Equipment quality in pharmaceutical manufacturing is ensured through IQ, OQ, and PQ phases, validating installation, performance, and user needs. Regulatory mandates prevent hazards, like mislabeling, with ongoing compliance via requalification. Expert guidance streamlines validation efforts for robust, compliant systems.
GAMP is the acronym used to summarize the term “Good Automated Manufacturing Practices“. These are a compilation of recommendations published by the International Society for Pharmaceutical Engineering (ISPE) in the form of a book to provide guidance on the compliance of computerized systems in regulated industries.
In the pharmaceutical industry, GMP inspections ensure quality and compliance, demonstrating commitment to safety and building trust with healthcare professionals and patients. Understanding the inspection process, guidelines, and common deficiencies is crucial for upholding industry standards and ensuring patient safety.
Is continuous improvement essential for pharmaceutical companies? Dive into methodologies like Lean, Six Sigma, and Kaizen for measurable results
Is your pharma company still relying on periodic CSV checks? Uncover how AI can elevate your validation processes, reduce risks, and give you a competitive edge in the market.
Find out why you should consider Quality Management and how we can support you on this journey
The challenge of efficient Computer System Validation (CSV) is one that many organizations face. But what if you could master CSV without the usual headaches?
In an interview with Pharmatechnik magazine, Alireza Zarei discussed the challenges of digital compliance in the pharmaceutical industry
From research to reality: TerraTrust, the green pregnancy test.
In the field of Good Manufacturing Practices (GMP), a new generation of inspectors is urgently needed. Why?
The biggest challenge when founding Zamann Pharma was defining a vision that was big enough to define body and soul and recruiting people who shared this vision.
CSV Automation: Turning Weeks into Seconds, While Enhancing Compliance
Building Confidence and Qualifications for Pharmacy Students – Explore Pharmuni!
For the second year in a row, our Quality Management System was TÜV Süd-approved and qualified. This year, our certification extended from two to a total of four areas of application.
In the course of the last year a multitude of COVID tests have been developed or are in the process of being developed. But, it is the PCR test, for the detection of SARS-CoV-2, that has been the central talking point. The classic PCR test was developed in the 1980s and was a major milestone in laboratory diagnostics. It is
Let’s start by asking the question: What is quality? In simplified terms, quality is the sum and/or the quality of all properties of an object, system or process. The international standard for quality management systems DIN EN ISO 9000 goes a step further and describes quality as: “The capability of a totality of inherent characteristics of a product, a system
