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The Indian pharmaceutical industry is of the view that the recent US FDA norms on container closure system will enhance quality and reliability of drug’s shelf-life.
The manufacturers emphasize that dedicated rules on the recent US FDA norms for container closure systems are a positive step toward enhancing the quality and reliability of drug shelf-life. These regulations are designed to ensure that containers effectively protect the drug from contamination and degradation over time, thereby reassuring both consumers and regulators of the product's safety and efficacy throughout its intended shelf life.
By adhering to these stricter guidelines, Indian pharma companies aim to bolster their credibility in the international market and demonstrate their commitment to high standards of quality control. This can be especially important for maintaining trust and meeting the expectations of global regulatory bodies and consumers alike.
The industry has been encountering and container closure system challenges. These include glass vials and stoppers among others. Especially pharma exporters dealing with sterile injectables, small volume parenterals, they need for caution on pathogenic bacteria, fungi or viruses pose the most obvious danger to a patient, in the absence of improper container closure systems.
US FDA in its guidance titled ‘Container Closure System and Component Changes: Glass Vials and Stoppers’ conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) regarding the reporting and implementation of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products, including biological products, administered parenterally.
Further, the guidance also discusses pathways available to application holders to obtain the global regulatory authority feedback. There are also discussions on risk-based tools available to facilitate the implementation of changes to container closure system consisting of glass vials and stoppers. However, the guidance does not apply to container closure system types other than glass vials and stoppers.
The reporting category for such changes depends on the potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as these factors may relate to the safety or effectiveness of the product. Therefore, changes can range from those that require approval before implementation with a notification 30 days before changes are being effected upon implementation, aid the global regulatory authority.
The guidance said that some of these identified changes to glass vials and stoppers for finished drug and biological products includes content derived from the referenced documents. It applies a risk-based approach to the evaluation of changes in components, composition, container type, suppliers, and manufacturers).
The enforced guidance mandates that applicants must validate the effects of the change prior to distribution of the drug, conduct additional qualification tests or submit information to address product specific risks as part of that assessment.
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