Pharmaceutical Industrial Training Report QA QC TORRENT PHARMA

Why Quality is important in pharmaceuticals?

The pharmaceutical environment today is changing quickly due to globalization, increased competition, cost constraints, 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 consistently zero-defect products to the patients.

 The quality, efficacy, and safety attributes of products must be ensured so that consumer health is not compromised.

Impacts of Ignorance on Quality

 Manufacturing process

 Packaging

 Transportation

 Storage condition

 Lack of therapeutic effect:

 Prolonged illness

 Death

 Toxic and adverse reaction

 Waste of limited financial resources

 Loss of credibility QUALITY: A measure of excellence or a state of being free from defects, deficiencies, and significant variations.

 QUALITY ASSURANCE: Obtaining confidence that, the required quality of product or service is satisfactory for their intended use.

 QUALITY CONTROL: Part of GMP is concerned with sampling, testing, and specifications.

Quality Culture

 Support for the Quality Organization

 Actions More Than Words

 Investment in Quality

 Quality Involved in Relevant Business Decisions

 The Quality of the Work You Accept Becomes the Organization’s Standard

 Organizational Structure: Assures that Quality is independent and not subordinate to another organizational unit

Quality Responsibility

Quality is the collective responsibility of every individual in an organization.

It is a well-known belief that quality initiatives are successful only when it is driven from top management to the lower levels of management.

Quality must be Designed into a Product

 Quality is not an add-on: it begins with research and development

 Product quality criteria must be established

 Detailed specifications provide quantitative parameters for measurement

 Written procedures document how quality is attained and maintained

 Continuous monitoring (sampling, testing) to confirm quality is being built-into product

Functions of QA in the Pharmaceutical Industry

To Ensure:

 Raw materials used in the manufacturing are approved and procured from approved vendors.

 All data 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, and investigated to identify the root cause so as to take CAPA to prevent recurrence.

 Preparation of Annual product quality reports, trending of data, and 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.