Supplier Quality Assurance Requires Hands-On, Risk-Based Strategy
This article was originally published in The Silver Sheet
CONTROLLING THE QUALITY OF SUPPLIED PARTS AND MATERIALS can be a daunting task for device manufacturers, particularly when dealing with numerous contractors and components. Industry consultants recommend a risk-based approach to managing supplier relationships, with the most intensive evaluation and monitoring reserved for suppliers of critical parts. FDA investigators indicate that many firms are not devoting adequate attention and resources to purchasing control and incoming product acceptance activities; their observations are borne out by a steady stream of supplier-related citations in warning letters over the past couple years
You may also be interested in...
US FDA investigators are more likely to cite cell and gene therapy manufacturers for facilities and production deficiencies, agency says, while industry reports difficulties complying with drug GMP requirements that are not always applicable to cell and gene therapies.
GSK’s antibody-drug conjugate may reach the market first, but CAR-T therapies from Bristol/bluebird and Janssen/Legend are close behind, and all three big pharmas have programs in earlier-stage disease.
Manufacturers warned to keep better electronic records and not falsify data in recent warning letters, ICH adds three residual solvent limits for pharmaceuticals, and the Polish authority hits firm for GMP noncompliance.