Modern Aspects of Pharmaceutical Quality Assurance (Record no. 58235)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 05049nam a22005415i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 978-981-99-9271-3 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20251030111715.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 240311s2024 si | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9789819992713 |
| -- | 978-981-99-9271-3 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-981-99-9271-3 |
| Source of number or code | doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RS400-431 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | PSB |
| Source | bicssc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | SCI013040 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | PNB |
| Source | thema |
| 245 10 - TITLE STATEMENT | |
| Title | Modern Aspects of Pharmaceutical Quality Assurance |
| Medium | [electronic resource] : |
| Remainder of title | Developing & Proposing Application models, SOPs, practical audit systems for Pharma Industry / |
| Statement of responsibility, etc. | edited by Minal Ghante, Manohar Potdar, Vidhya Bhusari. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 1st ed. 2024. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Singapore : |
| Name of producer, publisher, distributor, manufacturer | Springer Nature Singapore : |
| -- | Imprint: Springer, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2024. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | VIII, 523 p. 1 illus. |
| Other physical details | online resource. |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS | |
| File type | text file |
| Encoding format | |
| Source | rda |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Chater 1 Introduction: Quality Assurance from Perspective of Pharmaceutical Industry -- Chapter 2 Six-sigma Model in Pharma Industry (Part-I) -- Chapter 3. Six-sigma Model in Pharma Industry (Part-II) -- Chapter 4 Developing a practical audit system for a pharmaceutical industry based on six system inspection model -- Chapter 5 -- Compliance Tools to Assist the Drug Industry for Regulatory Audits from Developed Countries -- Chapter 6 Developing an Application Model for Planning, Controlling, Improving and Assuring Quality for Pharmaceutical Industry - covering Quality Planning and Quality Control -- Chapter 7 Developing an Application model for Improving Quality for Pharmaceutical Manufacturing based on the Quality principle- covering Quality Improvement and Quality Assurance Audit -- Chapter 8 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Tablets andCapsule Manufacturing Department -- Chapter 9 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Liquid oral and Ointment Department -- Chapter 10 Developing a simplified model Standard Operating Procedure to implement quality metrics for Pharmaceutical Manufacturing System -- Chapter 11 Documentation and data integrity in Pharmaceutical Industry -- Chapter 12 Quality Risk Management. Chapter 13 Deviation, Change control and CAPA. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | The pharmaceutical quality system ensures that the process performance is suitably achieved, the product quality is regularly met, improved opportunities are identified and evaluated, and the knowledge is constantly expanded. Auditing also plays a crucial role within the pharmaceutical industry. It helps to assess and review quality to improve and build a better system for the benefit of companies. This book aims to develop a tool that will substantially decrease the number of Inspectional Observations and Warning letters, thus eliminating Import Alerts and Consent Decree. This book targets the Pharmaceutical Industry and students of Pharmaceutical Quality Assurance so they can get in hand-ready consolidated information on Pharmaceutical Quality guidelines, Quality metrics, and implementation of simplified SOP guidelines, plant layouts to implement Quality metrics for Pharmaceutical Manufacturing systems in tablets, capsules, liquid orals, and semi-solid dosage forms. The chapters cover the various aspects of Pharmaceutical Quality Assurance. The selection of topics is mainly based on the requirements of Pharmaceutical regulatory guidelines of India, the UK, the USA, Australia, and South Africa. Each chapter includes the abstract, detailed explanation, implementation guidelines, flowcharts, layouts, and Standard Operating Procedure of quality metrics for the Pharmaceutical Manufacturing System. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 67843 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 69808 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 67846 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 69809 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 69429 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Ghante, Minal. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 72791 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Potdar, Manohar. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 72792 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Bhusari, Vidhya. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 72793 |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY | |
| Title | Springer Nature eBook |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9789819992706 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9789819992720 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9789819992737 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://doi.org/10.1007/978-981-99-9271-3">https://doi.org/10.1007/978-981-99-9271-3</a> |
| 912 ## - | |
| -- | ZDB-2-CMS |
| 912 ## - | |
| -- | ZDB-2-SXC |
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