Whitepaper: Remediation requires transparency: A process for managing quality and compliance
Standardization and alignment of the drug development and manufacturing process allow high-performing companies to globally source and efficiently produce pharmaceutical and biopharmaceutical products.
Recent well-publicized quality control errors within the industry have shown that it is impossible to negate all risks involved in the design, development and manufacturing of pharmaceutical or biopharmaceutical products. However, the bulk of them can be addressed through a clear remediation plan with routine regulatory inspections intended to reveal any deficiencies related to either part, or all, of the pharmaceutical manufacturing process, so that they may be isolated and addressed. It is important for a manufacturer to also support this plan with transparency in the supply chain.