Quality Assurance and Quality Control Packaging of Materials-A Review
AbstractMaterial packaging is a crucial component of the pharmaceutical industry. The drug product's quality, stability, and identity are impacted by its packaging. Packaging should reduce component loss, offer an acceptable level of protection, and avoid physically or chemically interacting with what is inside in a way that could change their quality beyond the parameters specified in each unique monograph or pose a toxicity risk. In order to promote adherence to a prescribed course of treatment, pharmaceutical packaging offers protection, presentation, identity, information and convenience. Rubber, plastic, glass, metal, and cork are possible materials for the closing. Rubber, plastic, glass, metal, and cork are possible materials for the closing. To assess the quality, integrity, and compatibility of packing materials, a number of tests are available. Quality testing specifications and requirements vary depending on the kind of pharmaceutical products being used. Numerous techniques are used to test containers; notable tests for glass include the Cracked Glassware. Transparency testing is used to evaluate closure materials. Test for Penetrability Fragmentation Self-sealing proficiency exam, extractive exam, etc. Package material testing is required in accordance with regulations set forth by USFDA, WHO GMP, ICH, and other regulatory bodies.KeywordsDocumentation, Training Programs, Supplier Audits, Inspection Protocols, Visual Inspection, Shelf-Life Testing.
Institutions
- Hindu College of Pharmacy (IN)
Publication Details
- Journal
- Zenodo (CERN European Organization for Nuclear Research)
- Published
- 2024-10-01
- DOI
- https://doi.org/10.5281/zenodo.14886635
- Primary Topic
- Pharmaceutical Quality and Counterfeiting
- Type
- article
- Field-Weighted Citation Impact
- 0.00