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Vaisala Customer Magazine - Regulations and Standards for Temperature-Controlled Supply Chains -30 Years of National Lightning Detection -How to Preserve 18,000 Years of Artwork -Creating Value for Customers

Text of Vaisala News 190/2013

  • Regulations and Standards for Temperature-Controlled Supply Chains / Page 4

    30 Years of National Lightning Detection / Page 8

    How to Preserve 18,000 Years of Artwork / Page 10

    NEWS

    VAISA

    LA

    190/2013

  • 190/2013

    Cover photo: Shutterstock / Editor-in-Chief: Sanna Nystrm

    Publisher: Vaisala Oyj, P.O. Box 26, FI-00421 Helsinki, FINLAND

    Phone (int.): + 358989491 / Telefax: + 358989492227

    Internet: www.vaisala.com / Layout: Sampo Korkeila

    Printed in Finland by: SP-Paino / ISSN 1238-2388

    Contents 3 Creating Value for Customers

    4 Regulations and Standards for Temperature-Controlled Supply Chains

    8 30 Years of National Lightning Detection

    10 How to Preserve 18,000 Years of Artwork

    12 Lightning Research Through the Years

    17 Alert! Roadway Prone to Flooding

    19 Tracks Across Europe

    20 Accredited or Certified?

    22 Briefly Noted

    Vaisala in Brief

    Vaisala is a global leader in environmental and industrial measurement. Building on 75 years of experience, Vaisala contributes to a better quality of life by providing a comprehensive range of innovative observation and measurement products and services for chosen weather-related and industrial markets. Headquartered in Finland, Vaisala employs approximately 1,400 professionals worldwide and is listed on the NASDAQ OMX Helsinki stock exchange.

    What regulations, standards and guidelines to take into account to make sure that the fundamental requirements of a safe supply chain for drugs and biotechnology are satis-fied? Page 4

    Vaisala is celebrating the 30-year anniver-sary of the U.S. National Lightning Detection Network. The first ever lightning strike was recorded on June 1, 1983. Page 8

    Vaisalas instruments monitor carbon dioxide in the prehistoric Lascaux cavern to preserve its 18,000 years of artwork. Page 10

    2190/2013

  • Presidents Column

    We at Vaisala have always valued opportunities to push ourselves and our offering and services to the next level for the benefit of our cus-tomers. This thinking is highlighted in our vision: we want to be the leading provider of operational value in the markets we operate in.

    This means that we strive to understand our customers business and use that understanding to drive our offering development so that we are able to offer products and services that are not only techno-logically advanced but also give our customers that little bit of extra to help them succeed in their mission. A part of it is that we provide a reli-able customer experience in every contact a customer has with us, and simplify our own operations so that the service we provide is quick and efficient, whatever the circumstances.

    Creation of customer value is only possible if we focus on what our customers want from us and what matters to them the most. One continuous effort to keep us on the right track is our annual Customer Satisfaction Survey. This years survey is currently being carried out I want to warmly thank everyone who has taken the time to respond. Every piece of feedback is truly appreciated.

    The Customer Satisfaction Survey gives us an objective overview on

    what is expected from us and how our performance is valued. Positive feedback is always appreciated as an indicator of satisfied customers after all, this is what we work hard for every day. But for me, the true value of the survey lies in the critical feedback, as it helps us pinpoint the areas where we need to improve our performance in order to serve our customers even better.

    The results will be in and the resulting actions shared during the coming fall. Im looking forward to seeing what kind of a difference the development efforts we have imple-mented since last year have made.

    Creating Value for Customers

    Kjell ForsnPresident and CEO

    190/20133

  • The two greatest risks in pharma-ceutical and biotechnology supply chains are the risk of product becom-ing adulterated during transport and the risk of non-compliance with federal regulations, guidelines and standards.

    Two organizations that carry significant regulatory weight are the combined forces of the US Food and Drug Administration (FDA) and the International Conference on Harmon-isation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Whereas the jurisdiction of the FDA is primarily in the United States and Puerto Rico, the ICH is an international entity that involves the US, Japan and the European Union.

