About the Book

The Cleaning Validation Manual provides technical solutions in both text and electronic form that fulfill the training needs of finished pharmaceutical manufacturers, active and nonactive pharmaceutical manufacturers, biopharmaceutical manufacturers, biotechnology contract laboratories, bioresearch and development laboratories, universities, and institutions offering cleaning validation courses and training.

The Cleaning Validation Manual with the CD-ROM is a valuable tool for both existing and new biotech manufacturers, finished pharmaceutical manufacturers, and active/nonactive API manufacturers. It is equally relevant to formulators, research and development managers, manufacturing production supervisors and operators, and quality assurance personnel involved in process realization.

The manual provides exclusive training guidelines in electronic form on a CD-ROM for customer convenience. This enables users to amend or adopt them with or without reinventing the wheel, thus resulting in time-saving and optimal resource utilization.

The ready-to-use Cleaning Validation Manual is based on general principles of cleaning and techniques provided on CD-ROM so that customers can input them into their computers and use their own Microsoft Word® program to edit and print these documents. The contents are written in simple language. The book will help to minimize the amount of effort, to avoid the nightmare of validation managers, development managers, production managers and R&D personnel trying to meet the regulatory training requirements within optimal time establishing in-house training programs. The Cleaning Validation Manual provides hands-on training information based on the current approach to using the appropriate technique effectively. It refers exclusively to principles and techniques applicable in the pharma industry and ensures product quality, potency, efficacy, and safety. Specific formats are used to describe the concepts step by step to ensure that the electronic files can be easily used worldwide with a diversified range of organizations involved in pharma and biopharmaceutical development, manufacturing operations, research & development, academic teaching, and professional development. Twenty-four cleaning protocol templates along with the cleaning procedures and more than 200 APIs with their toxicity and solubility levels have further added value to the book.

It is true that over the last few decades there has been significant advancement in the development of biopharmaceuticals. However, there is no single book that provides all of the following:

• A valuable ready-to-use cleaning validation manual

• Time saving for validation professionals

• Development of skilled manpower

• Ready-to-use cleaning validation master plans and procedures

• Cleaning procedure templates for over 20 extensively used pieces of manufacturing equipment

• Templates for the 12 most commonly used equipment in solid dosage form

• Templates for the 6 most commonly used equipment in liquid dosage form

• Templates for the 6 most commonly used equipment in the sterile area

• Matrix of toxicity and water solubility for over 200 APIs

• Reference to international regulatory compliance

• Reduced product development failures

• Prevention of reinventing the wheel

• Optimization of research expenses

• Avoidance of marketing delays

• Marketing edge over competitors

• Avoidance of incidental cross-contamination

• Improved company credibility

• Uninterrupted product supply

• Positive public opinion

• Improved process product safety

• Reduced product recalls

• Sampling tools for cleaning validation

The Cleaning Validation Manual is primarily written in a global context and can be beneficial to any industry interested in the development and manufacture of new APIs and to biosimilar and finished pharmaceutical manufacturers.

This book may be purchased for the following reasons:

• It provides readers and frontline healthcare products manufacturers, R&D management, and biotech laboratories with all the information they need to make a successful cleaning validation master plan and apply it.

• It is a simple, concise, and easy-to-use reference tool covering basic concepts and the elements of training required by educational institutions and professional certification bodies.

• The text (and CD-ROM) is a valuable time saver for companies that are in the process of developing manpower in order to achieve consistency in their operations.

• The topics provided in the CD-ROM can be easily tailored to incorporate changes of in-house training requirements.

• The topics provide stepwise guidance on how to train new and existing staff on cleaning concepts and increase awareness.

The Cleaning Validation Manual has the following advantages:

• It has been tested with proven results.

• It has been formally organized and published as a tool for the healthcare industry, covering diversified topics related to the cleaning validation master plan.

• It minimizes workload and increases efficiency.

• It does not merely provide guidelines or thought processes, but rather gives ready-to-use templates to develop master plans, SOPs, and validation protocols.

• It enables manufacturing companies to avoid hiring consultants for development of a cleaning validation master plan, worst-case matrices and protocols, and ultimately eliminating consulting fees.

• It serves as a single source to achieve and maintain a successful cleaning validation program.

• It is a practical guide that educates new and existing staff involved in routine operations.

• It is written in a global text and can serve as an effective tool for beginners.

• It reinterprets the list of specifics that need to be addressed to obtain a successful cleaning validation program.

• It provides an accurate and meaningful understanding of cleaning and the healthcare industry.

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