Sensor Placement in Validation/Mapping: Where & How Many?
Hi, my name is Paul Daniel, I am the Senior Regulatory Compliance Expert at Vaisala with 16 years of validation experience in the pharmaceutical and medical device industries. Vaisala is a world leader in innovative solutions for measuring environmental parameters; we provide environmental monitoring, measurement and validation systems designed for life science applications.
In today’s global economy, drugs, biotechnology and medical devices are shipped all over the world. To ensure these temperature-sensitive products are stored correctly, new and revised regulations have been developed in many areas, including China, Europe, and the U.S. Universally, these new Good Distribution Practice (GDP) regulations recommend performing mapping studies to qualify storage areas. The two most common questions I hear regarding mapping studies are: 1) where to place sensors, and 2), how many sensors to use. My webinar will directly address these questions, discussing five rules to apply when creating a rationale for sensor placement in mapping studies.
Global regulators, including the Food and Drug Administration (FDA), the European Medicines Agency (EMA), China’s SFDA, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) require manufacturers to determine if environmental parameters affect product quality and perform stability testing to determine appropriate product storage specifications. It is the job of those in the “cool chain” to help ensure that those storage specifications are met. Unfortunately, most regulations offer little guidance on how to perform a mapping study. For example, the location and number of sensors that are needed to qualify a given space are not dictated by the regulations; it is left to manufacturers and distributors to determine adequate sensor placement as part of their quality processes.
In addition to recommending mapping studies, the new GDP regulations explicitly assign responsibility for following the GDP regulations to the entire distribution network. Practically, this means that a large number of previously unregulated entities must now secure their portion of the cool chain, and that will include performing mapping studies. This has created a demand for clear and concise guidance to support mapping studies, and at the forefront of this demand are the two questions raised previously: 1) where to place sensors, and 2), how many sensors to use. To meet this demand I developed the “5 Rules of Sensor Placement”. These rules are based on my years of practical experience, and I have verified them against recent guidance from the USP, PDA, and ISPE. It is my hope that these clear and concise rules can guide a new mapping practitioner to a reasoned rationale for sensor placement in mapping studies, and supply much needed guidance in this critical activity. Here they are:
Rule 1: Map the extremes.
Rule 2: Map in 3 dimensions.
Rule 3: For large spaces, map storage only.
Rule 4: Identify and address variables.
Rule 5: If it’s worth mapping, it’s worth monitoring.
You can use these rules as part of a plan to create an accurate profile of storage conditions through a consistent validation program. This will establish that the environment is adequately understood, documented and controlled; and it will also it demonstrate that it is safe for sensitive products and compliant with GDP. Moreover, the information obtained from reasoned, well-executed mapping studies will inform decisions on how controlled areas are monitored continuously, making monitoring choices evidence-based. Such an approach to monitoring temperature, humidity and other critical parameters ensures that any auditor or inspector will find a shining example of environmental control when they visit your facility.
I hope you will join me for this presentation that is designed to give those new to validation the fundamental methods of determining sensor placement in mapping studies. We at Vaisala are experienced in delivering webinars and love to hear feedback, here is an example from a previous webinar:
“Vaisala’s webinars are wonderful — especially for someone who is trying to learn as much as possible about this field, but comes from a very different background and is on a limited budget.” Danielle, Validation Technician
To view the Vaisala webinar live on April 8 2014, click here
I have attached a link to view some webinar highlights for ‘Video Validation for GxP Environments’: http://www.youtube.com/watch?v=ygCu3cA9BMk
An example of a relevant Case Study
McKesson Delivers Pharmaceuticals Safely & Reliably with Standardized Environmental Monitoring in 60 Distribution Centers http://www.vaisala.com/Vaisala%20Documents/Success%20Stories/CEN-LSC-AMER_McKesson_Success%20Story%20LOW.pdf
Exemplified below is a relevant whitepaper
How the Vaisala Continuous Monitoring System Aids Compliance with Title 21 CFR Part 11 and EU GMP Annex 11 http://www.vaisala.com/Vaisala%20Documents/White%20Papers/CEN-LSC-G-Vaisala-CMS-Part11-Annex11-WhitePaper-B211305EN-A.pdf
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