Action point 14 - Strategy to ensure the integrity of excipients


During its meeting on 13 December 2022, the SEARN Steering group requested that a capacity building program is set up on the issue of the integrity of starting materials and the supply chain, in the context of the persisting issues of substandard oral liquid medicines.

Since October 2022, the WHO has shared five Medical Product Alerts reporting contamination of liquid oral medicines with diethylene glycol (DEG) and /or ethylene glycol (EG), which are toxic to humans when consumed and can prove fatal:

This series of serious events has triggered considerable concerns in the region and at the global level and investigations are still ongoing. Further, although similar events contributed to laying down the basis of modern medical products regulation over one hundred years ago, the regular repetition of similar tragedies suggest that regulatory systems can be further strengthened to address this issue.

Considering the above, the SEARN agreed on 13 January 2023 to include this additional action point 14 in its 2022-2023 workplan to ‘Draft a strategy to strengthen members’ capacities in overseeing starting materials and ensuring the quality of finished products, including through the organisation of a regional workshop’.

On 23 January 2023, WHO issued an urgent call to action to countries to prevent, detect and respond to incidents of substandard and falsified medical products.

Scope and definitions

The WHO Good Manufacturing Practices and the Good storage and distribution practices provides the following definitions:

  • Active pharmaceutical ingredient (API) (TRS 986). Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
  • Contamination (TRS 986). The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging or repackaging, storage or transport.
  • Cross-contamination (TRS 986). Contamination of a starting material, intermediate product or finished product with another starting material or product during production.
  • Falsified product (WHO Good storage and distribution practices for medical products). A product that has been deliberately and/or fraudulently misrepresented as to its identity, composition or source. Such deliberate/fraudulent misrepresentation refers to any substitution, adulteration or reproduction of an authorized product, or the manufacture of a product that is not an authorized product. “Identity” shall refer to the name, labelling or packaging or to documents that support the authenticity of an authorized product. “Composition” shall refer to any ingredient or component of the product in accordance with applicable specifications authorized/recognized by the national regulatory authority (NRA). “Source” shall refer to the identification, including name and address, of the marketing authorization holder, manufacturer, importer, exporter, distributor or retailer, as applicable
  • Finished product (TRS 986). A finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling.
  • Good distribution practices (GDP) (WHO Good storage and distribution practices for medical products). That part of quality assurance that ensures that the quality of a medical product is maintained by means of adequate control of the numerous activities that occur during the trade and distribution process, as well as providing a tool to secure the distribution system from falsified, unapproved, illegally imported, stolen, substandard, adulterated and/ or misbranded medical products.
  • Good manufacturing practices (GMP) (WHO Good storage and distribution practices for medical products). That part of quality assurance that ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
  • Material (WHO Good storage and distribution practices for medical products). A general term used to denote starting materials (APIs and excipients), reagents, solvents, process aids, intermediates, packaging materials and labelling materials.
  • Pharmaceutical excipients (TRS 885). Substances, other than the active ingredient, which have been appropriately evaluated for safety and are included in a drug delivery system to: aid in the processing of the drug delivery system during its manufacture; protect, support or enhance stability, bioavailability, or patient acceptability; assist in product identification; or enhance any other attribute of the overall safety and effectiveness of the drug during storage or use.
  • Starting material (TRS 986). Any substance of a defined quality used in the production of a pharmaceutical product, but excluding packaging materials.
  • Substandard products (WHO Good storage and distribution practices for medical products). “Substandard” medical products (also called “out of specification”) are authorized by NRAs but fail to meet either national or international quality standards or specifications – or, in some cases, both.

Considering the issues which triggered this work, and the pre-existing regulatory mechanisms, it was agreed to focus this strategy on ensuring the integrity of excipients, with adequate consideration for substandard and falsified excipients. The strategy should in general look after all excipients, favoring effective implementation of what already exists. The strategy should also include a focus and recommend actions on excipients which may include impurities posing serious risks to public health. To date, only EG and DEG were identified for prioritization.


General objective

To ensure the integrity of excipients through a risk-based approach.

