The company relies on an integrated quality control system that covers every step of the product life cycle, from selecting suppliers and receiving raw materials, through manufacturing, packaging, and storage, to distribution and post-market follow-up. This system is built on systematic compliance with GMP (Good Manufacturing Practices), ISO 22000 for food safety management (when dealing with food/nutritional products), and ISO 13485 for quality management systems of medical-use products, which requires strict process and documentation control and risk tracking. This commitment is practically implemented through two main departments working in clear integration: Quality Assurance (QA) and Quality Control (QC).
1) General Framework of the Quality Management System (QMS)
First and foremost, the quality system is built on clear official documents that include: quality policy, measurable objectives, authority and responsibility structure, and Standard Operating Procedures (SOPs) covering all operations. Documents are controlled under a "Document Control" system to ensure that only approved versions are used in the factory and laboratories, and any updates undergo full review, approval, and tracking (versions, dates, approvals). Mandatory training programs are implemented for employees on hygiene, safety, contamination prevention, good laboratory practices, and SOPs, with complete documentation of competency and qualification.
2) Role of the Quality Assurance (QA) Department: Governance, Documentation, and Release
QA is the "system owner" responsible for ensuring that everything is done correctly before evaluating results. Its main roles include:
- Risk and Quality Management:
Under ISO 22000 requirements, risk-based thinking and control points (e.g., HACCP/Product Safety Plan according to the product type) are applied. Under ISO 13485, the focus is on managing product- and process-level risks, documenting them, and reviewing upon any changes.
Supplier Qualification and Supply Chain:
No supplier is approved without evaluation (technical files, certificates of conformity, quality records, and audits if needed). All raw materials or packaging materials come with clear specifications and acceptance criteria, with certificates of analysis (COA) verified and linked to batch numbers.
Change Control:
Any change in raw material, supplier, equipment, manufacturing method, or even a document revision goes through a formal change request evaluated for its impact on quality, safety, stability, and compliance.
Deviation and Investigation Management:
Any malfunction, procedure deviation, or unexpected result is documented and investigated, with root cause analysis and corrective and preventive actions (CAPA) implemented to prevent recurrence.
Review of Production Records and Batch Release:
QA reviews production and packaging records step by step to ensure each stage follows the procedure and QC results meet specifications. Then, decisions are made to release, reject, or hold the batch.
Internal Audits and Management Review:
Regular audits are conducted across departments and processes, with results submitted to management in formal reviews to ensure continuous improvement.
3) Role of the Quality Control (QC) Department: Testing, Verification, and Analysis
QC is the "measurement owner," responsible for ensuring in the laboratory that materials and products meet specifications. Its work typically includes:
Raw Material and Packaging Inspection upon Receipt:
Samples are taken according to an approved sampling plan, followed by identity, purity, and specification compliance tests.
In-Process Control Tests:
Critical indicators during production, such as homogeneity, weight, viscosity, moisture, or any process-related parameters, are monitored to detect deviations early before they affect the final product.
Finished Product Testing:
Comprehensive compliance tests covering physical/chemical properties, microbial safety when needed, and product stability within approved limits.
Laboratory Documentation and Analytical Method Control:
QC uses validated analytical methods, with calibration systems, method verification as needed, and ensures result integrity (records, reference samples, traceability).
4) Environmental Control, Hygiene, and Contamination Prevention (GMP Core)
According to GMP principles, strict measures are applied to elements that may affect quality, such as personal hygiene, work areas, batch segregation, cross-contamination prevention, handling of rejected materials, waste management, and cleaning and sterilization programs. Movement paths for materials and personnel are controlled according to facility design to minimize risks, while storage conditions (temperature/humidity) are monitored to ensure stability.
5) Traceability and Post-Market Complaint & Recall Management
Each product is digitally/documentally linked to a batch number, allowing traceability to raw materials, suppliers, production records, and test results. In case of a complaint, clear procedures are followed: recording, assessment, investigation, CAPA, and if needed, organized and swift recall actions are implemented to protect consumers and maintain compliance.
Conclusion
The key idea is that quality is not an "end-of-line check," but an integrated system: QA ensures that processes are correct, controlled, and compliant with standards, while QC confirms through testing that results meet specifications. With adherence to GMP, ISO 22000, and ISO 13485, quality control becomes a daily culture achieving three clear outcomes: higher safety, consistent performance, and continuous trust in every product batch.