December 26, 2022
Managing Risk Through Change
Managing Risk Through Change Managing Risk Through Change As the pharmaceutical industry continues to face changes in regulations and adapt to new technologies, it is important for organisations within this field to understand the importance of managing risk through these changes. The risks associated with change can be severe, and if not managed properly, could…
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December 3, 2022
Organizational Risk Management
Organizational Risk Management Organizational Risk Management Organisational risk Management is an important component of a successful business strategy. It involves assessing and minimising the risks associated with activities in order to reduce the likelihood of losses or damage. It takes into account both internal and external factors, such as legal, financial, operational, and environmental risks…
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December 3, 2022
What is the Pharmaceutical Quality System?
What is the Pharmaceutical Quality System? What is the Pharmaceutical Quality System? The Pharmaceutical Quality System (PQS) is a set of guidelines that pharmaceutical companies must adhere to in order to ensure the quality and safety of their products. The PQS covers all aspects of the drug manufacturing process, from research and development to production and…
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November 19, 2022
Quality Auditing in Pharmaceutical Industry
Quality Auditing in Pharmaceutical Industry Quality Auditing in Pharmaceutical Industry Quality auditing is an integral part of the pharmaceutical industry. It ensures that products meet all government regulations and standards for safety and efficacy, as well as customer requirements. Quality auditing helps to ensure product quality by examining processes, materials, methods, systems, and services used at…
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September 12, 2022
Cleaning Validation In Pharmaceutical Industry
Cleaning Validation In Pharmaceutical Industry Cleaning Validation In Pharmaceutical Industry In the pharmaceutical industry, cleaning validation is the process of substantiating the cleaning strategy during manufacturing. Cleaning Validation is the system used to guarantee that a cleaning cycle eliminates buildups of the dynamic drug elements of the item made in a piece of hardware, the…
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September 12, 2022
Validation VS Calibration
Validation VS Calibration Validation VS Calibration The FDA first established the idea of validation in 1979 in an effort to raise product quality. Validation is documented evidence that provides the confidence that a process will consistently result in a product with the pre-specified requirements and quality. It is a process, procedure, or action that must be…
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August 7, 2022
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) Good Manufacturing Practice (GMP) is a set of guidelines introduced by the US Food and Drug Administration (FDA). It is a framework for guaranteeing that products are reliably created and controlled by quality principles. It is intended to limit the dangers implied in any pharmaceutical production that can’t be dispensed with…
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July 28, 2022
Pharmaceutical Validation
Pharmaceutical Validation The idea of Validation in pharmaceutical industries was introduced by the FDA due to the issues of parenteral items when it comes to sterility. It is perhaps one of the most significant and most used terms in the industry, and its straightforward importance is to provide assurance when it comes to product quality…
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July 18, 2022
Disintegration and Dissolution
Disintegration and Dissolution Disintegration and Dissolution Disintegration and dissolution are the two most commonly involved terms in the pharmaceutical industry. However, a large portion of individuals don’t have a clue about the specific contrast between these two terms. Disintegration is the vitro test that is performed utilising a basket rack assembly to check the rate…
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July 17, 2022
Thickness Test For Tablets
Thickness Test For Tablets Thickness Test For Tablets The test utilised to quantify how thick the tablet is is known as the tablet thickness test. To guarantee that the thickness of each tablet is within the predefined range as referenced in BMR, a thickness test for tablets is initially conducted after line clearance. Afterwards, it…
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