Quality Control & Quality Assurance: Our Commitment to Excellence
At Asia Talent Chemical, we maintain a comprehensive Quality Management System encompassing both proactive Quality Assurance (QA) and rigorous Quality Control (QC) protocols. This dual approach ensures every product meets the highest standards of safety, efficacy, and regulatory compliance from our partner facilities to your facility.
Quality Assurance: Our Preventative Framework
Our QA system establishes the processes and standards that prevent defects and ensure consistent quality.
1. Supplier Qualification & Management
- Rigorous Audits: We conduct thorough on-site and documentary audits of all manufacturing partners against international GMP standards (e.g., PIC/S, WHO, China GMP).
- Certification Verification: We verify and maintain records of partner certifications, including AEMPS GMP (Spain), ISO 9001, and specific product DMF/CEP/EDMF filings.
- Performance Monitoring: Continuous evaluation of supplier performance based on quality metrics, delivery reliability, and responsiveness.
2. Document & Process Control
- Master Agreements: Quality agreements are established with all key manufacturing partners, defining roles, responsibilities, and quality standards.
- Standard Operating Procedures (SOPs): Comprehensive SOPs govern all our internal processes, from supplier qualification and purchase order review to batch documentation verification and complaint handling.
- Change Control: A formal system to evaluate and communicate any proposed changes in manufacturing processes, specifications, or materials at the partner level.
3. Compliance & Regulatory Vigilance
- Dossier Management: We maintain and provide up-to-date regulatory documentation packages, including:
- Certificate of Analysis (CoA) for each batch
- GMP Certificates
- Stability Data
- DMF/CEP Reference Letters (where applicable)
- Market Surveillance: We monitor regulatory updates in key markets to ensure our partners’ processes and our documentation remain compliant.
Quality Control: Our Verification & Testing Protocol
Our QC function provides the scientific proof that each product meets its predefined specifications.
1. Incoming Batch Documentation Review
Every shipment is preceded by a meticulous review of:
- Batch Manufacturing and Packaging Records
- Complete Analytical Testing Results (Full CoA)
- Sterilization/Processing Records for sterile products
- Stability Data confirmation against the claimed retest/expiry date
2. Sampling & Testing Protocol
- Identity Confirmation: For select high-risk or first batches, we may perform independent identity testing (e.g., FTIR) at third-party laboratories.
- Retained Samples: We ensure our partners retain statutory samples of each batch. We may also hold duplicate retention samples for critical products.
- Third-Party Laboratory Testing: We have agreements with accredited independent laboratories for conducting full or partial pharmacopoeial testing (USP, EP, JP) to verify CoA data, especially for sterile APIs and finished dosage forms.
3. Release & Distribution Control
- Two-Step Release: Products are only released after 1) the manufacturing partner’s QC release and 2) our final review confirms all documentation is complete and compliant.
- Condition Monitoring: We ensure products are shipped under recommended storage conditions (e.g., controlled temperature for sensitive APIs) using qualified logistics partners.
- Full Traceability: We maintain records that provide full traceability from the original manufacturer’s batch number to our sales documentation.
Quality Management System (QMS) Core Elements
- Corrective and Preventive Action (CAPA): A systematic process to investigate deviations, customer complaints, or audit findings, implement corrections, and prevent recurrence.
- Management Review: Regular top-management reviews of the QMS effectiveness, quality objectives, and audit outcomes to drive continuous improvement.
- Training: Ongoing quality and GMP training for our internal staff to ensure deep understanding of regulatory requirements and quality principles.
Our Quality Promise
We pledge to deliver products that are:
- Consistently Manufactured under controlled, GMP-compliant processes.
- Fully Tested and verified against international pharmacopoeial or approved specifications.
- Accurately Documented with transparent and auditable data trails.
- Reliably Supplied through a managed and monitored supply chain.
Partner with confidence. Our integrated QC/QA system is your assurance of product integrity, regulatory compliance, and supply chain transparency.