    In this article we look at the FDA regulations and ICH guidelines that address supply chain management for temperature-controlled pharma-ceutical and biotechnical products, including: ICH Guidance for Industry Q1A(R2)

    Stability Testing of New Drug Sub-stances and Products

    ICH Harmonised Tripartite Guidelines Q6A and Q6B (Test Procedures and Acceptance

    Criteria for New Drugs and New Biotechnology)

    FDA CFR Title 21 203.32, 203.36, 211.150

    FDA 483 observations on cold chain applications with suggested deviation offsets

    Moving temperature-sensitive products renders the supply chain a cold chain (sometimes also called cool chain), and products that fall under the purview of federal law and enforcement agencies further evolve the logistics process into a regulated cold chain. However, there is cur-rently no single standard, guidance, regulator, document or arbiter with the final say on a compliant cold chain for a given region.3 Instead, manufacturers and distributors face a myriad of regulations, require-ments, conferences, technical reports, guidelines and recommenda-tions from disparate agents.

    Scientific Approach to Cold Chain Management

    To simplify your approach to cold chain management into a principle, ask yourself what any regulatory body (and inspector) will want to

    know. From a regulatory standpoint, the question always comes down to the quality and completeness of your scientific (i.e. verifiable) knowledge of a product and the environments it moves through before reaching the end user.

    A common introduction to many is an FDA Form 483 observa-tion: Your firm did not establish scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, product containers, in-process materials, and transport methods conform to appro-priate standards of identity, strength, quality and purity.

    As in all FDA-regulated appli-cations, establishing and docu-menting data on your operating environments that are scientifically sound should be your underlying

    Regulations and Standards for Temperature-Controlled Supply Chains

    Basing supply chain

    management firmly

    in the regulations,

    standards and

    guidelines of ICH and

    the FDA will ensure

    that the fundamental

    requirements of a safe

    supply chain for drugs

    and biotechnology are

    satisfied.

    4190/2013

  • goal in compliance efforts. Cold chain quality engineers, cold chain managers, packaging engineers and other stakeholder must understand their environmental conditions and product parameters better than any inspector. After the knowledge of conditions and parameters is estab-lished comes the documentation of that knowledge, without which, it may as well not exist.

    ICH Guidance

    The ICH publication: Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products4

    describes proper management of temperature excursions in shipping and short-term storage applications.

    For testing and acceptance crite-ria of closure systems for new drugs (chemical) and new biotechnology, refer to these guidances: Q5C Quality of Biotechnological

    Products: Stability Testing of Bio-technological/Biological Products5

    Q6A Specifications: Test Proce-dures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

    Q6B Specifications: Test Proce-dures and Acceptance Criteria for New Drug Substances and New

    Drug Products: Biotechnological/ Biological Products

    While not specific to distribu-tion applications, these guidances contain valuable criteria for creating tests that will ensure products are protected during shipping and short-term storage. A crucial element to creating a compliant cold chain is to create tests that accurately represent the real-time, real-world shipping environment, including primary and secondary containers, transport and storage durations, seasons and climatic zones.

    It should be remembered that the ICH guidelines arent standards; rather, they are guidance for meeting technical requirements and are intended to be used in combination with any regional requirements8. Quality managers, cold chain engineers, and anyone whose responsibilities include a temperature-controlled supply chain are accountable for understanding ICH recommendations. FDA inspec-tors often cite non-adherence to ICH9.

    In the Q5 guideline, under Storage Conditions Part 6.3, Acceler-ated and Stress Conditions10 the ICH recommends that stress tests be performed in order to define the conditions that may occur during transportation that will affect the

    product. To recommend testing, the guide is necessarily broad because of all the different types of products that might be shipped. The testing will not only determine the condi-tions that impact the product, but should also determine which tests are best for determining stability.

    Regulations by US Food & Drug Administration

    Three key regulations from the FDA that address cold chain are:1. 21 CFR 203.32 Prescription Drug

    Marketing Drug sample storage and handling requirements. This subpart (D--Samples)