Specific Objectives

  1. To strengthen SEARN Members capacities to ensure compliance with current Good Manufacturing Practices and Good Storage and Distribution Practices
  2. To strengthen SEARN Members capacities to monitor, control, and test the quality of excipients
  3. To draft a regional strategy to further support Members in ensuring the integrity of excipients including through collaboration and information sharing.

Overview of the excipients supply chain

Excipients are an essential component of drug formulations, and any deviation or contamination in their quality or quantity can affect the drug's performance, stability, and safety.

The supply chain and life cycle

The supply chain for excipients is a complex network of activities that involves multiple players, including excipient manufacturers, distributors, brokers, re-packers and end-users such as pharmaceutical manufacturers.

The supply chain typically consists of the following stages:

Raw material sourcing: Excipients can be derived from various sources, including natural, synthetic, or semi-synthetic materials. Raw materials are sourced from suppliers and undergo quality control measures to ensure their suitability for excipient manufacturing.

Excipient manufacturing and quality control: Excipient manufacturers use various processing techniques to produce excipients in different forms, such as powders, liquids, and gels. The manufacturing process involves multiple steps, including mixing, granulation, drying, and milling, followed by quality control testing to ensure the excipients meet the required specifications.

Excipient distribution: Excipients are distributed to brokers, distributors, and end-users such as pharmaceutical manufacturers. Excipient distributors may be local or global, and they often maintain inventories of excipients to provide quick and reliable delivery to customers.

Storage and transportation: Excipients must be stored and transported under controlled conditions to prevent contamination or degradation. Excipient manufacturers and distributors use various techniques to maintain the stability and quality of excipients during storage and transportation, such as temperature control, moisture control, and packaging. Excipient manufacturers, distributors, traders, and end users should follow WHO guidelines for good storage and distribution practice (GSDP)

End-use manufacturing: Pharmaceutical manufacturers use excipients to formulate their products, such as tablets, capsules, creams, injectables and other dosage forms. The excipients must meet specific quality and safety standards to ensure the safety and efficacy of the final product.

Overall, the supply chain for excipients involves a complex multi-layer global network of activities that require coordination and collaboration between various players to ensure the quality, safety, and reliability of excipients. The increasing complexity of the global supply chain brings with it an increased risk in excipient security. This requires implementation of prevention, detection, and response strategies and actions, relying on coordination and collaboration between various players.

Current Good Practices for Excipients

General principles and references

WHO Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients was initially published in 1999 under TRS 885, Annex-5. This guideline is currently being reviewed by the Norms and Standards for Pharmaceutical Team, HQ, Geneva. In view of the ongoing quality issues with some of the pharmaceutical products containing contaminated excipients, the revised guideline will provide clear expectations from the excipient manufacturers using risk-based approach.

Manufacturers must ensure the raw materials procured from appropriate supply chains meet the technical, regulatory, requirements to maintain the safety, efficacy and quality of the finished products. One of the approaches could be the inclusion of critical factor that determines the safety of the raw materials through vendor validation/ formalized quality risk assessment. Further guidance is provided in the

In addition to the supplementary guideline for GMP for pharmaceutical excipients, the excipient manufacturers should refer to the following guidelines:

All parties involved in the distribution of pharmaceutical products have a responsibility to ensure that the quality of pharmaceutical products and the integrity of the distribution chain is maintained throughout the distribution process from the site of the manufacturer to the entity responsible for dispensing or providing the product to the patient or his or her agent.

All entities involved in the distribution process should apply due diligence with adherence to the principles of GDP, for example, in procedures relating to traceability and in recognition of security risks.

Repackaging of pharmaceutical excipients should not be allowed unless it is carried out in a controlled environment meeting the GMP requirement.


The International Pharmaceutical Excipients Council (IPEC) is an organisation of excipient manufacturers, distributors and finished drug product makers intended to promote the best use of excipients in medicines.

IPEC has produced a number of documents which may be relevant to the scope of this work:

Positions Papers:

  1. The 2020 Position Paper on Data Integrity for Pharmaceutical Grade Excipients aims to facilitate the development of appropriate strategies by all parties to manage the integrity of critical data in order to provide confidence in the quality and GMP compliance of the excipient.
  2. The 2019 Position Paper on Supply Chain Security of Pharmaceutical Grade Excipients is intended to provide all parties of the supply chain with support and to highlight available tools.
  3. A 2015 Position Paper supporting Third Party Audits and Certification Programmes rather than self-audits or audits by excipients manufacturers.


