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Why Validation is Key to Safe and Effective Pharmaceutical Site Layouts

Validating pharmaceutical site layouts is crucial to ensure compliance with regulatory requirements, adherence to industry standards, and creating a user-friendly and efficient environment. Here are…
cGMP vs GMP: What's the Difference?

What’s The Difference Between cGMP and GMP?

It’s important for companies to follow the GMP guidelines when manufacturing new products. These guidelines ensure that everything is done cleanly and that every utensil…

Validation vs Qualification in Pharmaceutical Industry

In the highly regulated fields of pharmaceuticals, biotechnology, and medical devices, ensuring product quality, safety, and efficacy is of utmost importance. Two key processes that…

USFDA Inspections: What You Need to Know as a New Business Owner

The U.S. Food and Drug Administration (FDA) conducts various types of inspections to ensure compliance with regulations governing food, drugs, medical devices, cosmetics, and other…

Understanding the Details of Process Simulation for Regulatory Compliance

Process simulation, also referred to as media fill, is an essential component of pharmaceutical manufacturing that assesses a facility’s aseptic processing capability. Regulatory bodies such…
EU GMP Certificate Pharma Compliance & Benefits

Understanding EU GMP Certification: Pharma Compliance & Benefits

Pharmaceutical manufacturers, nowadays,consider EU GMP as a big step forward for their business. To integrate with the world and bring high-quality medicines to Canadians, Canada…

Ultimate Guide to 21 CFR Part 11 Regulations: Everything You Need to Know

In the world of modern technology and digital data, compliance with regulations is of paramount importance, especially in industries like pharmaceuticals, biotechnology, and medical devices…

Things to consider while setting up your Quality Management System

Quality Management System (QMS) is an essential requirement at all drug development and commercialization stages. At different stages, i.e., non-clinical, earlier clinical, to later clinical…

The Significance of Quality Assurance

Quality assurance (QA) in pharma is the process of ensuring that pharmaceutical products meet or exceed quality standards. This includes ensuring that the products are…

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