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-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.

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.

Handling of Sampled MaterialControl of Incoming Materials used in ProductionControl of Bulk and Intermediate ProductsChecking of Finished ProductsDestruction of Disposal Samples after Complete Testing and Reference Samples after ExpiryRecording the Analysis and Controlling the Analytical Registers and RecordsTesting of Finished ProductsMicrobiological Monitoring ProgramClothing in Microbiology LaboratoryMicrobiological Media HandlingGeneral Cleaning and Sanitation of Microbiological LaboratoryManaging Primary and Secondary Reference Standards in theQuality Control LaboratoryHandling of Raw/Packaging Materials and Finished Samples in Reference RoomStability Testing ProgramControl of Controlled Substances (Raw Material, Bulk and Finished Products)Rounding of Significant NumbersAnalytical Methods Transfer for New ProductsHandling Out of Specification ResultsBatch Auditing ProcedureValidation and Certification GuidelinesProduct Complaints Handling ProcedureSampling of Finished Products for Laboratory TestingSampling of Bulk Products for Laboratory TestingProduct Recall ProcedureCream/Ointment In-process Audit ChecksInspection of Physical Attributes/Characteristics of Coated/Uncoated TabletsPowder In-Process Filling Audit ChecksSealing Checks of Strips and BlistersTablets Compression Audit ChecksIn-Process Checks for Finishing LinesInternal QA Audit GuidelineSuppository Fill Weight and Physical Attributes CheckTablets/Capsule Filling In-Process Audit ChecksPhysical Inspection of Attributes of CapsulesCapsules In-process Audit ChecksLiquid Products In-Process Audit ChecksDocument Security & Control and Good Documentation GuidelinesLabeling for Incoming Materials, In-Process Products and Complete Processed ProductsPre-Inspection Audit Guidelines for ANDA ProductsOperational Qualification GuidelineThe Retention of Records and DocumentsGood Manufacturing Practices in the PremisesLabeling for Incoming Materials, In-Process Products and Complete Processed ProductsRandom SamplingPhysical Characteristics Check of Product and Foil during SealingRaw Material QA Audit ChecksIncidence Citation ReportTechnical Documents Distribution ControlKey Performance IndicatorVendor Evaluation and Approval Procedure