Quality Risk Management in the Final Operational Stage of Sterile Pharmaceutical Manufacturing: A Case Study Highlighting the Management of Sustainable Related Risks in Product Sterilization, Inspection, Labeling, Packaging, and Storage Processes
Bassam Elmadhoun (),
Rawidh Alsaidalani and
Frank Burczynski
Additional contact information
Bassam Elmadhoun: Pharmaceutical Solution Industry Co., Ltd., Jeddah 21484, Saudi Arabia
Rawidh Alsaidalani: Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, 2409 University Ave, Austin, TX 78712, USA
Frank Burczynski: College of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB R3T 2N2, Canada
Sustainability, 2025, vol. 17, issue 4, 1-18
Abstract:
Quality risk management, commonly known as QRM, is designed to systematically assess, control, communicate, and review potential risks at every stage of the pharmaceutical manufacturing process. The preservation of consistent product quality across the entirety of the product’s life cycle is of paramount importance. The aim of this article is to formulate a best practice guide that will assist pharmaceutical manufacturers in comprehending and implementing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9: quality risk management principles. A widely recognized methodology for defining and monitoring risk mitigation strategies within the pharmaceutical sector is the Failure Mode and Effects Analysis (FMEA). ICH Q9 does not, however, offer detailed instructions for applying FMEA to real-world pharmaceutical situations. We previously provided real-world case studies that identify and mitigate risks in the early stages of the manufacturing process of sterile products, such as (1) supply chain and procurement; (2) logistics and warehousing; (3) raw material dispensing; (4) glass bottle washing and handling; (5) product filling; and (6) final product receiving and handling. The final steps of the sterile manufacturing process are the subject of the case study we present in this paper. We identify and control the risks related to (I) product sterilization; (II) product inspection, labeling, and packaging; (III) the finished product’s transfer to storage; and (IV) storing finished products in a warehouse. In order to maximize decision-making and reduce the risk of regulatory noncompliance, this case study describes a proactive strategy for the identification, management, and communication of risks associated with crucial tasks. While each organization’s products and methods are distinct, with varying tolerances for risk, certain stages and associated risks are common. Consequently, the examples provided here offer relevant insights into any pharmaceutical production environment. Managing sustainability-related risks and ensuring the transparency of pharmaceutical company operations are key tasks of success today. These risks, if not managed, will cause serious problems and a negative reputation, as well as environmental and public impact.
Keywords: quality management system; sustainability-related risks; GMP; FMEA; sterilization process; labeling process; packaging process; finished product storage process (search for similar items in EconPapers)
JEL-codes: O13 Q Q0 Q2 Q3 Q5 Q56 (search for similar items in EconPapers)
Date: 2025
References: View references in EconPapers View complete reference list from CitEc
Citations:
Downloads: (external link)
https://www.mdpi.com/2071-1050/17/4/1670/pdf (application/pdf)
https://www.mdpi.com/2071-1050/17/4/1670/ (text/html)
Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.
Export reference: BibTeX
RIS (EndNote, ProCite, RefMan)
HTML/Text
Persistent link: https://EconPapers.repec.org/RePEc:gam:jsusta:v:17:y:2025:i:4:p:1670-:d:1593229
Access Statistics for this article
Sustainability is currently edited by Ms. Alexandra Wu
More articles in Sustainability from MDPI
Bibliographic data for series maintained by MDPI Indexing Manager ().