What is RFAR in Europe? RFAR stands for Rapid Field Alert Report. In EU terminology it’s directly linked to FSCA – Field Safety Corrective Action for medicinal products. Definition: An urgent communication to Competent Authorities and customers regarding actions taken to reduce risk of a defective medicinal product already on the market. Key EU Regulations … Read more
Risk Management in Pharma: ICH Q9 R1 Guide + 7 QRM Tools 2026 Quality Risk Management QRM is no longer optional in pharma. ICH Q9 R1 makes it mandatory across product lifecycle – from development to commercial manufacturing. But 80% of QA teams still do risk assessment as “copy-paste” exercise. Result: USFDA 483 for “Risk … Read more
Typically, it is anticipated that process validation should be finalized before the distribution of a finished product intended for sale (prospective validation). In cases where this is not feasible, it may be essential to validate processes during regular production (concurrent validation). Additionally, processes that have been operational for a considerable duration without any major modifications … Read more
The extent and intricacy of a qualification exercise are often connected to the complexity of the equipment in question and the essential role that equipment plays in ensuring the quality of the final product. Installation and operational qualification exercises guarantee, through suitable performance tests and accompanying documentation, that the equipment, along with its ancillary systems … Read more
A validation master plan is a document that encapsulates the company’s overarching philosophy, objectives, and strategies for determining performance adequacy. It is essential that the validation master plan receives approval from management. Validation generally necessitates thorough preparation and careful planning of the different stages involved in the process. Furthermore, all tasks should be executed in … Read more
A pharmacopoeia constitutes a legally enforceable compilation of standards and quality criteria for medications utilized within a specific country or region. The term “Pharmacopoeia” was first used as a specific title in a publication from Basel, Switzerland, in 1561 by Dr. A. Foes, although it did not gain widespread usage until the early 17th century. … Read more
What is a Material Safety Data Sheet, commonly referred to as MSDS? A material safety data sheet (MSDS) is a documented resource that supplies users and emergency responders with essential information and procedures for the safe handling and use of chemicals. MSDSs have existed in various forms since the era of the ancient Egyptians. While … Read more
Amorphous: A term that refers to a solid lacking a crystalline structure. Although there may be some local arrangement of atoms or molecules within an amorphous solid, there is an absence of long-range order. Examples include window glass and polystyrene. Atomic mass unit: An atomic mass unit, abbreviated as amu, is defined as one twelfth … Read more
A tablet’s strength has a significant impact on its marketing, transportation and dissolution. The mechanical strength of tablet or granules can be determined by its hardness and through friability test. A clear synthetic polymer drum with polished internal surfaces that is not susceptible to static buildup shouldbe used; it should have an internal diameter of 283 to 291 mm and a depth of 36 to 40 mm. The drum has a detachable side. A curving projection that runs from the center of the drum to the outside wall and has an inside radius of 75.5 to 85.5 mm tumbles the tablets with each rotation of the drum. A device that revolves at 25 ±1 rpm has the drum fixed to its horizontal axis. As a result, the tablets slide or roll during every rotation, landing on the drum wall or one another. Friability test procedure and Acceptance Criteria
What exactly is a Blister Pack? Blister packaging is a process that entails shaping a heat-softened plastic film into deep-drawn pocket molds to create a tray (thermoforming), followed by filling it with a solid dosage form product and sealing it with either a push-through or peelable cover. Adequate heat and pressure must be applied to … Read more
