Quality Management and Product Quality Assurance
A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. QMS refers to the entirety of the system.The QMS documents only serve to describe the system.
As part of the Quality Management Unit, Product Quality Assurance covers a wide range of activities that influence the quality, safety and efficacy (or performance) of a health product (pharmaceuticals, medical devices). Product QA helps to identify and manage risks that may negatively impact the quality of a product at different steps of the supply chain, thereby continuously improving our processes to support the delivery of quality-assured products in accordance with ISO 9001:2915 standards, Good Distribution Practices (GDP) and Model Quality Assurance System for Procurement Agencies (MQAS) guidelines.
What the Quality Management and Product Quality Assurance unit does:
The Quality Management unit is responsible for designing, implementing, managing, and improving PFSCM’s QMS.
Product QA unit is responsible for providing quality assurance oversight and ensuring quality compliance in all PFSCM projects. Products procured and supplied by PFSCM for different projects/clients must satisfy defined quality requirements, as per applicable QA policies.
PFSCM’s QA policies and procedures are harmonized with that of our client, The Global Fund and recognize and rely on existing regulatory mechanisms such as WHO prequalification, Global Harmonization Task Force (now known as International Medical Device Regulatory Forum) and decisions of other international technical bodies.
PFSCM works with a wide range of suppliers. Product QA ensures that these suppliers meet the minimum requirements of Good Manufacturing Practices (GMP), GDP and MQAS. PFSCM has a well-established vendor prequalification program that assesses and approves suppliers against these requirements. Currently there are 40 approved wholesalers across 16 countries.
Quality Management System – Key activities include:
- Management of QMU
- Management and upkeep of PFSCM’s QMS
- Internal Audits (QMS) and Self-Inspection (improvement tool)
- Risk Management (improvement tool)
- Incident management (improvement tool)
- External ISO 9001:2015 audits
- Staff training (QMS awareness, incident and risk)
Product Quality Assurance – Key activities include:
- QC sampling & testing of products including release
- Inspection and auditing of suppliers
- Prequalification of products
- Complaints and vigilance, including adverse events
- Organize and coordinate product recalls
- Product master data maintenance, validation and review
- Oversee importation of quality assurance data to the management information system
Quality Management and Products QA resources can be found here:
Report a product quality incident here:
To report a product quality incident or adverse drug reaction, please complete the applicable form found at the links below and submit the form to the QA unit on productquality@pfscm.org
Quality Management and Products QA SOPs, WIs, and Policies can be found here:
Contact details:
Central email account: pfscm_sop_manager@pfscm.org
Central email account: productquality@pfscm.org
- These accounts are monitored daily.
- New QMS documents, policies, SOPs, and WIs should be sent to this account, as well as modifications or updates to existing documents.
- Enquiries about QA requirements of products and eligibility of vendors should be sent to this account. Item creation requests