Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

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-

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. Label

About the Author :
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 Canadaa 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.