Work Item
ASTM WK92020
New Guide for Raw Material electronic Goods Receipt and Release (eGRR) Data Transfer from Materials Suppliers to Pharmaceutical & Biopharmaceutical Manufactures
1. Scope
This guide is applicable to all elements of electronic data required for raw materials goods receipt and release from a Supplier which provides a raw material to a Customer which receives the raw material. This guide is developed for pharmaceutical and biopharmaceutical manufacturers and their suppliers, but may be suitable for other industries that routinely transfer data. The guide may also be applicable to raw material eGRR data transfer between companies in the supply chain. The guide is applicable to new and existing raw materials. This guide is applicable to the life-cycle of a raw material (that is, data required from receipt to inventory to production throughout the manufacturing stages of the raw material) and is not dependent on the Supplier or Customer. This guide describes two major areas of eGRR data standard: the data format and the data content including the taxonomy and nomenclature. The format is based on Extensible Markup Language (XML) 1.0.
Keywords
Goods Receipt and Release; Digital; Incoming Raw Materials; Logistics and Supply Chain
Rationale
Pharmaceutical & biopharmaceutical manufactures require various types of documents, certs, etc. in order to comply with regulatory, quality, and cGMP requirements for receiving and releasing incoming critical incoming raw materials and consumables used in production. Missing supplier product data upon receipts, causing delays in production schedules resulting in late shipments and reduced customer revenues. Digital and automated data from suppliers will optimize the receipt and approval process, improve operational efficiencies, and accelerate time-to-inventory to meet production schedule.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 08-19-2024
Technical Contact: Stephen Wing
Item: 000
Ballot:
Status: