Cell Therapy: cGMP Facilities and Manufacturing

Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library.

Additional topics in Cell Therapy: cGMP Facilities and Manufacturing…

Standard operating procedures
Supply management
Facility equipment
Product manufacturing, review, release and administration
Facility master file

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Calibration in the Pharmaceutical Laboratory

Increasingly, pharmaceutical scientists must not only be specialists in their field but must also be familiar with legislation that governs the use of equipment in their industry. The regulation of test and measuring equipment changes continually as new regulations are introduced and new equipment is developed. Calibration in the Pharmaceutical Laboratory provides general background on laboratory balances and precision scales, insight into mass measurements and associated errors, and detailed information on key quality issues associated with weighing. Managers responsible for QC and QA will find this book an invaluable tool when setting out SOPs for balances and scales used throughout the manufacturing and testing process.

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Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries,

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.

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Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United States. The lack of well defined validation standard operating procedures may result in adverse FDA findings, recalls, and heavy financial losses. Key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation do not describe exactly how to develop a master validation plan, how to achieve compliance, or the standard operating procedures and documentation required.
This text provides the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry. The text and CD are designed to minimize workload and optimize time, money, and resources. A comprehensive when-and-how-to-do-it guide, Validation Standard Operating Procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States.

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