Qualification
Qualification of HPLC | A Complete Guide
The HPLC qualification process consists of four parts: Design Qualification (DQ) Design qualification (DQ) describes the user requirements and defines the functional and operational specifications of the instrument. It should ensure that instruments to be purchased have the necessary functions and performance that will enable them be suitable for the ... Read More
Why Change Management is Important during CQV?
Change management is crucial in any Commissioning, Qualification, and Validation (CQV) activity within the pharmaceutical and other regulated industries for several important reasons: Robust change management helps ensure compliance, manage risks, maintain product quality, and facilitate efficient and controlled change implementation. It is an integral part of maintaining the quality, ... Read More
Commissioning, Qualification, and Validation (CQV) in Pharmaceutical Industry
Commissioning, Qualification, and Validation (CQV) is one of the most important phases in achieving cGMP and regulatory compliance for a pharmaceutical manufacturing facility. CQV is a systematic approach to ensuring that facilities, equipment, and processes meet the required quality and regulatory standards. Each phase serves a specific purpose in the ... Read More
Difference Between Calibration and Qualification
A list of differences between calibration and qualification are mentioned below: Similarities Read also:
Validation and Qualification In Pharmaceutical Manufacturing
What is Validation? As per EU GMP – It is “Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to expected results. What is Qualification? Comparison between Qualification and Validation Why Validation? What to Qualify/Validate? ... Read More