Q: There is often confusion with the labeling of purchased materials after they have been “inspected, tested and/or verified” according to good manufacturing practice (GMP)
requirements. Once out of quarantine, are purchased materials labeled as accepted, approved or released? I’ve had auditors and inspectors tell me all three.
A: Either term (accepted, approved, or released) is appropriate and commonly used. It would appear that the auditors are voicing an opinion and shouldn’t be. Neither ISO 13485:2003: Medical devices — Quality management systems — Requirements for
regulatory purposes or FDA’s quality system regulation (QSR) specify what language is to be used.
ISO 13485:2003, clause 18.104.22.168 status identification, states:
“The organization shall identify the product status with respect to monitoring and measurement requirements. The identification of product status shall be maintained throughout production, storage, installation and servicing of the product to ensure that only product that has passed the required inspections and test … is dispatched, used or installed.”
FDA 21 CFR 820.86 acceptance status requires:
“Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria. The identification of acceptance status shall be maintained throughout manufacturing, packaging, labeling, installation, and serving of the product to ensure that only product which has passed the required acceptance activities is distributed, used, or installed.”
The requirement should be clear for purchased materials: identify so that only those materials that passed acceptance activities are allowed to be used. Neither the standard or regulation states how the material is to be identified. That is up to the manufacturer to define in its operating procedure(s).
My personal recommendation is to use the terms “accept/reject” at receiving and during in-process, then use the terms “release/hold” to mean the final product is or is not to be released for distribution. But any similar terms are fine as long as they are consistently used throughout the quality system and personnel understand the requirement that they can only use product that passed their acceptance activities.
Voting member to the U.S. TAG to ISO TC 176 Quality Management and Quality Assurance
Medical Device Quality Compliance (MDQC), LLC.
ASQ Senior Member
ASQ CQE, CQA, RABQSA Lead QMS Assessor
Browse the free, open access articles below, or find more in the ASQ Knowledge Center.
FDA Regulations and Auditing Practices for Software Suppliers at a Pharmaceutical Manufacturer, Software Quality Professional
A review of 17 quality audit reports performed between 1992 and 2003 by an international pharmaceutical company identifies three time frames of audit maturity based on government regulation enforcement patterns, supplier quality practices, and the customer’s changing expectations. Read more.
Statistics in Pharmaceutical Development and Manufacturing, Journal of Quality Technology
An overview is given of the use of statistical thinking and methods in the research and development and manufacturing functions in the pharmaceutical industry. Four case studies illustrate how these issues work in real life settings. Read more.
Explore the ASQ Knowledge Center for more case studies, articles, benchmarking reports, and more.
Browse ASQ magazines and journals here.