Strategies for Extending Shelf Life of a Drug Substance: Case Study Overview
Constraints in the supply of a drug substance has a direct impact on the business and product continuity. The drug product applicant requested for feasibility of extending the shelf life of the drug substance so that the available lots can be used for extended period for manufacturing the drug product batches. This was a typical case which required a deep knowledge of regulatory nuances, extensive coordination with industry as well as regulatory stakeholders, ensuring business continuity for the drug product owner until an alternate source of drug substance could be identified and onboarded.
Extending the shelf life has the following benefits:
- Financial benefits: minimized waste and associated costs
- Operational benefits: improved supply chain management and enhanced business continuity
- Patient and healthcare benefits: increased product availability and patient access
To help the pharmaceutical industry in managing such changes, the regulatory authorities have laid down clear guidance on how the applicants can meet the current regulatory expectations while ensuring product quality, efficacy, and safety. Keeping oneself abreast with the current regulatory expectations, complying with which incurs huge amounts of cost, hiring trained regulatory professionals can help the industry deal with reducing the cost yet making their life easier especially when the product portfolio to be managed is quite vast and across different markets.
Drug Substance Shelf Life Extension During Post-Approval Phase: Case Study Highlights
The business challenges faced by the applicant were:
- Limited resources with right kind of experience
- Inability to onboard a new drug substance source
- Limited stock of drug substance in the warehouses
The strategies around this post-approval change were provided which included :
- Evaluation of the stability data available for the drug substance for extended period of time
- Assessment of impact of the newly generated quality data on the existing approved application
- Applying thorough understanding of the regulatory expectations for change categorization
- Identification of gaps and suggesting way forwards for successful compilation of the change package
APCER’s Regulatory Affairs Team was able to successfully author and submit the change package to the regulatory authority within stipulated timelines to ensure regulatory compliance and client satisfaction.
How can APCER Address Regulatory Challenges during post-approval phase?
APCER’s experienced regulatory affairs team helps the applicants/ marketing authorization holders to achieve the required outcomes through :
- Extensive knowledge on current regulatory expectations on post-approval lifecycle management for different markets including US, EU, UK and Canada
- Constant communication modules with different stakeholders and ensuring alignment with the regulatory expectations
- In house capabilities to author, review, electronically publish and submit high quality change packages to different regulatory authorities on behalf of applicants/ MAHs
In house monitoring of changes happening to the current regulatory expectations and keeping the applicants/MAHs informed well in advance to ensure compliance.