GMP compliance problems at plants producing injectable products not only contribute to drug shortages but can also cause the manufacturing facility with the problems to become devalued and difficult to sell should the firm decide to put the facility on the market, industry experts are cautioning.
Sole source suppliers run a greater risk of creating shortages in the market when compliance problems crop up. In addition, contract manufacturing organizations (CMOs) that find themselves subject to compliance actions are particularly vulnerable to experiencing a loss in market value of the non-compliant plants.
The interrelationships between compliance problems, sole-source manufacturing, drug shortages and plant/product portfolio market value in the injectable arena were explored at the ISPE Tampa meeting in late February by PharmaBioSource CEO William Wiederseim.
PharmaBioSource is a leading pharmaceutical and biotechnology capacity, transaction and consulting service that has been involved with several of the significant plant sales over the past few years – providing Wiederseim with a unique vantage point on these interrelationships.
In the ISPE presentation, he pointed out the impact of non-compliance on drug shortages and manufacturing plant value in the context of discussing: ● parenteral product portfolios – “who is buying, who is selling” ● CMO activity ● parenteral plant construction activities – “where these facilities are being built and not being built” ● transaction benchmarks – when a site or a facility or a product is sold, what happens next, and ● challenges to the buyer and seller (Wiederseim’s complete remarks are included below).