Preventive Maintenance in Pharmaceutical Industry Preventive maintenance in pharma is a planned, systematic approach to maintaining equipment, utilities and facilities so they remain in a qualified, reliable and GMP-compliant state. Instead of waiting for failures to happen, activities are scheduled…
A User Requirement Specification (URS) is a formal document that outlines the needs of a user for a system, product, or service. In the pharmaceutical industry, a URS is a crucial document that ensures that equipment, processes, or systems meet regulatory standards…
The URS is a definition of requirements to fulfil the demands of the process from the Users’ point of view. The success of a GMP clean room design is dependent on a clear and concise User Requirement Specification (URS) to take…
Oncology in Pharma – Complete Overview Oncology is the branch of medicine that deals with the prevention, diagnosis and treatment of cancer. In pharmaceuticals, oncology is one of the most active and fast-growing therapeutic areas, with hundreds of new drugs,…
A User Requirement Specification for DPI is a formal document that defines the requirements for using a system in a regulated environment, such as a pharmaceutical facility. It’s a living document that can be updated as requirements change and is typically prepared…
What Is a URS for Ointments in Pharma? A User Requirement Specification (URS) for ointments is a formal document that defines what the end user expects from equipment, systems and facilities used to manufacture, store and pack semi-solid products (creams,…
A placebo is a “physiologically inert substance or sham intervention (psychological, physical or mechanical) which produces beneficial effects independent of any direct therapeutic effects”. The positive effects occur as a result of a patient’s expectations rather than as a result of a causative…
Occupational Exposure Level (OEL) is the maximum airborne concentration of a substance (usually an API or potent intermediate) that workers can be exposed to, safely, during their normal working day. In simple terms, OEL tells you “how much is too…
Lyophilizer Qualification in Pharma is an important aspect in pharma. Lyophilization, also known as freeze-drying, is a process used to preserve a perishable material or make it more convenient for transport. It works by freezing the material and then reducing…
1. Process Design (Stage 1) Goal: Design and understand the cleaning process so it can consistently remove product, detergent, and microbial residues to an acceptable level. Key activities: 2. Process Qualification / Validation (Stage 2) Goal: Demonstrate and document that…