The Essential Equations and Formulas for Cleaning Validation
1. Acceptance Value (AV) calculation formula: AV = (Σ |C - T|) / n x 100 where AV is the accepta…
1. Acceptance Value (AV) calculation formula: AV = (Σ |C - T|) / n x 100 where AV is the accepta…
There are several quality risk management trends in the pharmaceutical industry that have emerged i…
As a life science sector audit and inspection are common terms in pharmaceutical industry. Here we …
pH and pKa are two important concepts in chemistry that are often confused. pH pH is a measure of t…
“In many organization, politics are allowed to influence the CAPAs simply because there are too man…
Non-sink conditions refer to situations where the concentration of the drug substance in the dissol…
Sink conditions refer to a state in which the dissolution medium has sufficient volume to ensure t…
In Europe, The EMA coordinates the assessment of reports of product quality defects of centrally au…
Corrective and Preventive Action (CAPA) was first formally introduced by the U.S. Food and Drug Adm…
Root Cause Analysis (RCA) is a problem-solving methodology that steps you through the RCA process. …
Cleaning validation is a regulatory requirement in pharmaceutical industry. It ensures that the cle…
Pharmaceutical tablets must meet their physical specifications and quality standards for ensuring s…
Tablet is the most common and convenient dosage form. It contains active ingredient(s) and excipien…
To ensure the quality of the drugs produced, strict guidelines and regulations shall be in place an…
GMP stands for Good Manufacturing Practices in pharmaceuticals, it means to follow the regulatory s…
The main similarities and differences between Quality Control (QC) and Quality Assurance (QA) are a…
Elaboration ICH stands for: International conference on harmonization of technical requirements f…
ALCOA+ is an acronym that stands for Attributable, Legible, Contemporaneous, Original, Accurate, a…
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human…