Articles for GxP regulated environments

Using GAMP methodology to validate environmental monitoring system software

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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Mean kinetic temperature: definitions, history & proper use

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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Matching environmental monitoring & mapping to FDA/ICH guidance for better stability studies

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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GMP warehouse mapping: guidelines for validating GxP storage facilities

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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How Vaisala's Continuous Monitoring System aids compliance with Title 21 CFR Part 11 and EU GMP Annex 11

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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