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Follow UsAs pharmaceutical manufacturers face tighter margins and a host of regulatory and validation issues that are increasing the need to produce drugs at lower costs and at a faster pace, they are likely to turn to automation and software vendors to help them achieve operational efficiency in drug production.
With strict regulatory approvals, manufacturers are finding it increasingly difficult to introduce new drugs in the market. This has greatly influenced the number of drugs entering the market. Hence, there is an emerging need to implement lean and flexible concepts to reduce wastage and bring drugs faster to the market.
The gradual exit of blockbuster drugs and the introduction of generic ones have increased the pressure on profit margins, compelling manufacturers to produce specialized potent drugs that are difficult to replicate and need to be produced in smaller quantities, notes Frost & Sullivan Research Analyst Sanjeev R. Sridharan.
As this necessitates the production of multiple products on the same equipment, companies are increasingly employing automation and software solutions.
Process analytical technology (PAT) is encouraging pharmaceutical manufacturers to adopt innovative technologies without fearing validation risks and production delays, thereby fuelling demand for automation and software solutions. The revised 21 Code of Federal Regulations (CFR) Part 11 regulation stipulated by the Food and Drug Administration (FDA) requires pharmaceutical manufacturers to provide greater production transparency through audit trails and access control functions.
It also puts forth the criterion that electronic records and signatures are equivalent to paper records and handwritten documents in manufacturing processes. Therefore, companies are compelled to develop sophisticated means of electronic validation and batch recording.
However, as the pharmaceutical industry is highly regulated, the FDA audits and approves every new process addition. The risk of non-compliance is too high for pharmaceutical companies and thus, massive investments on automation and software solutions are relatively lesser.
The key success factor for automation companies is to establish long-term partnership with pharmaceutical customers,' says Sanjeev. Even as pharmaceutical customers look for standardization, automation companies need to grow aggressively with their customers as they expand globally.
CIOL Bureau