ABSTRACT
The following chapter provides a perspective on a
general approach to validation activities in a small
pharmaceutical company. As a small company with a
focus on contract manufacturing, Lyne Laboratories has
successfully completed validation on numerous ANDAs,
NDAs and OTC products. Our approach to validation
meets the highest industry and regulatory standards and
has consistently and effectively been used with small,
large and virtual pharmaceutical companies. For Lyne
Laboratories and other small companies, validation is
both challenging and rewarding. While it often taxes
resources and demands intense and broad-based
management involvement, it can also stimulate peak
performance from the team and individuals within the
company. As a crucial component in pharmaceutical
manufacturing, managing the validation process requires
leadership skills in addition to technical and scientific
competency.