This course is to emphasize the importance of QUALITY in pharmaceuticals:

• The pharmaceutical environment today is changing quickly due to globalization, increased competition, cost constraint, demands for efficiency, development of international regulation, supply chain complexity, and product/process complexity.  In this fast-changing environment, the people and companies that learn to adapt will prosper
• To manufacture & deliver consistency zero-defect products to the patients
• The quality, efficacy and safety attributes of products must be ensured so that the consumer health is not compromised

To understand Quality Assurance role in the Pharmaceutical Industry: which is to ensure:

• Raw materials used in the manufacturing are approved and procured from an approved vendor
• All data’s are recorded as per cGMP and is reviewed for accuracy and traceability
• Procedures are in place for performing the activities, operating and calibrating the equipment
• Quality is built up in the plant, process, and product. That a Robust Quality system is in place
• Training like induction, on the job, Scheduled and after any changes are conducted to respective individuals on time
• To prepare and approve Quality Policy, Quality Objectives, Quality Manual and Validation Master Plan
• Periodic Monitoring of the Quality Objectives
• Monitors all validation & stability activities are completed as per the schedule
• Ensures that all changes impacting the product and the established systems are documented and reviewed to analyze the impact
• Ensures that all deviations, OOS/OOT & Market complaints are logged, investigated to identify the root cause so as to take CAPA to prevent recurrence
• Preparation of Annual product quality reports, trending of data, determining product and process performance
• To arrange and conduct the self-inspection, identify gaps and take CAPA
• Review of related batch manufacturing records and QC testing data prior to the release of any batch