Following the transition of the WHO Pesticide Evaluation Scheme (WHOPES) to the WHO Prequalification Unit at the beginning of 2017, the latter was tasked with the evaluation, assessment and inspection of vector control products (VCP) for the purposes of WHO prequalification. More specifically, Inspection Services plans, organizes and conducts inspections of VCP manufacturers in support of the prequalification process to ensure VCP quality, safety and efficacy. These inspections assess and verify that VCP manufacturing sites are compliant with ISO 9001:2015 principles and WHO prequalification requirements. Inspection of the quality management aystem (QMS) is restricted to the product(s) submitted for prequalification and mainly aims to:

• evaluate the implementation and effectiveness of the manufacturer's QMS and determine the conformity of the manufacturer's QMS with the requirements of the ISO 9001:2015 principles
• verify the data supporting the claims presented in the submitted product dossier
• verify and assess the manufacturer's policies, procedures, processes (including manufacturing practices) associated with these products.

As for all product streams, WHO plans and coordinates, in accordance with standard operating procedures (SOPs) established by WHO and based on quality management principles, the performance of inspections of the site(s) of manufacture of the active ingredients and the vector control products, and where needed, the contract research organizations (CROs).

The following factors will be considered when planning inspections:

• the results of previous inspection(s) by WHO or a national regulatory authority (NRA), and the history of compliance of the manufacturer or facility with WHO-recommended quality standards, and/or good laboratory practice (GLP), as appropriate
• the outcome of the assessment of data submitted to WHO
• the complexity of the site, processes and product
• number and significance of known quality defects (e.g. complaints, recalls)
• major changes to the manufacturing or research facility (e.g. buildings, equipment, processes, key personnel)
• site experience with manufacturing and testing of a product.

Inspections of manufacturing site(s) are conducted to assess compliance with WHO-accepted quality standards as per ISO 9001 and include data verification. Site master files (SMFs) submitted by the applicant will be reviewed before an inspection is performed. The inspection of CROs may be carried out to assess compliance with GLP and to perform data verification.

Inspections are performed by a team of inspectors, including experts appointed by WHO, preferably from NRA inspectorates, who will act as temporary advisers to WHO. The inspectors must have the relevant qualifications and experience to perform such inspections, be competent in areas such as production and quality control of pesticides, and have appropriate experience in WHO-recommended quality standards and/or GLP. The inspectors must comply with the confidentiality and conflict of interest rules of WHO.

A WHO lead inspector will coordinate and lead the inspection team. The inspection team will perform the inspection, write the inspection report, describing the findings and including recommendations to the applicant, manufacturer(s) and/or CROs where relevant. and share the report with the manufacturer to allow for implementation of any required corrective and preventive measures. A representative of the NRA of the country of manufacture is requested to accompany the team to the manufacturing and testing facilities.

WHO reserves the right to issue a notice of concern, if critical nonconformities of public health concern are identified during an inspection.

In accordance with SOPs established by WHO, and based on quality management principles, an on-site inspection by a WHO inspection team may be waived provided the site in question is found to meet the applicable WHO-recommended standards following a desk review of requested inspection reports, the manufacturer's response(s) to the relevant inspectorate's request for implementation of corrective actions for any deficiencies identified in the inspection reports, and an acceptable product quality review report of the identified product(s).

In addition, an inspection of a manufacturer or CRO may not be required if:

1. An inspection by an NRA has been performed
2. That inspection was conducted within the last three years
3. The information on the inspection (including inspection report and responses to any deficiencies) is available for review by WHO.

The inspection report will be communicated to the manufacturer or CRO as applicable.  With the written agreement of the manufacturer or CRO, a copy of the inspection report may also be provided to the applicant (if other than the manufacturer or CRO). If any additional information is required, or corrective action must be taken by the manufacturer or CRO, WHO will postpone its decision on the acceptability of the site(s) concerned until such information has been evaluated, or the corrective action has been taken and found to be satisfactory considering the specified standards.

WHO reserves the right to terminate this inspection procedure for a specific product if the applicant is not able to provide the required information, or to implement the corrective actions within a specified time, or if the information supplied is inadequate to complete this procedure.

Other types of inspection

In addition to initial VCP inspections, Inspection Services may also conduct:

• follow-up inspections of VCP manufacturing sites: to verify that corrective and preventive actions have been implemented by the manufacturers
• routine surveillance inspections of VCP manufacturing sites: to verify that the QMS and manufacturing practices continue to be compliant with ISO 9001:2015 principles and WHO requirements

Special (for cause) inspections of VCP manufacturing sites: focusing on the specific causes (alert, complaint, etc.) that triggered the inspection.