  1. The 2022 IPEC Certificate of Analysis (CoA) Guide, intended to serve as a guide for the preparation and appropriate use of a Certificate of Analysis (COA) for pharmaceutical excipients, standardize the content and suggest a format for COAs for excipients, and to define the roles and responsibilities for the excipient manufacturer and distributor.
  2. The 2022 Joint Good Manufacturing Practices Guide For Pharmaceutical Excipients which was revised to incorporate the principles of risk assessment.
  3. The 2021 IPEC Good Distribution Practices (GDP) Audit Guide which was developed as a consolidation of several GDP audit guides to assist the users in evaluating the practices and quality systems of distributors who sell, store or repackage pharmaceutical excipients.
  4. The 2020 Excipient Information Package User Guide and Template is intended to facilitate the excipient supplier’s sharing of information with the user in a standardized way
  5. The 2020 Qualification of Excipients for Use in Pharmaceuticals Guide & Checklist which is meant as a guide for excipient qualification (i.e. to establish the information needed to support the development of products and marketing materials used as excipients, as well as to describe the necessary information for excipient use by pharmaceutical companies).


The complexity of supply chain, both in raw materials as well as pharmaceutical products are involving many parties, such as manufacturers and trading partners (distributors, brokers, traders, and agents).

The APEC Supply Chain Security Toolkit includes concerns about the importance of ensuring the integrity of raw materials in the supply chain, from API, starting materials, excipients, primary packaging, to secondary packaging materials. One of the challenges faced in supply chain management is the many handovers of different material owners; therefore, procurement process of raw materials, becomes a critical point in the supply chain.

Both API and other raw materials have risks in the supply chain, with different levels of risk. This toolkit has also identified risks from raw material procurement, from direct procurement with the lowest risk, to procurement from various types of raw material suppliers, ranging from distributors, brokers, traders, and agents

Risk-based approach for excipients

Formalised risk assessment for excipients

In March 2015 the European Commission published such Guidelines entitled “Guidelines on the formalized risk assessment for ascertaining the appropriate GMP for excipients of medicinal products for human use” according to which the manufacturing authorization holders have now to perform a formalized risk assessment of the excipients used in their drug products and of the excipients manufacturer where they purchase the excipients.

Based on this, a control strategy has to be established in order to manage and mitigate the risks of the use of the excipients Article 47 of Directive 2001 83 /EC provides that “The Commission shall adopt guidelines on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients.

To perform the formalized risk assessment, the medical product manufacturer should refer to ICH Q9 especially tools (such as HACCP) as well as other QRM guidelines such as WHO TRS on QRM, PIC/S Annex 20.

Based on the determination of GMP requirement for an excipient manufacturer, a gap analysis should be performed by the FPP manufacturer and evidence should be maintained If excipient manufacturers are subjected to any GMP and quality system requirement in certain jurisdictions, it should be  considered.

Based on the formalized risk assessment, the medical product manufacturer establishes the risk profile of the excipient, accordingly, establishes GMP requirements for the pharmaceutical excipient manufacturers (e g GMP for APIs or GMP for FPPs or GMP for sterile FPPs).

PIC/S (PI 045 1 1 July 2018 also published Guidelines on the formalized risk assessment for ascertaining the appropriate GMP for excipients of Medical Products for human use.

Stakeholders may also refer to the US FDA Generally Recognized as Safe (GRAS) which lists substances that are generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use.

Further, It is a usual pharma industry practice to sample excipients using a statistical approach (such as under root n+1). A risk-based approach should be adopted by the FPP manufacturers to sample 100% (like for APIs) excipients where there is a potential risk of contamination, cross-contamination, and mix-up. This can be determined based on the manufacturing process of a certain excipient. In addition, based on the composition of the FPP, the FPP manufacturer should take more samples of those excipients whose % is higher than other excipients.

Similarly, it is a common industry practice to perform “paper assessment” of excipient manufacturers instead of performing “on-site” assessment to have more insight about the state of the excipient manufacturers.


