From annual inspections by the FDA to regular auditing from sponsoring companies, Contract Manufacturing Organizations (CMOs) are under close scrutiny to ensure that their procedures and quality control processes keep them in good standing with Current Good Manufacturing Practice regulations (cGMP), Federal Drug Administration (FDA) and International Standards Organization (ISO) guidelines.
But quality CMOs should never stop there. Implementing regular internal audits can help ensure that there are no issues that could impact the APIs and pharmaceuticals they produce, their safety and efficacy and the safety of the lab and its staff.
All CMOs have their own Standard Operating Procedures (SOPs) in place that on occasion need to be revisited to make sure they are not only effective, but that they are being adhered to across the organization. An internal audit gives CMOs the opportunity to identify their strengths and weaknesses and possible risks and find ways to improve their organizational effectiveness to benefit current sponsors and those to come.
In the most extreme case, conducting internal audits help improve the odds that the FDA won’t beat you to the punch, and can help ensure that any future FDA inspection doesn’t end with a notation on form 483, which could impact drug approval.
So to make sure the odds for successful product commercialization come to pass, and to comply with cGMP regulations, CMOs need to conduct regular and frequent internal audits – at least several times a year – which can reveal issues that need attention.
In many cases, many of the problems that are revealed during an internal audit can be easily addressed if there are short timespans between audits. Yet when problems are uncovered with huge gaps between audits, they can impact multiple batches of chemicals, going back many months and sometimes you don’t know about them until it’s too late.
For example, an internal audit could reveal that there may be something wrong with your cleaning protocol, which can make every batch that came out of the equipment suspect. If you catch it early on, perhaps it only impacts a few recent batches that need to be analyzed.
So how can a CMO go about implementing a sound internal auditing program? Below are four key considerations.
Internal audits provide a good snapshot of the health of a CMO’s critical systems. By following consistent processes that focus on proper planning, analysis and reporting they provide one more assurance of the safety and quality of essential operations, and help ensure FDA and other external audits result in no negative findings – all necessary steps to help you get one step closer to product commercialization.
Do you have questions? Talk to Ed.