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Tag: FDA

Drug pricing reforms in the United States are no longer speculative—they are real, enforceable, and imminent.
Quality Management System

The Changing Landscape of Drug Pricing: What Pharma Needs to Know in 2025

The landscape of drug pricing in the United States is currently undergoing a period of significant and unprecedented change, marked by potentially transformative reforms. This blog post delves into the intricacies of several key initiatives that are reshaping the pharmaceutical industry. Specifically, we will examine the Inflation Reduction Act, a landmark piece of legislation with far-reaching implications for drug costs.

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May 12, 2025
The isolator effectively separates the production area from personnel and the surrounding environment from contamination
Aseptic Manufacturing

Major Regulatory Guidelines on Isolators & RABS

Isolators and RABS both play critical roles in modern aseptic manufacturing, but their regulatory expectations differ significantly. FDA, EU, and ISO guidelines emphasize risk-based design, validated control measures, and procedural discipline.

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April 17, 2025
Establishing a robust pharma internal audit program ensures that processes remain efficient, risks are mitigated, and standards such as Good Manufacturing Practices (GMP) are maintained.
Audit and Inspection

The Start of Internal Audit in Pharmaceutical Companies

Explore and uncover the key aspects of efficient pharmaceutical internal audit processes, while also delving into the valuable ISO 19011 guidelines. Understand the importance of thorough audit program preparation, as it is essential for achieving success in your auditing efforts within the pharmaceutical industry.

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March 3, 2025
Blog

Getting Started with Process Validation

Learn the fundamental steps and best practices for successful Process Validation in manufacturing, covering design, qualification, and continuous monitoring to ensure product quality and compliance.

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September 9, 2024
GMP

How Environmental Monitoring Enhances Product Quality

In the pharmaceutical industry, ensuring product quality is paramount. Rigorous environmental monitoring plays a critical role in maintaining this quality by preventing contamination and achieving regulatory compliance. This blog explores how environmental monitoring improves pharmaceutical product quality, with practical insights.

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May 20, 2024
Quality Management System

FDA 21 CFR Part 211 and Understanding its Requirements

21 CFR 211 compliance is your organization’s stepping stone to meeting the FDA’s definition of current good manufacturing practice (cGMP). Complying with 21 CFR 211 proves that your business has a safe, effective, consistent and quality-managed drug manufacturing operation in place.

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May 6, 2024
Computerized System Validation

Computer System Validation: Key Strategies for Compliance

Computer Systems Validation (CSV) – is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable.

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March 4, 2024
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