Risk factors and risk mitigation measures to consider

Risk factors to consider include:

  • Risk of the excipient/impurity, including route of synthesis (like for the APIs) from excipient manufacturers and assess potential risk of contamination, degradation or impurities during the manufacturing, storage and transportation of excipients.
  • Excipients most at risk of falsification (also considering difficulties of detection)
  • Manufacturing site producing various excipients with little or no cleaning validation
  • Supply Chain – which parts are the most vulnerable
  • Data integrity – valididy / traceability of the data
  • Legality/history of compliance from the manufacturers
  • The pharmaceutical dosage form and the function of the excipients
  • shortage of excipients

Risk mitigations to consider include:

  • vendor qualification and close attention to the procurement, handling (storage & usage), and distribution stages
  • Effective testing of excipients for contaminants
  • Periodic evaluation of high risk excipients suppliers trend analysis

Specific considerations for prioritized issues

It would likely be impossible to implement the full GMP requirements on excipient manufacturers. Based on the tragic incidents that took place in the past as well as in the recent past, a list of excipients may be considered for additional scrutiny. For examples, pharmaceutical excipients used in pediatric formulations (regardless of their dosage forms) should be prioritized for full testing.

During the Regional Workshop on Ensuring Quality of Medicines from Contaminated Substances Jakarta, Indonesia, 2–4 May 2023, NRAs were invited to implement a risk Based approach to address the current situation, e.g. through focusing on manufacturers of oral liquid form. This may be facilitated by various existing tools, including the toolkit for EG/DEG contaminations developed by the USP. Especially, inspection programmes should control the effective implementation of testing for batches and high-risk excipients.

NRAs were also recommended to consider implementing a formalised risk assessment for high-risk excipients, which may require both capacity building for NRAs and for manufacturers.

Member States are encouraged to facilitate the sharing of inspection reports for oral liquid manufacturers with each other, which may be achieved through publishing summary of inspection reports for manufacturers of oral liquid medicines and urgently establishing memorandums of understanding (MoU) between NRAs. NRAs should also ensure that their websites include key information such as GMP status and validity.

Such actions are required to enable reliance for medicines produced in foreign countries. When sufficient and satisfactory information on Good Manufacturing Practices is not available, relying on countries should apply a risk-based approach considering the current risk and the benefits of individual products.

US FDA Guidance on the testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

In May 2023, the US FDA published a guidance on Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.

This document notes that the historical cases of EG/DEG contaminations shared the following similarities:

  • ‘The manufacturers of the liquid drug products that contained contaminated glycerin did not perform full identity testing on the glycerin raw material, including tests to quantify the amount of DEG present and to verify the purity of the glycerin received.
  • The manufacturers of the liquid drug products containing contaminated glycerin relied on the certificate of analysis (COA) provided by the supplier of the glycerin.
  • The origin of the glycerin was not readily apparent from the COA. The COA obtained by the manufacturers of the liquid drug products was often a copy of a COA on the letterhead of the distributor from whom they had purchased the glycerin and not the COA provided by the original manufacturer of the glycerin. The chain of custody or distribution history of the glycerin was also not readily known, often because the glycerin might have been sold multiple times between its manufacture and its use in manufacturing the finished drug product’.

The guidance highlights certain key provisions considered critical, and list specific recommendations for EG/DEG contaminations.

Market control and surveillance of excipients

General considerations

It is critical for countries, regulators, and industry to implement pragmatic and evidence based policies and strategies for market control and surveillance of pharmaceutical excipients without affecting access and costs of pharmaceutical products.

The TRS 929 - Annex 4: WHO guidelines for sampling of pharmaceutical products and related materials, 2005 provides general guidance on surveying the national markets for the quality of drug products in accordance with national drug quality surveillance programmes for marketed products, whether registered for sale or compounded in pharmacies.

