Pharmaceutical manufacture design

Process validation is the procedure that allows one to establish the critical operating parameters of a manufacturing process. Hence, the constraints imposed by the FDA as part of process control and validation of an SMB process. The total industrial SMB system, as described, is a continuous closed-loop chromatographic process, from the chromatographic to recycling unit and, with the use of numerical simulation software allows the pharmaceutical manufacturer rapidly to design and develop worst-case studies. 

In the design of equipment for the manufacture of sterile ophthalmic (and nonophthalmic) pharmaceuticals, manufacturers and equipment suppliers are turning to the advanced technology in use in the dairy and aerospace industries, where such concepts as CIP (clean-in-place), COP (clean-out-of-place), automatic heliarc welding, and electropolishing have been in use for several years. As a guide here, the reader is referred to the so-called 3A Standards of the dairy industry issued by the U.S. Public Health Service [267],... 

Pharmaceutical Manufacturers Association (PMA). (1988). Results of a Questionnaire Involving the Design of and Experience with Carcinogenicity Studies. This document has not been published in the open literature but is widely available within the pharmaceutical industry. It may be obtained by writing to the Pharmaceutical Manufacturers Association, Washington, DC. 

According to 211.113 Control of microbiological contamination, pharmaceutical manufacturers need written procedures describing the systems designed to prevent objectionable microorganisms in both nonsterile and sterile drug products. All sterilization processes used to manufacture parenteral drugs need to be validated. 

To provide the qualification design guide line for the HVAC design of pharmaceutical manufacturing plant... 

This book was designed and written for validation professionals responsible for writing and maintaining quality management systems for the successful operation of their companies. It provides a set of SOPs that can be used to manage and document critical validation and revalidation tasks in a pharmaceutical manufacturing facility. 

Pharmaceutical manufacturing operations are inefficient and costly. The cost of low efficiency is generally not understood or appreciated (e.g., manufacturing costs far exceed those for research and development operations). Low efficiency is predominantly due to self-imposed constraints in the system (e.g., static manufacturing processes, focus on testing as opposed to quality by design, approach to specifications based on discrete or the so called zero tolerance criteria, a less than optimal understanding of variability, etc.). These constraints keep the system in a corrective action mode. 

ANALYTICAL AND COMPUTATIONAL METHODS AND EXAMPLES FOR DESIGNING AND CONTROLLING TOTAL QUALITY MANAGEMENT PHARMACEUTICAL MANUFACTURING SYSTEMS... 

Flexible Pharmaceutical Manufacturing and Assembly System Design... 

Pharmaceutical manufacturing system design methods and tools with examples... 

Process modeling for designing and running pharmaceutical manufacturing... 

FLEXIBLE PHARMACEUTICAL MANUFACTURING AND ASSEMBLY SYSTEM DESIGN... 

The key objective of this chapter is to describe a generic and systematic pharmaceutical manufacturing/assembly system design method that includes product, process, service systems, and even innovation project management architecture aspects of such systems. 

A pharmaceutical manufacturing system design requires significant level of innovation. The broadest definition of innovation is the act of introducing something new to a society or community, whether a product or process. This is often confused with invention, which focuses more on specific objects. Within pharmaceuticals innovation can therefore include new business structures within the company,... 

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