Strengthening Quality Assurance (QA) & Quality Control (QC) Systems
Medicine quality is critical to patient health: poor quality can lead to treatment failure, adverse effects, prolonged illness, the development of drug resistance, distrust in the healthcare system, waste of limited financial resources, and death. Poor quality medicines fail to meet official standards for strength, quality, purity, packaging, and/or labeling. They are generally classified as 1) substandard (legally registered innovator or generic products that have been improperly produced, handled, or stored) or 2) counterfeit (products whose identity, strength, or source have been deliberately mislabeled).
To help developing countries strengthen QA and QC systems so that they can better monitor drug supply quality and prevent substandard and counterfeit medicines from reaching patients, PQM provides technical assistance to medicine regulatory authorities, national quality control laboratories, and local pharmaceutical manufacturers.
Working with Medicine Regulatory Authorities to Establish Quality Monitoring Programs
To help national medicine regulatory authorities strengthen their core QC functions, PQM aids those agencies in assessing all aspects of QC, from medicine registration to facility inspection, and from laboratory testing to post-marketing surveillance for quality and adverse drug reactions. PQM determines where gaps exist in the system and suggests how to prioritize corrective actions over time. Technical assistance is tailored to meet these needs and may include:
- Assessing QA and QC systems
- Creating a prioritized plan and timeline for corrective actions
- Recommending structure for legislation and regulations controlling medicine quality
- Systematizing medicine registration and import verification processes
- Training inspectors for Good Manufacturing Practices (GMP) audits and dossier review
- Establishing or strengthening a medicine quality monitoring system—QA/QC and Minilab® Testing
- Building a pharmacovigilance program
Building the Capacity of National Quality Control Laboratories (NQCLs)
One of the first steps toward establishing reliable QC and QA systems for medicines is building the capacity of the national quality control laboratory (NQCL). PQM begins by assessing existing capabilities and recommending improvements in equipment, training, and standard operating procedures for appropriately testing medicine quality. PQM technical assistance may include:
- Assessing laboratory facilities and quality management systems
- Training lab staff in Good Laboratory Practices, documentation, equipment maintenance, and basic testing methods
- Training of trainers for provincial and local labs
- Creating or modifying standard operating practices
- Training lab staff in advanced analytical testing
- Preparing labs to meet international standards
- Conducting audits to prepare for World Health Organization (WHO) prequalification or ISO 17025 accreditation
PQM also helps NQCLs sustain their programs, including providing assistance to become prequalified by the WHO or to reach ISO 17025 accreditation. PQM encourages NQCL managers to build relationships with other NQCLs in the region to share information about poor quality medicines circulating in the area and share experiences to improve their capabilities.
Helping Local Manufacturers Meet GMP & WHO Prequalification
PQM assists local pharmaceutical manufacturers with meeting Good Manufacturing Practices (GMP) and WHO prequalification standards. These internationally accepted standards must be met to ensure good quality products and enable a company to be listed for procurement by international organizations such as UNICEF, donor nongovernmental organizations (NGOs), and national procurement agencies. To this end, PQM experts help with:
- Assessing manufacturer for GMP compliance
- Assisting in dossier preparation, variations, and renewals for WHO prequalification
- Evaluating staff, facilities, equipment, skills, procedures, and existing quality systems
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