Critical measures for ensuring the quality, safety, and efficacy of pharmaceutical products through maintenance of robust market control and surveillance of pharmaceutical excipients, can reduce the risk of harm to patients and ensure the availability of safe and effective medicines. These may include;

  • Quality standards: Countries and regulators should establish and enforce quality standards for excipients. This includes setting specifications for excipient quality, purity, and identity, and ensuring that these standards are met through testing and certification.
  • Supplier qualification: Pharmaceutical manufacturers should ensure that their excipient suppliers are qualified and meet the necessary quality standards. This includes conducting supplier audits, evaluating supplier performance, and monitoring supplier compliance with quality standards.
  • Traceability and documentation: Regulators and industry should require the implementation of robust traceability systems to track the movement of excipients throughout the supply chain. This includes maintaining accurate documentation of excipient origins, processing, testing, and distribution.
  • Risk management: Countries, regulators, and industry should implement risk management strategies to identify and mitigate potential risks to excipient quality and safety. This includes conducting risk assessments, implementing risk mitigation measures, and monitoring for emerging risks.
  • Surveillance and reporting: Regulators and industry should establish systems for surveillance and reporting of excipient quality issues. This includes monitoring adverse events associated with excipient use and conducting post-market surveillance to detect any issues with excipient quality or safety.

Further, excipient manufacturers should report excipients recalls to the appropriate authorities of applicable Member States, and FPP should immediately report excipients which may present a serious risk to public health (e.g. contamination with EG/DEG) to the NRAs.

Specific considerations for prioritized issues

During the Regional Workshop on Ensuring Quality of Medicines from Contaminated Substances Jakarta, Indonesia, 2–4 May 2023 (please see below), NRAs were invited to implement a risk-based sampling strategy to address the current situation, e.g. focusing on oral liquid medicines.

Each container of each lot of an incoming excipient at risk for EG/DEG contamination should be tested for identity and DEG/EG contamination before it is used in the manufacture of a finished product.

The importance of preparedness was also highlighted, and especially to ensure there is clarity in what should be done if a contaminated product was found. This exercise should consider all steps, from the reporting of the suspected product to the investigation, documentation of the destruction of the product, communication, recall, etc.) and all involved stakeholders. There may also be value in organizing a simulation exercise to ensure the robustness of the system.

Member States were requested to share any information related to contaminated medicines using the WHO Global Surveillance and Monitoring System and the South-East Asia Regulatory Network (SEARN) where a strategy on sharing information and guidelines are being discussed (Working group 4, Action point 3 of the workplan). The WHO can facilitate as required.

Considering that the supply chain is international, countries were also encouraged to directly liaise with each other (or facilitated by WHO) and arrange informal meetings between them as part of their investigations.

Testing strategies to ensure the integrity of excipients

Risk-based testing

Risk based testing approach should be shouldered by the NCL and/or NRA. To efficiently utilize scare resources, NCL may initiate and continue to testing of raw materials consecutively for several batches (10 or more) until attainment of confidence through trending of its test results. Besides, the NCL may ask manufacturers to provide full data including test results on raw materials of all batches and trend those results. Comparative trending of data of manufacturer with that of NCL test results also will provide solid evidence for the contamination of raw materials. Once sufficient data is generated, NCL may go for risk-based testing through random sampling. Laboratories in the private sector may be strengthened through training on tests of contaminants on raw materials.

Capacity building needs

During the Regional Workshop on Ensuring Quality of Medicines from Contaminated Substances Jakarta, Indonesia, 2–4 May 2023 (please see below), some Member States requested support in accessing reference standards and reagents, and participants requested the WHO to develop International Chemical Reference Substances. Some NRAs also requested urgent capacity building to implement TLC and Gas Chromatography.

NCLs in the region should be strengthened through provision of availability of minimum level equipment like, TLC, HPLCs. Provisions of advanced level equipment like, Gas Chromatography, Liquid Chromatography Mass Spectrometry (LCMS) is to be ensured for laboratories to confirm adequacy of capacity to test EG/DEG or any other contaminants/impurities in the raw materials.

  • NCL staff should be properly trained on testing of contaminants in raw materials using TLC, HPLC, GC, LCMS etc.
  • Training of the manufacturers and private laboratory staff also will contribute significantly in testing contaminants in the raw materials.
  • NCLs, Manufacturers and Private laboratories also may be encourage to develop test method for identification and quantification of contaminants the raw materials. WHO may collaborate with them to re-validate and acknowledge such test procedure.

To further develop capacity building in the region, the WHO was requested to facilitate the organisation of Inter-laboratory or proficiency testing for both the screening (TLC) and confirmatory (GC) testing methods.

