Contract Manufacturing - Quality Assurance Role


Huxsoll, Jean   (1991, ASQC)   Applied Immune Sciences, Menlo Park, CA

Annual Quality Congress, Milwaukee WI    Vol. 45    No. 0
QICID: 9599    May 1991    pp. 19-24
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Article Abstract

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:

  1. Establish limitations and/or requirements;
  2. Approve advertising/marketing literature;
  3. Establish services and capabilities to be offered;
  4. Set internal guidelines;
  5. Set external guidelines;
  6. Be an active decision maker in initial negotiations;
  7. Be honest and open during initial discussions, production and release;
  8. Compile list of documentation for final packet;
  9. Participate in development of time line;
  10. Determine responsibilities for discrepant lots, compliant investigations and recall activities;
  11. Audit manufacturing of product;
  12. Disposition lot;
  13. Compile and send lot packet information;
  14. Resolve outstanding issues.


Biomedical,Contracts,Negotiations,Quality assurance (QA)

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