Testing, Commissioning, Validation, Qualification, or Verification? A Brief History – Part 3

In Part 3 of my history of Testing, Commissioning, Validation, Qualification, and Verification, I’ll describe the intent and reality of ASTM E2500 along with some practical advice for implementing an ASTM E2500 risked based approach to qualification of Biopharmaceutical and Pharmaceutical manufacturing systems. The 2006 draft of Science and Risk-Based Approach to Qualification of Biopharmaceutical…

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Continued Process Verification (CPV): The often overlooked (but much needed) 3rd Stage of Process Validation

The FDA process validation guidance, Guidance for Industry: Process Validation- General Principles and Practices, outlines and separates process validation activities in three stages;  Stage 1: Process Design (where Critical Process Parameters or CPPs and Critical Quality Attributed or CQAs are determined), Stage 2: Process Qualification,  and Stage 3: Continued Process Verification (CPV).  The first two…

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FDA’s Case For Quality Head Explains The Agency’s 2020 Maturity Model Pilot For Medical Device Manufacturers

Executive Summary Cisco Vicenty tells how the US agency will structure its pilot program for device-makers with less-than-stellar FDA compliance histories that want to use the CMMI maturity model framework to improve the quality and maturity of their manufacturing organizations – and clean up their FDA compliance problems along the way. The FDA – which…

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Next Steps For Serialization In The Pharma Supply Chain

Over the last two decades, the global pharmaceutical industry has been working to secure the supply chain, through the development and implementation of serialization standards in over 50 markets. Although outliers remain, in general, pharmaceutical products in the impacted markets will have unique identifiers in an attempt to secure the legitimate supply chain from infiltration…

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FDA Compliance Management – Perfecting CAPA

“Flawless” may not exist on the plant floor, but reviewing your quality process can save money and lives Many years ago, while working on developing a Quality Management System for a large automotive company, we heard a story about how the company had perfected Corrective Action, Preventive Action (CAPA). The company had a clearly defined,…

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Improving the quality and accuracy of your data

Few industries are scrutinized by regulators as carefully as the pharmaceutical industry. Manufacturers of medicine should, for example, be able to demonstrate at any time how they meticulously follow the Standard Operating Procedures (SOPs), and how patient safety is never compromised. But how do you ensure you have the most current, accurate, and complete data…

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What is an Automation Engineer?

An Automation Engineer utilizes technology to improve, streamline and automate a manufacturing process.  They are responsible for planning, implementation, and monitoring of such technology. Let’s take a closer look at the details of automation and the role of an Automation Engineer. What is Industrial Automation Exactly? At its most basic level, automation consists of three…

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Network Analysis/Assessment

Automated Systems Inc. is partnering with Revere Electric Supply Co. to provide Network Analysis/Assessment services. These services provide various levels of testing, troubleshooting, and analysis for your network infrastructure from reactive network assistance through proactive assessment. These services not only can help find faults in your network, it can also assess your current network and…

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Are you on Track (and Trace) to meet your Serialization deadlines?

The Serialization team at ASI knows how important it is to prepare for the Drug Supply Chain Security Act (DSCSA). The purpose of the DSCSA was to create a comprehensive electronic system to “track” and “trace” the passage prescription drugs through the supply chain in the United States, as of Nov 24, 2017.  FDA link…

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Risk Management for Medical Devices

Risk management consist of the application of policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, mitigating and monitoring risks as described by ISO 14971, ISO 13485, FDA’s 21st century GMP and ICH initiatives (such as Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System).  Especially after the aforementioned guidelines…

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