Quality Assurance

Quality Assurance (QA) is a mark of our philosophy to confirm Quality by Design (QbD) operations at Arwan. Quality Assurance sets forth procedures and ensures related effective compliance to achieve Quality Excellence at Arwan with the highest quality and purity materials procured from US FDA/EMEA approved sources; highly experienced, skilled and trained personnel; a selection of state of the art high-tech machinery; and companywide Current Good Manufacturing Practices (cGMP) (US FDA/EMEA/WHO) compliant procedures.
QA is essential for the maintenance of our integrated management system (IMS) for Good Manufacturing Practices (GMP), and Quality Management System (QMS - ISO 9001:2008) in our operations, including compliance with Health, Safety and Environment requirements (Environment - ISO 14001:2004, Safety - OHSAS 18001:2007).
QA is an integral part of product storage, manufacturing, testing and release with the following key functionalities:

cGMP Compliance
Ensure planning and monitoring of all quality functions that effect product and quality processes through the involvement of GMP in all quality related matters with direct impact on purity, safety and efficacy of drug, and by applying suitable corrective and preventive actions for encountered noncompliance. All the above requirements are supported and followed up by critical review and assessment for all quality related documents according to the Code of Federal Regulations (CFR) 210 & 211 US FDA, European Medicinal Agency (EMEA) and World Health Organization (WHO) Regulations.

Self-Inspection / Internal Audit
Compliance with cGMP through self-inspection/internal audit planning, execution, reporting and follow up.

Review of Records
Review of completed batch production and laboratory control process steps records before release for distribution, in addition to investigation of critical deviations with root cause analysis. Approval of all specifications, master production formulations, instructions and contract manufacturers (if any).

Annual Product Review (APR), Quality Risk Management (QRM) / Management Review
Perform Product Quality Review (PQR)/Annual Product Review (APR), Quality Risk Management (QRM) and Management Reviews.

Planning & Execution of Validation & Calibration
Planning and execution of all types of validation(s) in accordance with the Validation Master Plan, Validation Annual Plan and Validation Policy, and approval of the following validation protocols and reports:
 

  • System Qualification (HVAC, Water, Air, Steam, Nitrogen)
  • Equipment Qualification (Manufacturing)
  • Testing Equipment (Laboratory)
  • Aseptic Process Validation
  • Gowning Qualification
  • Process Validation
  • Cleaning Validation
  • Computer System Validation
  • Calibration of all equipment at facility with Master Calibration Program