Pre-approval readiness for a new pharmaceutical product involves ensuring a facility can manufacture a drug product meeting quality, safety, and efficacy standards, including a pre-approval inspection (PAI) by the FDA.
Introducing a new pharmaceutical product requires strategic planning, regulatory compliance, and rigorous validation to ensure a smooth transition from development to commercial manufacturing.
Key Aspects of Pre-Approval Readiness:
Our Services Include:
- Technical and regulatory feasibility assessment to ensure global compliance.
- Technology transfer from development to full-scale production.
- GMP documentation management and regulatory compliance for audits and approvals.
- Process validation and optimization to enhance efficiency and quality.
With our team of experts, we minimize risks, optimize timelines, and facilitate the seamless integration of new products into pharmaceutical manufacturing facilities.
- FDA Pre-Approval Inspection (PAI): The FDA conducts a PAI to evaluate product, process, and facility risks, ensuring the facility can manufacture the proposed drug and that submitted data are reliable and complete.
- Facility Readiness: The facility must be capable of manufacturing the drug product according to the methods used in manufacturing, processing, packing, and testing, which must be adequate to preserve the drug's identity, strength, quality, and purity.
- Data Reliability and Completeness: The FDA will assess the reliability and completeness of the data submitted in the application.
- Subject Matter Experts: If a PAI is initiated, the FDA assembles a team of subject matter experts in chemistry, microbiology, process/facility operations, and formulation to assess the company's readiness.
- Strategic Planning: Companies should engage in strategic planning to ensure their facility is prepared for a PAI.
