(2003; 148 pages)
i. Re-qualification should be done at regular intervals.
ii. Suppliers will be required to communicate changes that may have impact on the safety, efficacy or quality of the product, to WHO.
iii. Re-inspections of manufacturers will be done at regular intervals at least once every 3 years.
iv. Change to key personnel or the manufacturing site could also result in a re-inspection.
v. Re-evaluation of dossiers will be done every 3 years, or sooner should any change regarding the formula, manufacturing method, or manufacturing site be implemented by the manufacturer.
Re-evaluation may also be done in the following situations:
- If any fraud or omissions by the manufacturer in the initial assessment procedure or during the follow-up activities is evident in relation to the requirements, including compliance with the Good Manufacturing Practices (GMP), recommended by the WHO.
- If any batch or batches of supplied product(s) are considered by WHO or one or more of the UN agencies or organizations not to be in compliance with the agreed specification of the product;
- If a complaint considered to be serious in nature has been received by the WHO or one or more of the UN agencies or organizations;
- If suspension of supply is equal to or greater than one year;
- If, in the opinion of the WHO, changes made in the sourcing of the Active Pharmaceutical Ingredients (API), formulation, manufacturing method, facility or other production aspects require that a re-assessment be made.