Specific considerations for prioritized issues

To test excipients for contaminations with ethylene glycol (EG), diethylene glycol (DEG), national and regional pharmacopoeias provide test methods and specifications. The International Pharmacopoeia, in addition, describes in the monograph on Paracetamol oral solution a procedure to determine these contaminates in a finished pharmaceutical product.

To enable national quality control laboratories and other stakeholders to test and evaluate suspicious samples, the World Health Organization is developing a test strategy for DEG and EG in liquid preparation of oral use for inclusion in The International Pharmacopoeia. It is intended to use thin-layer chromatography for the screening of suspicious samples and gas or liquid chromatography for the confirmation of non-compliances.

According to the WHO good practices for pharmaceutical quality control laboratories (WHO good practices for pharmaceutical quality control laboratories, World Health Organization, Technical Report Series, No. 957, 2010) equipment for thin-layer chromatography and high-performance liquid chromatograph is recommended for first-stage pharmaceutical quality control laboratories, while gas chromatographs (with flame ionization) are proposed for medium-sized laboratories.

Member States are also encouraged to liaise with each other to urgently establish multiple memorandums of understanding (MoU) between National Control Laboratories, and WHO may facilitate as required. Such MoU should consider specifically address the number of samples to be tested, the cost of testing per sample, target analysis timeframes and requirements for information sharing.

These tests are not intended for manufacturers which should test each contained of each lot of incoming excipient with risk of EG/DEG contamination for identify and purity according to the relevant compendium or alternative acceptable techniques such as FTIR (Fourier transform infrared).

Regional Workshop on Ensuring Quality of Medicines from Contaminated Substances Jakarta, Indonesia, 2–4 May 2023

Regional Workshop on Ensuring Quality of Medicines from Contaminated Substances Jakarta, Indonesia, 2–4 May 2023

A regional Workshop on Ensuring Quality of Medicines from Contaminated Substances was conducted in Jakarta, Indonesia, on 2–4 May 2023, in collaboration with Therapeutics Goods and Administration (TGA) and the United States Pharmacopeia (USP), to support Member States in protecting public health from contaminated medicines. This workshop allowed to develop tailored solutions to address the issue of the contaminated medicines in the region:

Next steps

General strategy on ensuring the integrity of excipients

Provide members on the SEARN website with general principles and a map of key references to ensure the integrity of excipients.

Further, the strategy recommends to:

  • Further explore:
    • a risk-based approach to formulation of oral liquid medicines
    • traceability of excipients and sharing of information between the stakeholder
  • Encourage SEARN members participation in the Member State Mechanism on substandard and falsified medical products
  • Engage with the stakeholders at national and regional levels
  • Provide templates of MoU to facilitate collaboration between the Members of SEARN, as necessary

Excipients which may include impurities posing serious risks to public health

In line with the recommendations from the  regional workshop, the strategy recommends

For laboratory testing:

  • Further define the scope and means of sharing the results of products tested for ethylene glycol / diethylene glycol between SEARN Members, as appropriate
  • WHO to
    • arrange with partners urgent capacity building in the region to implement TLC and GC-FID (including training of trainers)
    • facilitate the organisation of Inter-laboratory or proficiency testing for both the screening (TLC) and confirmatory (GC) testing methods
    • provide support in accessing reference standards and reagents, including through the development of International Chemical Reference Substances.

For regulatory inspections:

  • NRAs to facilitate the sharing of inspection reports for oral liquid manufacturers, and encourage the publication of public summary of inspection reports
  • Build capacity of inspectors through:
    • Observed/coached inspections
    • Organising a regional workshop on Good Storage and Distribution Practice (GSDP)
    • Providing training on the formalized risk assessment for high-risk excipients

For Market control and surveillance:

  • NRAs were invited to implement a risk-based sampling strategy to address the current situation, e.g. focusing on oral liquid medicines
  • Considering that the supply chain is international, countries are encouraged to directly liaise with each other (or facilitated by WHO) and arrange informal meetings between them as part of their investigations

Engage with the stakeholders, including:

  • industry (especially small and medium companies) and
  • learned societies/professional association to ensure awareness on the current situation and early detection of incidents, which may be done are global, regional and/or national level.

2023-2024 Workplan

  • Implement the strategy agreed during the 2022-2023 workplan.