeia.

1. Miltefosine
   Draft monograph on the active substance miltefosine:
   https://cdn.who.int/media/docs/default-source/essential-medicines/norms-and-standards/miltefosine-qas21-908.pdf?sfvrsn=e73d6add_2
   Draft monograph on miltefosine capsules:
   https://cdn.who.int/media/docs/default-source/essential-medicines/norms-and-standards/miltefosinecapsules-qas21-887.pdf?sfvrsn=a537cf91_2
2. Sodium stibogluconate and Sodium stibogluconate injection
   The first drafts have been presented at the WHO virtual meeting “Consultation on Quality Control and Pharmacopoeial Specifications of Medicines”, May 2024.
3. Paramomycin
   In progress.

When developing new methods and guidelines, the WHO relies on the support of partner institutions for validation and revision. The BfArM currently has a draft on test methods for ethylene glycol and diethylene glycol (EG/DEG) in finished medicinal products.

1. EG/DEG
   Due to an increase in reported contamination of medicinal products with the toxic substances EG and DEG, which particularly affected children and resulted in deaths, the WHO developed a method for testing for EG/DEG in liquid preparations for oral use.
   https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/current-projects/2023-07-27-deg-eg-inliquidoraldosageforms-qas22-293rev1-forpublicconsultation.pdf?sfvrsn=df629297_1

   LabTrain and the BfArM pharmacopoeia laboratory have assessed this multi-stage approach and provided WHO with suggestions for improvement.

The WHO initiates and coordinates projects on relevant global public health issues. The practical work on central aspects is carried out by partner institutions such as the BfArM.

1. WHO Biowaiver Project
   The WHO Biowaiver Project (currently Cycle VI) aims to create the possibility of replacing bioequivalence studies in drug approval applications with standardised release tests. For this purpose, active substances are categorised in the Biopharmaceutical Classification System (BCS) on the basis of solubility studies.
   https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/current-projects/qas23_936_who-biowaiverproject.pdf?sfvrsn=d62e2485_1