From researching, to development, to distribution, creating an effective drug within the pharmaceutical industry takes an incredible amount of time and money. Given the inherent complexity of a drug’s formula, along with increased competition and mounting pressure to drastically decrease time-to-market and costs, it’s imperative that if production issues arise, they’re addressed swiftly and effectively to avoid disaster.
With the added pressure to meet FDA standards to secure patents, ensuring a drug is safe for public consumption requires little variation in the efficacy of the drug, and without consistent effectiveness, drug manufacturers can face complaints, investigations, and even costly lawsuits.
To head off these complications before commercialization, corrective and preventative action (CAPA) plans are instrumental in reducing non-conformances and reaching the high FDA benchmarks drugs are subject to before and after going to market.
The industry views the CAPA process as critical to their success by providing the risk-assessment necessary for pharmaceutical manufacturers to mitigate any non-conformances when they arise.
When a non-conformance does arise, whether during production or in the field, having a sound CAPA process in place to review documentation, roles and responsibilities of stakeholders, and technology involved in production helps drug manufacturers find, fix, and validate the problem without the risk of losing billions of dollars.
By identifying and evaluating the validity of an issue, intaking all relevant information, such as documentation or filed complaints, and appraising the potential impact, manufacturers can not only fix the non-conformance but use the information to develop processes to ensure the non-conformance does not occur again.
To address non-conformances, CAPAs put measures in place to:
With such prescriptive processes and documentation, if a complaint is filed or the FDA investigates or conducts an audit, the manufacturer can prove that corrective and preventative actions have been taken to mitigate non-conformances.
PLM software provides the capabilities necessary to successfully identify and plan CAPAs. With PTC’s industry-leading PLM software, Windchill, enterprises can unify engineering, quality, and regulatory teams to ensure they are coordinated and involved in correcting and preventing product errors. With Windchill, you can meet CAPA standards and demonstrate compliance with extensive failure reporting best practices. You can learn more about CAPA and Windchill here.
Derek Koziol has over 20 years as an experienced Continuous Improvement leader with deep expertise in Six Sigma, lean, change management and program management.
With an MBA and LSSMBB, he has led global enterprise Product Lifecycle Management (PLM) initiatives in several industries ranging from technology and automotive, to complex pharma and medical devices.