Pharma SOPs is used as a tool for providing a proper and systematic way to follow all rules and regulation under controlled manners in pharmaceutical industries. The quality assurance department reviews all SOPs before the distribution to the department. Read here the list of all Quality Assurance SOPs. List of all SOPs Related to Quality … Read more
There is often confusion surrounding the terms validation, calibration, and qualification within the pharmaceutical industry. Let’s explore their differences with explanatory examples. Difference among Validation, Calibration, and Qualification 1. Qualification: Qualification is the process of planning, conducting, and documenting test results performed on equipment to confirm its operational capability. It demonstrates that the equipment will … Read more
Pharmaceutical products are generally contaminated by microorganisms, cleaning agents, or other materials, But in many cases, it may be due to the repeated use of the same equipment for processing. To avoid this problem FDA introduced the Cleaning method validation process for pharmaceutical industries. The cleaning procedure must be strictly followed to execute the cleaning method. Normally … Read more
Validation is the established document evidence or proof that provides a high degree of assurance. A particular method can systematically produce a product that meets its predetermined specifications and quality attributes. Process validation is also a component of the validation, which is explained below. Introduction to Pharmaceutical Validation: The Importance of Validation in Pharmaceutical Validation … Read more
Standard Operating Procedure for Acceptable Quality Level (AQL) includes; Purpose, Scope, Responsibility, Precautions, Procedure, Classification of Defects for AQL, and AQL Charts. 1.0 Purpose: To lay down the standard procedure for an acceptable quality level for semi-finished tablets to evaluate physical attributes before packing. 2.0 Scope: This sop is applicable to all tablet products manufactured at the … Read more