PHARMACEUTICAL QUALITY DURING PRODUCT LIFE CYCLE – A NEED OF HOLISTIC APPROACH

Nirmal Kumar* and Prof. Ajeya Jha

ABSTRACT

The famous quote- “Quality is not inspected rather it is inbuilt”, suits perfectly in case of pharmaceutical business. Quality is the most vital aspect of medicines and hence pharmaceutical business. Once the pharmaceutical product is in market, there is no scope to rectify the defects at the users end; hence it becomes imperative to evaluate the quality of pharmaceutical product, during its life cycle. A pharmaceutical quality professional has to evaluate the product starting from its development stage up to delivered to patients. The pharmaceutical products are manufactured in batches (batch size ranging up to billion) and if defect is prevalent in one unit of product there is probability that it would affect the billions of consumers. Ideally, the pharmaceutical products should be designed properly, monitored during production process and care should be taken during distribution to protect the quality attributes to undergo any unforeseen deterioration. Quality by design (QbD) and further operation under aegis of Quality Risk Management (QRM) are the safest techniques in pharmaceutical world. Standard Operating Procedures (SOP) and adequate training to professions across the product life cycle is the key to deliver quality product. To ensure quality products consistently, the stake holders of pharmaceutical business should possess a holistic approach during all three stages of pharmaceutical business – Product Development, Good Manufacturing and Distribution in market.

Keywords: Pharmaceutical Quality System, Product Quality Life Cycle, CGMP, ICH, USFDA, QbD.