Huxsoll, Jean (1991, ASQC) Applied Immune Sciences, Menlo Park, CA
This abstract is an edited version of the authors' original.
The author conducted a survey of 344 biotechnology firms, covering various product types, manufacturing methods, and quality functions. This article provides an overview of biotechnology methods and the roles and responsibilities that quality assurance must take with contract manufacturing.
There is an increasing need for companies to go to contract manufacturers to produce their first clinical material and possibly their first production lots. The cost effectiveness is dependent upon the product and the size of the company. This approach affords a new direction and responsibility quality assurance, both for the company developing the product and for the company that will be performing the contract manufacturing.
The article provides a thorough description of the quality assurance responsibilities for each step involved in contract manufacturing:
Biomedical,Contracts,Negotiations,Quality assurance (QA)