QUALITY ASSURANCE AND QUALITY MANAGEMENT CONCEPTS.pptx

INTRODUCTION TO QUALITY ASSURANCE AND QUALITY MANAGEMENT CONCEPTS

Quality control (QC) and quality assurance (QA) are two crucial components in the pharmaceutical industry that play a vital role in ensuring the safety, efficacy, and quality of pharmaceutical products. 

These processes are integral to meeting regulatory requirements, maintaining consumer trust, and ultimately contributing to public health.

1. QUALITY ASSURANCE AND QUALITY MANAGEMENT CONCEPTS

2. Pharmaceutical QUALITY Assurance MEETS THE CONSUMER SATISFACTION

3. Quality control (QC) and quality assurance (QA) are two crucial components in the pharmaceutical industry that play a vital role in ensuring the safety, efficacy, and quality of pharmaceutical products.  These processes are integral to meeting regulatory requirements, maintaining consumer trust, and ultimately contributing to public health. QUALITY CONTROL AND QUALITY ASSURANCE IN PHARMACEUTICAL INDUSTRIES SAFETY:- Drug safety refers more to the overall safety profile of the drug and covers an array of aspects relating to making sure the drug is safe to use by patients & consumers.  EFFICACY  The efficacy of a drug is its ability to produce the maximal response possible for a particular biological system.

4. QUALITY:- Quality can be define as a product with “Zero defects”. OR a product meets the consumer satisfaction. Pharmaceutical quality is  the degree to which a drug meets its intended use and is safe and effective for patients .

5. Quality Control (QC): Quality control in the pharmaceutical industry involves a set of activities and techniques used to evaluate the quality of raw materials, intermediate products, and finished pharmaceutical products. It encompasses both physical and chemical testing & Microbiological Testing as well as the monitoring of manufacturing processes to ensure compliance with predefined quality standards. A system of maintaining standards in manufactured products by testing a sample of the output against the specification. QC is instrumental in ensuring that pharmaceutical products meet established specifications and are free from defects or contamination. Through rigorous testing and analysis, QC helps identify and rectify deviations from quality standards , preventing the release of substandard or unsafe products into the market.

6. Types of QC Tests: Chemical Testing:  Involves analyzing the chemical composition of raw materials and finished products to ensure they meet predetermined specifications. Physical Testing:  Includes assessments of product appearance, stability, dissolution, and other physical characteristics. Microbiological Testing:  Focuses on detecting and controlling microbial contamination, critical in pharmaceutical products where sterility is often paramount. ISO 9000 defines quality control as " A part of quality management focused on fulfilling quality requirements". It is that part of GMP concerned with sampling, specification and testing, documentation and release procedures which ensure that the necessary and relevant tests are performed and the product is released for use only after ascertaining its quality.

7. RESPONSIBILITIES OF QC: QC is responsible for day to day control of quality within the company. QC is responsible for analytical testing of incoming raw materials and inspection of packaging components, including labeling, they conduct in-process testing when required, perform environmental monitoring, and inspect operations for compliance. They also conduct the required tests on finished dosage form. QC plays a major role in the selection of qualified vendors from whom raw materials are purchased. The environmental areas for manufacturing of various dosage forms are tested and inspected by QC department. QC assuring the quality of all the batches manufactured, at every stage of manufacturing/processing Drug Products. Release or rejection of every batch of Drug Products for distribution and sale.

8. Stability testing and evaluation of shelf-life of products. Analysis of Returned products (salvage and disposal). Internal Quality System Audits and Quality Review. Take corrective actions or necessary changes to achieve standards To co-ordinate with manufacturing department in controlling their process and products at every stage of manufacturing to meet the established specifications through testing, auditing and reporting. To co-ordinate for development of specifications, the analytical procedure in coordination with Quality Assurance Dept. and R&D.