34 Articles found
Particle Measuring Systems (PMS) Articles
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EU GMP Annex 1 FAQs - Air Speed Strategies for Unidirectional Flows
The following frequently asked questions arose at a presentation given by PMS Senior GMP Scientist, Mark Hallworth, on the 6th of December on the topic of EU GMP Annex 1 Air Speed Strategies for Unidirectional Flows. Why do manufacturers like ...
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A New Challenge for Quality Experts - the Data Quality Concept
Abstract The role of quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality ...
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EU GMP Annex 1 Commonly Asked Questions
Welcome to our EU GMP Annex 1 questions and answers blog, where Particle Measuring Systems answers commonly asked questions about the latest changes to regulation. Listen to this useful webinar to learn more about the latest ...
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Safe Vaccines
Part of Particle Measuring Systems’ role in making the world make the world cleaner, healthier & more productive As part of the Spectris PLC family of businesses, we aim to deliver value to society by providing solutions ...
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What is Syringe Sampling?
Welcome to the world of liquid particle counting and syringe sampling! If you’re new to liquid particle counting, you might not know anything about how we know if liquids are clean. One method to determine a liquid’s cleanliness is ...
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Catching Up with GMP Requirements
This two-part blog series discusses current good manufacturing practices (GMPs) and how they can be applied to a continuous environmental monitoring system installed within a pharmaceutical manufacturing facility. Quality and Production teams can ...
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How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Activity Organization (Series Part 6 of 6)
Over the previous five Blogs in this series we have discussed the critical quality attributes to consider in a robust Quality by Design plan for the construction of a new Isolator/RABS fill line. The primary topics we explored are: Regulatory, ...
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How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Set up and Process Interventions (Series Part 4 of 6)
Set up and Process Interventions on a fill line are two of the most difficult operations to overcome if they are not designed to properly minimize impact to the product and the environment in the early stages of Isolator/RABS design. Set up of the ...
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How to Achieve Quality by Design (Qbd) in a New Pharmaceutical Fill Line: Cleaning and Disinfection (Series Part 3 of 6)
The cleaning and disinfection of a pharmaceutical fill line & surrounding areas is a critical component of contamination control. We all think we are familiar with the principles of cleaning protocols, but it is deceptively easy to get this ...
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How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Surrounding Areas (Series Part 2 of 6)
The area surrounding an isolator/RABS pharmaceutical fill line can be a difficult area to control. There are many functions and moving parts that support the fill operations that occur in the controlled area just outside the controlled area that can ...
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How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line: Intro and Regulatory (Series Part 1 of 6)
What does Quality by Design (QbD) in the design of clean manufacturing equipment and processes look like? This might be easier to visualize if we look at it from the perspective of the absence of it. Design and optimization based on ...
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It is possible for pharmaceutical quality to be the combination of Quality by Design (QbD) and current Good Manufacturing Practices (cGMP)?
The following is the summary of a noteworthy discussion from the 2019 GMP Academy Master Course – Particle Measuring Systems, Rome, Italy The first GMP Academy Master Course took place from November 26 – 28 at Particle Measuring Systems ...
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Electronic Data in Pharmaceutical Manufacturing: Reducing Operator Error (Series Part 5 of 6)
Reducing Operator Error Reducing operator error is and always will be the goal of any system where human interaction takes place. This is seen on a regular basis in manufacturing. For example, it has been widely held for years that visual human ...
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Electronic Data in Pharmaceutical Manufacturing: Rapid Response to Deviation Events (Series Part 4 of 6)
Rapid Response to Deviation Events The creation of risk assessment documentation is a basic requirement for implementing a monitoring plan, and rapid response to deviation events is expected. ISO 14644 requires manufacturers to create and ...
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Electronic Data in Pharmaceutical Manufacturing: Secure Data Transfer (Series Part 3 of 6)
Secure Data Transfer Even small businesses with a single particle counter or other analyzer can benefit from the secure data transfer that a real-time online monitoring system provides. Real-time monitoring systems can, with great reliability, ...
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Electronic Data in Pharmaceutical Manufacturing: Benefits of Paperless Reporting (Series Part 2 of 6)
Benefits of Paperless Reporting in Pharmaceutical Manufacturing Paperless pharmaceutical manufacturing sites are a relatively new concept. In 2015, ISO updated their Standard 14644 to include data integrity issues that allowed ...
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Electronic Data in Pharmaceutical Manufacturing: Data Integrity (Series Part 1 of 6)
Data Integrity - Data Storage & Retrieval Data integrity means data that is accurate, complete and repeatable, which in turn ensures the product’s quality and public safety. Compliance is the goal of improving process control, product ...
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Maintaining Quality in Stem Cell Products: Quality Control Considerations (Series Part 3 of 4)
All starting materials should have minimal microbiological contamination. Your contamination control strategy should document the quality of the materials in terms of microbiological monitoring or other requirements. The bioburden assay should be ...
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Maintaining Quality in Stem Cell Products: Recent Developments in Regulation (Series Part 1 of 4)
Background Stem cells are naturally occurring cells in the body that have the ability to divide and produce a range of different cell types. They are important in the growth and development of the body as well as repair after injury. The past few ...
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Sterility Assurance Applied to Stem Cell Therapies
Abstract Stem cell therapies are becoming more important in the pharmaceutical industry. The genetic manipulations of the cells involved create a powerful tool to treat serious diseases, such as cancer. In 2017, the Food and Drug Administration ...