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.