Introduction When line clearance is not performed, not documented properly, or done ineffectively, it poses significant risks, including: Line clearance is especially critical during product changeover, batch initiation, format part changes, and shift transitions. It must be conducted by trained…
Introduction In solid oral dosage form manufacturing, dies and punches are critical tooling components used in the tablet compression process. These components directly impact the shape, size, weight, hardness, and uniformity of tablets. Their condition and performance must be tightly…
Introduction In pharmaceutical manufacturing, primary packaging materials are those that come into direct contact with the drug product, such as bottles, blister foils, tubes, vials, caps, stoppers, and laminates. These materials play a crucial role in protecting the product from…
Introduction: In pharmaceutical manufacturing, primary packaging plays a vital role in preserving the stability, efficacy, and safety of the final product throughout its shelf life. For semisolid dosage forms such as ointments, creams, and gels, aluminium tubes are widely used…
Introduction In pharmaceutical manufacturing, particularly in aseptic processing, personnel are a significant source of contamination. The human body continuously sheds skin particles and microorganisms, which can compromise sterile environments if not properly controlled. Gowning procedures, therefore, are critical barriers that…
Introduction Certain pharmaceutical products are inherently light-sensitive, meaning they degrade or lose potency upon exposure to light, especially UV and visible wavelengths. This sensitivity can affect both active pharmaceutical ingredients (APIs) and finished dosage forms, resulting in chemical instability, loss…
Introduction In the pharmaceutical industry, maintaining appropriate storage conditions is critical at every stage of the product lifecycle—from raw material receipt and in-process storage to finished goods warehousing and distribution. Temperature, humidity, light exposure, and cleanliness are key environmental parameters…
Introduction Standard Operating Procedures (SOPs) are a fundamental component of the pharmaceutical quality system. They define standardized, repeatable methods for performing operations in compliance with Good Manufacturing Practices (GMP), ensuring consistency, traceability, and control across all manufacturing, laboratory, and quality…
Introduction The Annual Product Quality Review (APQR) is a critical quality management activity mandated by global regulatory authorities including the US FDA, EU GMP (Annex 15 & 16), WHO, and ICH Q10. The purpose of the APQR is to systematically…
Introduction: Quality Assurance (QA) is a foundational element of pharmaceutical manufacturing, responsible for establishing, monitoring, and enforcing systems that ensure product quality, safety, and regulatory compliance. QA functions encompass a wide range of activities, including documentation control, deviation management, batch…
Introduction: In pharmaceutical manufacturing environments, the selection and maintenance of flooring systems are critical to ensuring compliance with Good Manufacturing Practices (GMP). Epoxy flooring is widely used in cleanrooms, production areas, and packaging zones due to its seamless finish, chemical…
Introduction: Drains in pharmaceutical manufacturing areas play a crucial role in managing wastewater, preventing backflow, and maintaining sanitary conditions. However, if not properly designed, maintained, or monitored, GMP (Good Manufacturing Practice) drains can become significant sources of contamination—posing a risk…