Table 1
QUAMED rating system and basic requirements for compliance with the WHO-MQAS
| 15 Key activities of the WHO-MQAS | Strong compliance (rate 4) |  Non-compliance (rate 0) |
|---|---|---|
| GR | ||
| 1. QA autonomy | The QA unit has sufficient autonomy to ensure that all key personnel implement good practices. Personnel responsible for implementing QA policies and personnel responsible for purchasing are independent from one another. | The concept of QA autonomy is not known and QA autonomy is not in place. |
| 2. Documentation system | All activities are performed according to written approved procedures and documented in a standardised manner. The main elements of a documentation system are available and regularly updated (ie, the quality manual, standard operating procedures, list of qualified products and suppliers). | The activities and QA policy are not documented in a comprehensive documentation system; thus, the proper execution of operations is not ensured. |
| 3. Human resources | There is a sufficient number of appropriately trained, educated and experienced personnel to perform key activities. Responsibilities and reporting lines are described in organisational charts and job descriptions. | No pharmacist works in the structure and there are no adequately qualified personnel for QA-related activities. |
| 4. Autoevaluation | A policy for internal and external auditing is available. Internal audits are regularly performed, records of external audits are kept and corrective actions are implemented. | There is no evidence of internal or external audits. |
| 5. QA follow-up | The quality of products is continuously monitored. The distributor is informed in time of any changes to the products that may affect their safety, efficacy or quality. Policies for dealing with complaints exist and recalls are handled according to written procedures. | A system for monitoring the quality of products, for managing complaints and for batch recall does not exist or is not documented. |
| PQ | ||
| 6. Product qualification | Product dossiers are evaluated according to standardised procedures which conform to the WHO recommendations. The quality of the products is evaluated according to a written procedure. | No qualification/assessment of products is in place |
| 7. Manufacturing site assessment | The sites where products are manufactured comply with the WHO-GMP, providing assurance that the facility can manufacture the product as specified in the product dossier. | There is no procedure or standards in place for assessing the sites where products are manufactured. |
| 8. Qualification decision | The decision to qualify products for purchase is taken according to a written procedure. Roles and responsibilities are clearly identified. PQ and purchase are clearly separated. | The decision to qualify products for purchase is not described in a written procedure. Roles and responsibilities are not defined. |
| GDP | ||
| 9. GDP | The management of the warehouse follows written procedures. Pharmaceutical products are received and stored in compliance with the WHO Good Storage Practices for pharmaceuticals. Products' quality and integrity are preserved and batch traceability is maintained. | No standards for products’ reception and storage are present/implemented. The management of the warehouse is not organised. Activities and responsibilities are not defined in written procedures. |
| 10. Control at reception | Incoming products are checked for correspondence with the purchase order, integrity and conformity to quality requirements. Products are released for distribution, or quarantined for investigation, according to written procedures. Roles and responsibilities are clearly defined. | There are no written procedures for reception and release of products. Responsibilities are not clearly defined. |
| 11. Distribution | Products’ integrity and quality are maintained throughout the distribution process. Orders’ preparation and transport conditions are described in written procedures, temperatures are monitored and products are traceable from the point of supply to the point of delivery. | Products’ integrity and quality are not assured throughout the distribution process. Order preparation and transport conditions are not described in written procedures. There is no traceability along the product supply chain. |
| QC | ||
| 12. QC | A QC plan is described in a written procedure, and a subset of samples are analysed for compliance with the product specifications by an independent accredited laboratory. | There is no QC and/or no records of QC are available. |
| RE | ||
| 13. Qualified sources monitoring | Dossiers of qualified products are regularly reviewed and suppliers are reinspected, according to a written procedure, to ensure that the products continue to meet adequate norms and standards over time. | There is no system for products’ re-evaluation and suppliers’ reinspection. Quality of products is not continuously monitored. |
GDP, good distribution practices; GMP, Good Manufacturing Standards; GR, general requirements; MQAS, Model Quality Assurance System; PQ, prequalification; QA, quality assurance; QC, quality control; QUAMED, Quality Medicines for all; RE, reassessment.