Erfan Syed Asif's Books

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

By: Syed Imtiaz Haider,Erfan Syed Asif

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Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

By: Syed Imtiaz Haider,Erfan Syed Asif

To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance. The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements.

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Page Count

586

Publisher

CRC Press

Published Date

ISBN 10

1439886903

ISBN 13

9781439886908

Basics of Pharmaceutical Manufacturing and Quality Operations

A Comprehensive Guide

By: Erfan Syed Asif,Shahid Bader Usmani

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Basics of Pharmaceutical Manufacturing and Quality Operations

A Comprehensive Guide

By: Erfan Syed Asif,Shahid Bader Usmani

This book provides guidance on how to meet the requirements of the pharmaceutical industry as a beginner. It includes procedures for production and packaging, batch auditing as well as all quality measures used in the pharmaceutical industry. This book also provides questions and answers with each chapter for institutes and trainers providing basic training to the new graduates and new comers to the industry. Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide is primarily written for anyone in the pharmaceutical industry interested in development and manufacturing of active pharmaceutical ingredient (API) and finished pharmaceutical manufacturers in both sterile and non‐sterile areas. The book is a simple, concise, and easy to use reference tool covering basic quality concepts required by the pharmaceutical educational institutions and professional certification bodies. It describes details of all GXP activities that are directly related to Quality, Safety, and Efficacy of the products manufactured under the umbrella of Quality Operations, common testing methods which are used in any modern industry, Requirements of Validation and Qualification of equipment, facilities and processes, integral segments of Drug product manufacturing, storage, and distribution practices. The material provides stepwise guidance on how to evaluate, audit, qualify, and approve a pharmaceutical product to enhance the GMP within the industry. The book is written with the idea of providing basic knowledge to undergraduate students who are preparing to enter the industry at the end of their graduation. The book would also be beneficial for institutions conducting pharmaceutical technology study courses in terms of GMP and GLP applications. Features: Provides readers and front line health care product manufacturers, all the information they need to know to develop a GMP oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. Provides stepwise guidance on how to evaluate, audit, qualify, and approve a pharmaceutical product and packaging material to enhance the GMP within the industry. Includes significant processes and steps in production for all common dosage forms. Explains how in‐process and finished products are released. Provides an ideal and effective tool for anyone starting Quality Assurance/Quality control/Production responsibilities.

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Page Count

267

Publisher

CRC Press

Published Date

ISBN 10

1003856349

ISBN 13

9781003856344

Pharmaceutical Vendors Approval Manual

A Comprehensive Quality Manual for API and Packaging Material Approval

By: Erfan Syed Asif

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Pharmaceutical Vendors Approval Manual

A Comprehensive Quality Manual for API and Packaging Material Approval

By: Erfan Syed Asif

This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications. This book provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements covers basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry provides ready to use regulatory documentation, e.g. letter of commitment, questionnaire, SOP, etc. required for API and Packaging Materials contract Provided material can be easily tailored to incorporate changes to add in-house vendor’s qualification requirements. Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.

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Page Count

110

Publisher

CRC Press

Published Date

ISBN 10

1000510026

ISBN 13

9781000510027

Quality Control Training Manual

Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

By: Syed Imtiaz Haider,Syed Erfan Asif

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Quality Control Training Manual

Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

By: Syed Imtiaz Haider,Syed Erfan Asif

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences

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Page Count

484

Publisher

CRC Press

Published Date

ISBN 10

143985016X

ISBN 13

9781439850169

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

By: Syed Imtiaz Haider,Erfan Syed Asif

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Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

By: Syed Imtiaz Haider,Erfan Syed Asif

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Solve jigsaw puzzle

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Page Count

586

Publisher

CRC Press

Published Date

ISBN 10

1439886903

ISBN 13

9781439886908

Book's by Erfan Syed Asif

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Basics of Pharmaceutical Manufacturing and Quality Operations

Basics of Pharmaceutical Manufacturing and Quality Operations

Pharmaceutical Vendors Approval Manual

Pharmaceutical Vendors Approval Manual

Quality Control Training Manual

Quality Control Training Manual

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

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