Quality Operations Procedures for Pharmaceutical, API, and Biotechnology  book cover
1st Edition

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

ISBN 9781439886908
Published June 6, 2012 by CRC Press
584 Pages - 6 B/W Illustrations

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Book Description

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.

Table of Contents

Handling of Sampled Material
Control of Incoming Materials used in Production
Control of Bulk and Intermediate Products
Checking of Finished Products
Destruction of Disposal Samples after Complete Testing and Reference Samples after Expiry
Recording the Analysis and Controlling the Analytical Registers and Records
Testing of Finished Products
Microbiological Monitoring Program
Clothing in Microbiology Laboratory
Microbiological Media Handling
General Cleaning and Sanitation of Microbiological Laboratory
Managing Primary and Secondary Reference Standards in the
Quality Control Laboratory
Handling of Raw/Packaging Materials and Finished Samples in Reference Room
Stability Testing Program
Control of Controlled Substances (Raw Material, Bulk and Finished Products)
Rounding of Significant Numbers
Analytical Methods Transfer for New Products
Handling Out of Specification Results
Batch Auditing Procedure
Validation and Certification Guidelines
Product Complaints Handling Procedure
Sampling of Finished Products for Laboratory Testing
Sampling of Bulk Products for Laboratory Testing
Product Recall Procedure
Cream/Ointment In-process Audit Checks
Inspection of Physical Attributes/Characteristics of Coated/Uncoated Tablets
Powder In-Process Filling Audit Checks
Sealing Checks of Strips and Blisters
Tablets Compression Audit Checks
In-Process Checks for Finishing Lines
Internal QA Audit Guideline
Suppository Fill Weight and Physical Attributes Check
Tablets/Capsule Filling In-Process Audit Checks
Physical Inspection of Attributes of Capsules
Capsules In-process Audit Checks
Liquid Products In-Process Audit Checks
Document Security & Control and Good Documentation Guidelines
Labeling for Incoming Materials, In-Process Products and Complete Processed Products
Pre-Inspection Audit Guidelines for ANDA Products
Operational Qualification Guideline
The Retention of Records and Documents
Good Manufacturing Practices in the Premises
Labeling for Incoming Materials, In-Process Products and Complete Processed Products
Random Sampling
Physical Characteristics Check of Product and Foil during Sealing
Raw Material QA Audit Checks
Incidence Citation Report
Technical Documents Distribution Control
Key Performance Indicator
Vendor Evaluation and Approval Procedure

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Syed Imtiaz Haider, Ph.D. is a quality assurance and environmental specialist with over 20 years of experience in aseptic and nonaseptic pharmaceutical processes, equipment validation, and in-process control and auditing. Dr. Haider is currently involved in several major biotechnology-based tasks, including cell-line qualification, process validation, biological analysis, method validation, biosimilars comparative studies, organizing preclinical studies, and preparation of the Central Technical Dossier (CTD) formatted for regulatory submission. He is the author and coauthor of more than 20 research publications in international refereed journals dealing with products of pharmaceutical interest, their isolation, and structure development.

Erfan Syed Asif, Ph.D. has over 17 years of experience in various areas of quality operations in pharmaceutical industries in Pakistan, the United States, Canada, and the UAE. He has worked in US FDA- and Health Canada–approved facilities in managerial positions under the quality operations umbrella. He has extensive experience in overseeing qualification projects for manufacturing equipments, utilities, systems, sterilization techniques, aseptic processes simulation test, and the sterile and nonsterile products manufacturing process.

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