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…
Key Points for Applying QRM Tools in Pharma Cleaning Programs Applying Quality Risk Management (QRM) tools to cleaning programs helps pharma companies design and maintain risk-based, scientifically sound and compliant cleaning strategies. Instead of treating all products, equipment and residues…
A Visible Residue Limit (VRL) is the maximum amount of residue on a product-contact surface that is just visible to the unaided eye under defined viewing conditions. It is mainly used to support visual inspection as a verification tool, to…
Establishing process parameters for a manual cleaning process in cleaning validation means defining, controlling, and justifying the key variables that ensure consistent removal of product residues and cleaning agents from equipment. Because manual cleaning depends heavily on operator technique, parameters…
A cleaning validation roadmap is the stepwise plan used to prove equipment cleaning consistently meets predefined acceptance criteria and stays in control throughout routine production. 1) Define scope and build the equipment matrix List all equipment trains and product-contact parts.…
HISTORY OF CLEANING VALIDATION IN PHARMA Cleaning validation in the pharmaceutical industry grew gradually out of broader process validation and GMP expectations: In summary, the history of cleaning validation in pharma shows a clear evolution:from informal cleaning and simple visual…
Analytical method validation in Pharma is a critical process in the development and implementation of methods used for data analysis in various scientific disciplines, including pharmaceuticals, environmental monitoring, food and beverage testing, and clinical diagnostics. This process ensures that the…