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Medical device
Sumatha Kondabolu

Software Validation for Software as a Medical Device (SaMD): Ensuring Safety and Efficacy

Software Validation for Software as a Medical Device (SaMD) is a critical process that ensures the safety, efficacy, and regulatory compliance of software intended for medical purposes. Unlike traditional medical devices, SaMD operates independently of physical hardware, making its validation process unique and complex. This article delves into the key steps, regulatory requirements, and best practices involved in validating SaMD, providing valuable insights for developers, manufacturers, and regulatory bodies.

Sumatha Kondabolu June 28, 2024
Artificial Intelligence
Mona Ahmed Sayed

Integration of Artificial Intelligence in Pharmaceutical Manufacturing

Integration of Al in pharmaceutical manufacturing
Using artificial intelligence (AI) and machine learning (ML) are the most innovative technologies that are increased over the past few years in Pharmaceutical industry.
the integration of AI technologies holds great promise for accelerating drug development, improving patient outcomes, and revolutionizing the pharmaceutical industry

Mona Ahmed Sayed June 24, 2024
Manufacturing
Beatriz Rodriguez

Microbiology: The Manufacturing Zoo

The analysis identified 103 different genera, including bacteria, molds, and yeast, with the top two frequently isolated microorganisms being Pseudomonas spp and Bacillus spp. Pseudomonas spp, gram-negative rods, are common in water sources and manufacturing settings, posing contamination risks in various industries. Bacillus spp, gram-positive rods with endospores, are prevalent in finished products and raw materials, playing a vital role in industrial biotechnology. Understanding these microorganisms is crucial for effective quality control and prevention of microbial contamination.

Beatriz Rodriguez June 6, 2024
Quality
Beatriz Rodriguez

Quality Management: Heroic Versus Strategic Approach

Working at quality could be stressful, frequently fighting compliance issues or critical deviations
affecting production. Heroes rewarded for flowing to the work enabling restart of operations after an
unpredicted failure or unexpected warning letter from regulatory board. How can organization
culture move from heroic to strategic?

Beatriz Rodriguez May 23, 2024
Quality
Nathan Roman

Temperature Matters: Quality and Compliance in GMP Warehouses

In the detailed world of Good Manufacturing Practices (GMP), getting the temperature “just right” is more than a goal—it’s a critical necessity. For facility managers and maintenance teams, a slight deviation in temperature can mean the difference between product success and failure. “Temperature Matters: Quality and Compliance in GMP Warehouses” is not just a catchphrase; it underscores our commitment to maintaining the highest standards of quality and regulatory compliance. Let’s delve into the art and science of temperature mapping, a vital process that ensures every part of a GMP warehouse operates within the exact parameters required for optimal product safety and compliance.

Nathan Roman May 2, 2024
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Quality
Qualistery

Preserving Quality and Compliance: Which Storage Guidelines Should Be on Your Radar?

A significant proportion of medicinal products, including vaccines and biologics, are temperature-sensitive, requiring stringent storage conditions. The cold chain is crucial in the pharmaceutical supply chain, ensuring careful management of temperature-sensitive products. Auditors play a vital role in scrutinizing cold chain management, ensuring adherence to regulatory standards. European regulations such as EU GMP and EU GDP guidelines, along with the WHO Model Guidance, provide comprehensive frameworks for manufacturing, storage, and distribution, safeguarding the quality and safety of pharmaceutical products. Compliance with these regulations is essential for protecting public health.

Qualistery January 5, 2024
(COPY) Webinars - Wordpress
GMP Trivia
Qualistery

Deciphering Temperature Directives: The Guidelines Governing Pharma Storage

The pharmaceutical industry relies on precise temperature storage to maintain product effectiveness and safety. Regulatory guidelines provide general principles, while organizations like the ICH and USP define specific temperature ranges. Adhering to these guidelines is crucial for minimizing risks and ensuring product integrity. Strict temperature storage protocols are essential for delivering safe and effective medications to patients.

Qualistery December 26, 2023

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