Darshan Singh

Darshan Singh

Author is a pharmaceutical quality and regulatory professional with more than 23 years in drug manufacturing. He holds an M.Sc. in Organic Chemistry and a Diploma in Pharmacy. He has served as Quality Control Head, Quality Assurance Head and Plant Head, overseeing all manufacturing operations. He is co-founder and regulatory consultant at Laafon Galaxy Pharmaceuticals. He writes on SOPs, manufacturing processes, Schedule M compliance and drug pharmacology, and checks each claim against pharmacopoeial and regulatory sources.

Basic requirements for Process Validation exercises

The pharmaceutical industry is the most highly regulated industry in the world. Every pharmaceutical manufacturing company has to face various audits by the Drug department and other players. To comply with the requirements of audits companies have to prove that…