Articles for GxP Regulated Environments

Two crucial regulatory guidelines that describe the proper use of computerized systems to perform GMP-related activities are the Food and Drug Administration’s Title 21 CFR Part 11 and the EU GMP “Annex 11: Computerised Systems” published by the European Commission as part of EudraLex. This white paper analyses the requirements of Part 11 and Annex 11 as they apply to environmental monitoring nd validation, and outlines how Vaisala’s Continuous Monitoring System software viewLinc helps firms meet the requirements of both.

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In this white paper we outline a ten-step guideline for applying the GAMP methodology to the validation of environmental monitoring software. The goal of this article is to simplify the GAMP approach and highlight the particular steps that will  integrate your validation methods into your existing quality management systems. We  show how the effort level required in validation processes is heavily weighted upon system complexity (i.e. according to the GAMP System Categories). We present a GAMP-based approach to validation as with the goal of increasing the lifespan, usability, and compliance of continuous monitoring system software in GxP environments. 

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This eBook contains 10 articles on reducing the risks of failed inspections, poor quality management systems, and bad measurement practices.

Chapters include:

• Measurement Accuracy: The Good, The Bad and The Ugly
• The Tracks of Traceability: A calibrated $2 thermometer is still a $2 thermometer
• Capacitive Humidity Sensors: Advantages and Disadvantages
• Ensuring Accurate Humidity Measurement in Cleanrooms
• Instrument Tolerances: Manufacturer vs. Process
• Understanding the Performance of Test and Measurement Equipment
• To Wire or Not to Wire – Which Option Should you Consider for Sensing Equipment?
• Tips for Responding to FDA Form 483 Inspectional Observation s
• Tips on Preparing for an FDA Inspection: Are you following current good manufacturing practices?
• How to Map a chamber

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In this application note, we describe how mean kinetic temperature (MKT) has been identified as a tool for evaluating the impact of temperature on product quality. The MKT calculation can be a difficult to understand and apply properly. First proposed to guide stability studies, MKT is now considered as a tool for evaluating temperature excursions in the dynamic arena of Good Distribution Practices. We use the definition from ICH Q1A (R2), give an overview of the calculation history, outline the calculation, then provide guidance on where and when to use it in regulated environments.
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Stability testing and monitoring is a critical step in drug research, development and manufacturing. It impacts how pharmaceuticals are produced, packaged, labeled and sold. Creating the exact environmental conditions in a stability test is a complex process, but necessary to comply with standards defined by regulatory bodies like ICH and the FDA, as well as to ensure the safety and efficacy of pharmaceutical products.  In this application note, we look at the importance of sensor accuracy, and the most common causes of data gaps, as well as how to avoid those.

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In this white paper we outline a nine-point process for successful mapping of a warehouse or other regulated storage space:

1. Create a validation plan
2. Identify areas at risk
3. Develop protocol information
4. Determine sensor distribution
5. Select suitable technology
6. Set up mapping equipment
7. Conduct test and review data
8. Make modifications
9. Document and schedule mapping tests

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In this eBook our expert metrologists share several lessons learned on maintaining sensor accuracy for GxP compliance. Chapters include:

• Calibration Risk Assessment: Quality Control, CAPA & Early Warnings
• Instrument Tolerances: Manufacturer Vs. Process
• Three Ways to Wreck an Otherwise Excellent Calibration
• HOW to Calibrate with Saturated Salts as a Reference
• Determining Measurement Uncertainty

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The PDA’s TR39 was created in 2005 and revised in 2007 to harmonize it with EU regulatory expectations with the objective of providing “…guidance to industry on the essential principles and practices of transporting temperature-sensitive medicinal products through the transportation environment.” It has become a widely used reference for best practices in qualifying cold chain processes. The report is rooted in the Center for Drug Evaluation & Research (CDER) “Guideline on General Principles of Process Validation ”and suggests that the principles of that guideline can be employed to qualify, as much as possible, multiple
points in a temperature-controlled supply chain.

This application note gives an introduction to the Parenteral Drug Association’s technical report 39. Then, after outlining TR39, our regulatory experts offer several best practices for writing a performance qualification protocol for environmental monitoring systems.

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In this eBook our regulatory experts look at several guidelines for cold chain. We focus on these regulations regarding Good Distribution Practice:

• USP 36 <1079> Good Storage and Distribution Practices for Drug Products
• Temperature Tool Kit: Proactive/Reactive Tools, Staying Current| Proactive Tools
• USP <1070> Frequently Asked Questions
• A Brief introduction to EU GDP: EMA <2013/C 343/01>
• Other Relevant EU Guideline Updates
• GDP <2013/C 343/01>: Frequently Asked Questions

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In this brochure we provide an overview of Vaisala's offerings in GxP support documentation for its monitoring system and data loggers.

Products include:

• Vaisala viewLinc IQOQ documentation
• GxP Documentation Package
• Monitoring system validation service

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