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International Regulatory Framework IRF

International Regulatory Framework (IRF): Navigating Global Standards

What is International Regulatory Framework (IRF)? The IRF or International Recognition Framework is a new initiative that aims to streamline the regulatory approval process for…

Internal Auditing: Significance and the Regulatory Expectations

Internal auditing is a crucial component of the pharmaceutical industry that is responsible for ensuring compliance with regulations, maintaining product quality, and managing risks associated…
GxP Regulatory Best Practices

Implementing GxP Regulatory Best Practices

In the heavily regulated industries like pharmaceuticals, biotechnology, medical devices, and food production, adherence to Good Practice (GxP) regulations is of utmost importance. These regulations…

HVAC Systems: Requirements and significance in the life sciences industry

The HVAC (Heating, Ventilation, and Air Conditioning) systems in the life sciences industry play a critical role in maintaining the necessary environmental conditions for various…

HANDING OF OUT OF TREND RESULTS

In the pharmaceutical industry, “out of trend” typically refers to a situation where data or test results deviate from established trends or specifications, which can…

GxP Regulatory Inspections: What You Need to Know?

GxP regulatory inspections are a critical aspect of the pharmaceutical industry, ensuring that companies adhere to the guidelines and regulations set forth by the respective…

GxP Infrastructure Qualification: Ensuring Compliance and Efficiency

In the field of pharmaceuticals and medical devices, maintaining strict quality standards is of utmost importance to ensure product safety and efficacy. GxP, which stands…
GxP Compliance Software

GxP Compliance Software: Ensuring Quality & Regulatory in Life Sciences

In the fast-paced world of life sciences, maintaining the highest level of quality and regulatory compliance is crucial. GxP, which stands for Good x (practice)…
Good laboratory practice (glp) in pharma

Good Laboratory Practice in Pharmaceutical | An Introduction

What is GLP in pharmaceutical? Good Laboratory Practices (GLP) are a set of quality standards for the conduct of non-clinical safety studies. These studies are…

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