Dear Pharma Pals,

The pharmaceutical industry is under increasing pressure to adopt Good Manufacturing Practices and produce high- quality products. However, many companies have failed to properly implement “Schedule M”, leading to issues during inspections of manufacturing plants and public testing labs. These issues include poor documentation, lack of process and analytical validations, absence of quality failure investigation, absence of internal product quality review, and faulty design of manufacturing and testing areas, among others. To address these concerns, the magazine has highlighted the “Top Trending Drug GMP Issues”. Good Manufacturing Practices (GMP) is a system that ensures products are manufactured and controlled according to quality standards to minimize risks associated with pharmaceutical manufacturing. GMP is a part of a quality management system that ensures products are manufactured and controlled to quality standards that meet their intended use and market approval requirements. The article also discusses the importance of hygienic design for pumps, seals, and valves, as well as quality by-design and its regulatory implications.

Last the most important to increase production and minimize downtime cost-effectively and efficiently, multi- tip tooling is the way to go. Although it may be seen as modern, multi-tip tools have actually been used since tablet presses emerged. Single-station presses used to dominate production, yet they could not keep up with the growing demand due to their limited tooling stations.

Harjit Singh Dhaul
Publisher & Editor