Quality Control (QC)
While the Company’s primary activity is distribution, effective QC oversight is crucial.
•Batch Verification: The QC function is responsible for ensuring the accuracy of batch numbers, expiry dates, and product identity during all handling stages.
•Sampling & Testing (if applicable): If the site performs any required QC activities (e.g., re-testing of bulk product, quality checks on labeling), these are carried out according to documented, validated procedures in a suitable facility (either in-house or via a qualified contract lab).
•Stability Monitoring: Products requiring in-market stability data are monitored in collaboration with the manufacturer.
Quality Risk Management (QRM)
QRM is an integral part of our QMS. It is a systematic process for the assessment, control, communication, and review of quality risks across all operations.
•Process: QRM tools are varied and used proactively to identify potential risks (e.g., storage deviations, documentation errors, unauthorized distribution).
•Control: Identified risks are mitigated through appropriate control measures, documented in the QMS (e.g., SOPs, equipment calibration, personnel training).
•Monitoring: The effectiveness of risk control measures is regularly reviewed and updated.
Quality Management System of the Manufacturer
Our QMS is fully documented, continuously monitored, and actively managed by the Quality Assurance (QA) department. It encompasses the organizational structure, procedures, processes, and resources necessary for effective quality management, supported by top management commitment. The QMS includes:
•Standard Operating Procedures (SOPs) for all key processes.
•Change Control Management.
•Quality Risk Management (QRM).
•Personnel training programs.
•Internal and external audits (Self-Inspection).
Product Quality Auditing (PQA)
We conduct periodic, systematic Product Quality Auditing (PQA) to verify the consistency of the process, the appropriateness of current specifications, and to identify any trends that may suggest the need for process improvements or revalidation. The PQR covers:
•Batch documentation and deviation trends.
•Complaints, recalls, and returns.
•Stability monitoring results (if applicable).
•The status of previous corrective and preventive actions (CAPA).
Release Procedure of Finished Products
The release of medicinal products for distribution is a critical, controlled process executed by the Qualified Person (QP) or authorized personnel.
•For Imported Products: The QP verifies that the product has been manufactured and tested in accordance with GMP and the marketing authorization (MA) requirements.
•For Domestically Sourced Products: Receipt and release checks ensure that the product is received from an authorized source and meets all specified quality and regulatory requirements (e.g., correct documentation, undamaged packaging).
•Documentation: A formal, documented release record is maintained for every batch, confirming that all required checks are completed before the product is physically moved from Quarantine to Sellable Stock.
Management of Suppliers and Contractors
We maintain a strict qualification process for all suppliers (e.g., manufacturers, wholesalers) and contractors (e.g., transporters, testing labs, maintenance services).
•Supplier Qualification: Suppliers of medicinal products are assessed based on their regulatory compliance (licenses, GDP/GMP status) and quality history. Formal Quality Agreements are established where required.
•Contractor Qualification: Contractors providing services that may impact product quality or compliance are formally evaluated, selected, and monitored. Services are defined in a written contract or Quality Agreement.
•Periodic Review: Both suppliers and contractors are subject to regular performance and quality reviews, including audits where appropriate, to ensure sustained compliance.
Self-Inspection
The Company conducts Self-Inspections (internal audits) according to an approved, defined schedule.
• Purpose: To monitor the implementation and compliance of GDP principles and the QMS.
• Process
•: Inspections are conducted by trained, independent personnel. Findings are formally documented, categorized, and addressed through the CAPA (Corrective and Preventive Action) system.
•Review: The outcomes of self-inspections are reviewed by the Responsible Person and management for continuous improvement.
