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Normas ASTM – AENOR
ASTM D8220-20

ASTM D8220-20

Standard Guide for Conducting Recall/Removal Procedures for Products in the Cannabis Industry

Fecha:
2020-06-09 /Active
Significance and Use:

4.1 In this guide, steps are suggested for the effective development, control, and management of procedures and records required for an effective product recall/removal from the marketplace.

4.2 This guide presents a systematic approach to procedures and documentation regarding the steps necessary to be taken in the event of a product recall or removal from the marketplace because of health, safety, or quality nonconformances.

4.3 This guide provides a procedural basis for conducting a mock recall for purposes of evaluating the efficacy of an organization’s existing traceability systems.

Scope:

1.1 This guide describes the general best-practices action plan for conducting product recall and removal/withdrawal as related to any incident requiring the recovery of cannabis-derived products. This guide applies to all cannabis-derived products commercially manufactured and distributed for consumer use. This guide is for suppliers, consumers, retailers, and distributors. A specific product recall decision is the result of unacceptable product safety and requires notification of the appropriate governmental agencies governing the entity’s product safety laws. Governing regulatory agencies expect a product to be recalled if it is deemed to be unsafe, misbranded, or adulterated. These governing agencies are referenced as regulatory agencies throughout this guide. Various jurisdictional regulatory agencies may have specific and additional recall requirements falling beyond the recommendations of this guide. In these cases, the requirements of the governing regulatory agency must be followed. This document also provides general guidelines for the removal/withdrawal of products from the marketplace. Product removal/withdrawal is undertaken for purely commercial reasons that are typically unrelated to product safety and does not require regulatory agency notification. Product removal/withdrawal is carried out in the same manner as a product recall. This guide is being published as a best-practices approach and does not replace absolute jurisdictional regulatory requirements.

1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Keywords:
cannabis; CAPA; CBD; hemp; product recall/removal; product safety; recall/removal procedures; QMS;
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