QUALITY MANAGEMENT SYTEM

4. Quality Management System

Comprehensive, GMP-aligned frameworks to ensure product safety, regulatory compliance, and operational excellence in pharmaceutical and healthcare manufacturing 

• Quality Control

• 4.1 Equipment supply (Labtron & other multinational)

• 4.2 Calibration ( international accreditation) & Equipment repair

• 4.3 Validation & Thermal mapping

• 4.4 Training

• 4.5 Q.C. Chemicals & Glass ware

• Quality Assurance (QA)

• 7.1 GMP Compliance

  • 7.1.1 Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity in performance.

  • 7.1.2 Documentation Practices: Proper .recording and maintaining of all manufacturing processes and tests.

  • 7.1.3 Training Programs: Ensuring staff are trained in GMP and other quality standards.

• 7.2 Quality Audits

  • 7.2.1 Internal Audits: Regular internal checks to ensure compliance with GMP.

  • 7.2.2 External Audits: Audits conducted by regulatory bodies or third parties.

• 7.3 Validation & Qualification

  • 7.3.1 Process Validation: Confirming that manufacturing processes consistently produce products that meet quality criteria.

  • 7.3.2 Cleaning Validation: Ensuring that cleaning processes effectively remove residues to prevent cross-contamination.

  • 7.3.3 Equipment Qualification: Verification of new equipment to meet predefined criteria.

• 7.4 Process Validation

  • 7.4.1 Process Design

    • 7,4.1.1 Development: Designing manufacturing processes that ensure product quality and consistency.

    • 7.4.1.2 Risk Assessment: Identifying and mitigating risks in manufacturing processes.

  • 7.4.2 Process Qualification

    • 7.4.2.1 Installation Qualification (IQ): Ensuring equipment is installed correctly and to specifications.

    • 7.4.2.2 Operational Qualification (OQ): Testing equipment and systems to ensure they operate as intended.

    • 7.4.2.3 Performance Qualification (PQ): Confirming that the process produces the desired product under real-world conditions.

  • 7.4.3 Continued Process Verification

    • 7.4.3.1 Monitoring: Ongoing monitoring of processes to ensure consistent product quality.

    • 7.4.3.2 Data Analysis: Reviewing and analyzing data to detect any deviations or trends.