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Quality control System in Pharmaceutical Industry:

Quality control System in Pharmaceutical Industry Kushwaha Anjali * Asst. Lecturer NVP, Panki Kanpur Email: anjali.kushwaha1@gmail.com * Mob. No.: 09651671789

What is Quality?:

What is Quality? There are so many definitions for Quality. Quality is….. Based on judgments by an individual or organization Degree of excellence Complying with standards Freedom from defects Fitness for purpose Based on acceptable performance Meeting goals Meeting requirements

QUALITY:

QUALITY

What is Quality management:

What is Quality management Quality management is concerned with controlling activities with the aim of ensuring that products and services are fit for their purpose and meets the specifications. There are two main parts to quality management Quality assurance Quality control

What is Quality Assurance?:

What is Quality Assurance? Quality Assurance is the process that demonstrates your product is able to satisfy your users According to ISO definition QA is : "The assembly of all planned and systematic actions necessary to provide adequate confidence that a product, process, or service will satisfy given quality requirements."

Quality Assurance:

Quality Assurance

What is Quality Control?:

What is Quality Control? Quality Control defined by ISO as “The operational techniques and activities that are used to satisfy quality requirements.” An important part of the quality control is the Quality Assessment. The techniques and activities involved in Quality Control can be divided into four levels of operation:

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First-line control: Instrument performance check. Second-line control: Check of calibration or standardization. Third-line control: Batch control (control sample, identity check). Fourth-line control: Overall check (external checks: reference samples, inter-laboratory

Total quality management:

Total quality management TQM is a management that seeks to integrate all organizational functions (marketing, finance, design, engineering, and production, customer service, etc.) to focus on meeting customer needs and organizational objectives. TQM views an organization as a collection of processes. It maintains that organizations must strive to continuously improve these processes by incorporating the knowledge and experiences of workers. The simple objective of TQM is "Do the right things, right the first time, every time".

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TQM is the foundation for activities, which include : Commitment by senior management and all employees. Meeting customer requirements. Reducing development cycle times. Improvement teams. Reducing product and service costs. Systems to facilitate improvement. Employee involvement and empowerment. Recognition and celebration. Challenging quantified goals and benchmarking Focus on processes / improvement plans.

Quality control system In Industry:

Quality control system In Industry Quality control in industry are of fallowing three type- Raw material quality control Vender registration Analytical methodology In process quality control Final products quality control

In process Quality Control :

In process Quality Control IPQC are mostly performing within the production area. They should not carry any risk for the quality of product. In process testing enables easier identification of problems. It some time identifies a defective product batch that can be corrected by rework, whereas once that batch has been completed, this may not be possible. Failure to meet In process control specification indicates either that procedure were not followed or some factor(S) out of control.

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The following control should be done in IPQC Environmental Control/ Prevention of cross contamination Process Control Equipment Control

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In process quality control for various dosage forms I.P.QC for Tablet I.P.QC for Capsule I.P.QC for Liquid I.P.QC for Antibiotics / Bacterial products I.P.QC for Sterile products I.P.QC for Herbal products

Various instrument used in QC department:

Various instrument used in QC department Disintegration apparatus Dissolution apparatus Analytical balance Muffle furnace Friability testing apparatus Bulk density apparatus Tablet hardness tester Infra red moisture content measuring apparatus U.V Spectroscopy Abbe Refractometer T.L.C. kit Karl fisher Titrimeter

Various test perform in Q.C. department for various dosage form :

Various test perform in Q.C. department for various dosage form Test for Tablet Test for Capsule Test for liquid

Control Chart:

Control Chart Control charts are used to routinely monitor quality. There are two basic types of control charts. The first referred to as a uni-varied control chart is a graphical display of one quality characteristic. The second referred to as a multivariate control chart is a graphical display of a statistic that summarizes or represents more than one quality characteristic.

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Types of control chart Control chart for variables X bar chart R chart S chart S**2 chart Control chart for attributes C chart u chart Np c hart p chart

Quality audit :

Quality audit When the desired quality level of the output of the laboratory is reached, it must be maintained and, where necessary, improved. To achieve this, the Quality Manual should contain a plan for regular checking of all quality assurance measures as they have been discussed so far. Such a plan would include a regular reporting to the management of the institute or company. This is usually done by the head of laboratory and/or, if applicable, by the quality assurance officer.

Quality Policy of an Industry :

Quality Policy of an Industry Quality policy and objective should be framed keeping in view of organization:: Vision, mission and policy matter to sustained and developed business. Commitment to develop and implement Quality Management System (QMS) to achieves business objectives. Commitment to continuously improve upon QMS implementation to achieve customer delight and business prosperity. Commitment to comply with statuary and regulatory requirement as well as customer’s requirements. Facilitate the employees to build and adopt “Quality work culture” as a work of life.

Pharmaceutical quality control Today and Tomorrow:

Pharmaceutical quality control Today and Tomorrow QC is devoted to applying new analytical techniques best use especially during R&D – has to be made of scientific progress. Investigation of the quality of medicines should be favored. Some of the analytical advances will change QC work in the future. To reduce the testing of final products in favor of developing and validating production processes with in-process controls that guarantee the quality of the final product. Analytical networking within drug manufacturing companies because all branches of analytics (in research, development and production) acquire information that facilitates the work of the other disciplines

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THANKS

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