Launching an OTC drug involves more than just mixing ingredients and designing a label. It requires strict adherence to FDA regulations and Good Manufacturing Practices (GMP). In our recent webinar, Bill Neumann, VP of QA and Regulatory Affairs, outlined a logical, 10-step process to ensure a compliant and efficient launch.
Here is the roadmap to getting it right:
1. Compare Concept to OTC Monograph
Ensure your active ingredients and formulation align strictly with the FDA monograph for your category.
2. Finalize Formula & Packaging
Lock in your formula and primary packaging early. Remember, you must qualify your suppliers and validate their certificates of analysis.
3. Create Specifications
You must have written specifications for raw materials, the container system, and the finished product.
4. Validate Test Methods
All analytical methods used for release and stability testing must be validated, or verified if compendial, to ensure accuracy.
5. Establish Expiration Dating
Use accelerated stability testing to approximate a launch date, but always back it up with real-time (RT) stability testing.
6. Create Product Labeling
Your label must comply with both the OTC monograph and general CFR drug labeling requirements.
7. Process Validation
Prove that your manufacturing process is consistent. The FDA expects validation data, typically from three batches, before you distribute the first batch.
8. Drug Listing
Register your product electronically with the FDA before launch and update it twice a year.
9. Annual Product Review (APR)
You must review every batch manufactured over the last 12 months to track trends, complaints, and changes.
10. Ongoing Stability Commitment
The work isn’t done at launch. You must test the first three commercial batches and at least one batch annually thereafter.
Following these steps in order can help you achieve a launch in the shortest time at the lowest cost.