Auditing is a good thing when it comes to confirming that
the procedures, equipment and practices used to develop life-critical Active
Pharmaceutical Ingredients (APIs) and other chemicals or medical devices won’t
compromise the safety of the people consuming them. This is a key reason why
the FDA and drug sponsors conduct regular audits of Contract Development &
Manufacturing Organizations (CDMOs). They provide peace of mind and documented
assurance that quality is paramount when producing powerful chemicals.
Although being audited is a common occurrence for CDMOs, no
CDMO likes to be surprised with quality concerns. By conducting their own
internal audits, however, they don’t need to be. Self-checking gives them the
assurance that they’re abiding by their own Standard Operating Procedures
(SOPs) as developed according to current Good Manufacturing Practices (cGMP),
and that they won’t be surprised with a Form 483 when a federal inspection
But aside from GMP adherence and
the fear of penalties, internal auditing is simply a good business practice. When a company
does its own routine evaluation of how well a specific system is designed and
operating – in an independent and
objective manner – it can identify strengths and weaknesses and find ways to improve
But what’s the best way to go about an internal audit?
Consider the following:
- Timing is everything. As with many things, the sooner problems are uncovered the faster they can be resolved. Any problem that is identified during an internal audit can be most easily addressed when it hasn’t had a long time to cause damage. On average, two-to-three internal audits is a good rule of thumb, although another consideration is that you don’t want too many internal audits, or else you’re impacting productivity.
- Revisit Your SOPs. While Standard Operating Procedures (SOPs) help to make sure that tried and true processes are in place throughout development and manufacturing, they should be revisited from time to time to remain current with changing situations, new regulations and cGMP. It’s also important to make sure they are not only effective, but that they are being adhered to across the organization.
- Appoint an internal auditor. There should be one person whose central role is to manage internal audits and that typically is the Quality Control (QC) manager. He/she should set the direction and take the lead managing an internal team of auditors. He/she also is responsible for reporting back to senior management during internal weekly meetings.
- Follow the FDA quality control approach. A convenient way to ensure you are covering all the bases is to use a proven approach that involves evaluation of six key operations:
- Quality Systems
- Production System
- Facilities and Equipment System
- Laboratory Controls System
- Materials System
- Packaging and Labeling System
- Create an internal audit plan. A good internal audit requires an audit plan, as well as timely audit reporting that communicates the audit’s findings to the organization. This report should include an assessment of compliance risk and a comparison to current industry standards, regulations and guidelines to ensure compliance.
- Put findings into action. There’s no question that internal auditing takes time and resources to complete correctly. For this reason, don’t conduct one in vain. Any issues that are uncovered should be addressed immediately with preventative and corrective actions. Whether this means conducting new training sessions, changing SOPs or upgrading equipment, the effort is well worth it.
Internal audits can provide a good check-up of your
SOPs, critical systems and best practices and provide an additional layer of
checks and balances that can go a long way to nipping problems in the bud. By
starting out with a solid audit plan, appointing key people to the task and
quickly acting upon issues identified, CDMOs can ensure they pass with flying
colors when audited by the FDA or sponsors.
This article is the second in a series on mastering audits in API manufacturing. Stay tuned for one on how a CDMO can prepare for a sponsor’s audit. To read the first article in the series, please visit: Paving the Way for a Smooth FDA Inspections.
About the Author
Ed is President & CEO of SEQENS North America (formerly PCI Synthesis). He serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA)...
Do you have questions? Talk to Ed.