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shubham QA.

Quality Review And Quality Documentation

Chandrashekhar3
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shubham QA.

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  1. CHHATRAPATI SHIVAJI COLLEGE OF PHARMACY, DEORISub - pharmaceutical quality assurance Topic – Quality Review And Quality Documentation Presented By : Shubham B. Kutariya Class : 3rd Year 6thSem GuaidedBy : Badwaik Sir

  2. Quality review / product annual review • Quality review are planned and documented inspections of a review system. • The review item may be product, a group of related products or a part of a product. Principle MANUFACTURING PROCESS MANUFACTURING CONTROLS PRODUCT SPECIFICATION THE 3 REQUIRED FDA OBJECTIVES ARE. • QR studies indicate the product is within the specified limits. • QR all documents to be sure there are no loose ends and also examines testing data to confirm that the product meets specifications.

  3. Q.R. is conduct for verifying consistency of existing process and also conduct for improving the product quality. • Q.R. enhance consistency of manufacturing process and overall quality of the product. SIGNIFICANCCES OF ANNUAL PRODUCT Q.R. ( APQR) APQR help to maintain the existing manufacturing process and quality of product. It is used to determine the quality and any defect of product. It help to maintain the quality of raw material and packaging material which is used for the product.

  4. Quality documentation • Documentation play a key role in the quality management system . • Documentation is an essential part of quality assurance and quality control department • There document should be approved, signed, dated by authorized person. QUALITY DOCUMENTATION HIERORCHY • Quality documentation consist of different types of documents • The QMS documentation can be represented as a hierorchy

  5. Quality policy • All quality objective and goals of organization should be define in quality policy • Q.P of organization should be committed that to give a quality of product and continuous improvement in quality of product. QUALITY MANNUAL • Quality mannual include goals, mission and vision of company. And quality mannual should be approved by upper mannager. • quality mannual mentioned properly. QUALITY MANNUAL SHOULD INCLUDE • TITELS AND TABLE CONTENT • SCOPE OF QMS(QUALITY MANAGEMENT SYSTEM) • RESPONSIBILITY OF PERSONNEL(EMPLOYE)

  6. Work instructions • Works instruction is a part of manufacturing procedure and training of personnel • Work instructions may be cover – • How to use equipment • How to maintain environment and surrounding of our industry • Safety of emplyes • Monitoring of all parameter and risk which can occuring during manufacturing of product RECORDS. • This is final tier in quality documentation system. • All the data information, records, forms, etc.

  7. . • Thank You…………………..

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