The effectiveness of the quality management system (QMS) is a critical aspect of the audit. The QMS must be designed to ensure that all processes, from design and development to manufacturing and distribution, are monitored, documented and verified for compliance with quality standards and regulations.
During the audit, it is important to evaluate the manufacturer’s personnel training and qualification procedures to verify their effectiveness in ensuring that employees are adequately qualified to carry out their assigned duties.
The audit should evaluate the manufacturer’s risk management practices to ensure that they are adequate to identify and control potential risks associated with the design, manufacture, and distribution of the product.
DUE-DILIGENCE FOR MERGERS AND ACQUISITIONS
With its core expertise in the area of quality, compliance and regulatory affairs, Metina is well equipped to provide technical consulting to financial institutions / pharmaceutical companies to facilitate decision making for investment/ divestment projects.
Our team comprising quality, regulatory and portfolio experts can assist in the following areas:
Evaluation & ranking of technical capabilities of site/ company for long term business viability
Unbiased technical opinion to support decision making in case of business insolvency
Business risk mitigation by gap remediation for US/EU covering GMP norms/Warning Letters/Import Alert/NC
Due diligence & Expert Opinion on robustness of product pipelines & approvals (ANDA/ANDs/MAA/CEP/DMFs)
Commercial assessment of product portfolio to determine business viability