When procuring pharmaceutical intermediates and active pharmaceutical ingredients, how can you ensure the reliability of the supplier’s product quality?

Ensuring the reliable product quality of pharmaceutical intermediates and active pharmaceutical ingredients is far from as simple as “just looking at a COA”; it is a systematic undertaking. The purchaser shall integrate the five key processes—qualification review, COA verification, on-site audits, batch‑to‑batch stability assessment, and supply chain assurance—into a cohesive, closed‑loop management system. Choosing a partner with comprehensive qualifications, proven quality, and a stable supply

2026-06-23 13:15:00 Procurement of pharmaceutical intermediates Supply Chain Management

What are the typical steps involved in collaborating with a CDMO to develop an API?

Collaborating with CDMO partners to develop APIs entails five key phases: project evaluation and approval, small-scale R&D, pilot-scale scale-up, trial production and process validation, and commercial manufacturing. This article systematically reviews the key tasks and critical considerations at each stage, helping pharmaceutical companies efficiently advance their API development projects and select the appropriate CDMO partner.

2026-06-23 12:16:00 API development process CDMO Collaboration

What compliance tasks must be performed when a supplier changes?

Supplier changes are categorized into minor, moderate, and major types. In accordance with applicable laws and regulations, such changes require the conduct of verification studies, including impurity profile comparisons, dissolution curve comparisons, and stability studies, and must be reported through either the annual report, filing, or supplemental application pathway. This article systematically reviews the key compliance requirements throughout the entire supplier change process, helping p

2026-06-23 12:15:15 Supplier change