Articles for GxP Regulated Environments

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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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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Quality, Metrology, and cGMP/FDA Regulations

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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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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Qualifying Cold Chains, Writing Performance Qualifications and the PDA's Technical Report 39 (TR39)

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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Cold Chain Management: USP, EU GDPs and Storage & Shipping Practices for Drugs

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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