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https://www.um.edu.mt/library/oar/handle/123456789/139392| Title: | Risk management by the marketing authorisation holder in product quality review |
| Authors: | Gauci, Jeremy Azzopardi, Lilian M. Attard Pizzuto, Maresca |
| Keywords: | Drugs -- Quality control Pharmaceutical industry -- Quality control Pharmaceutical industry -- Risk management Pharmaceutical technology -- Standards Pharmacovigilance |
| Issue Date: | 2025 |
| Publisher: | International Pharmaceutical Federation, Federation Internationale Pharmaceutique |
| Citation: | Gauci, J., Azzopardi, L. M., & Attard Pizzuto, M. (2025). Risk management by the marketing authorisation holder in product quality review. Pharmacy Education, 25(4), 13-14. |
| Abstract: | Introduction: Product
Quality Reviews, forming part of the current Good Manufacturing Practices, are periodic product quality assessments
of all authorised pharmaceutical products, including those intended for export only Product Quality Reviews are performed
to ensure that the current specifications for raw materials and final products are appropriate and reliable, to identify any
trends that the current manufacturing procedure is consistent and to determine ways to enhance both the product and the
process The Marketing Authorisation Holder is responsible for conducting routine product reviews and audits of the
manufacturing processes in addition to adhering to Good Manufacturing Practice. Aim: To carry out a risk assessment, using Failure Mode and Effect Analysis, on the Product Quality Reviews performed by the Marketing Authorisation Holder to identify the risk imposed, if any, if the current checks are not executed |
| URI: | https://www.um.edu.mt/library/oar/handle/123456789/139392 |
| Appears in Collections: | Scholarly Works - FacM&SPha |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| Risk management by the marketing authorisation holder in product quality review 2025[poster].pdf | 193.25 kB | Adobe PDF | View/Open | |
| Risk_management_by_the_marketing_authorisation_holder_in_product_quality_review(2025).pdf | 670.52 kB | Adobe PDF | View/Open |
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