HORMONES QUALIFICATION IN PHARMA
Post Views: 1,849 A Hormone is defined as a chemical released by a cell or a gland in one part of the body that sends out messages that affect cells in other parts of the organism. Only a small amount of…
Chemical SOP
Microbiology SOP
Warehouse SOP
Manufacturing SOP
Information technology SOP
HAZARD IDENTIFICATION AND RISK ASSESSMENT IN PHARMA
Post Views: 3,326 HIRA (Hazard Identification and Risk Assessment) is a structured method for detecting and evaluating hazards in process facilities HIRA detects potential risks that may cause accidents, injuries, or environmental damage.
SOP FOR PREVENTIVE MAINTENANCE IN PHARMA
Post Views: 6,233 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,…
USER REQUIREMENT SPECIFICATION FOR OPHTHALMIC IN PHARMA
Post Views: 2,617 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…
USER REQUIREMENT SPECIFICATION FOR AMPOULES IN PHARMA
Post Views: 2,304 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…
ONCOLOGY QUALIFICATION IN PHARMA
Post Views: 1,679 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…
USER REQUIREMENT SPECIFICATION FOR DPI
Post Views: 2,630 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…
USER REQUIREMENT SPECIFICATION FOR OINTMENTS IN PHARMA
Post Views: 3,058 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…
PLACEBO IN PHARMA
Post Views: 2,450 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…
OCCUPATIONAL EXPOSURE LEVEL (OEL) IN PHARMA
Post Views: 4,905 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…
LYOPHILIZER QUALIFICATION IN PHARMA
Post Views: 5,133 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…
Cleaning Validation Life Cycle in Pharma
Post Views: 3,711 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…