Quality Operations Procedures for Pharmaceutical, API, and Biotechnology: 1st Edition (Hardback) book cover

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

1st Edition

By Syed Imtiaz Haider, Erfan Syed Asif

CRC Press

584 pages | 6 B/W Illus.

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Hardback: 9781439886908
pub: 2012-06-06
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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

About the Authors

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.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Biotechnology
MEDICAL / Pharmacology