ABSTRACT
Why validate? Though validation is a well-accepted and recognized cGMP requirement in today’s Pharma business, this question is often posed during the product or process development (PD) activities in a start-up or even in an established company. In a nutshell, validation is not only a regulatory requirement, but it makes ‘‘good business sense.’’ Validated processes assure production of quality product, batch after batch, and ultimately result in fewer headaches down the road in terms of fewer deviations during production, quality assurance (QA) discrepancy investigations, adverse events from the field, and regulatory observations (483s and its global equivalent) during regulatory inspections. In addition, they improve cost effectiveness in terms of preventing process failures, lot rejections, re-processing of salvageable lots, and attaining maximum plant capacity. Moreover, a sound and thorough validation strategy not only assures the production of top quality products, but also builds confidence and provides peace of mind to its customers. It also boosts the morale of the company employees and help build a sound and trustworthy relationship and track record with the regulatory agencies. The latter may come as a blessing for a company’s future dealings with the regulatory agencies.
