Internal Auditing – The Belt and Suspenders Approach to Quality in API Manufacturing

Six Considerations to Best Conduct An Internal Audit

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 hits. 

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 operations.


But what’s the best way to go about an internal audit? Consider the following:

  1. 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.
  2. 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. 
  3. 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.
  4. 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
  1. 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.
  2. 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.