Internal Audit

Q: I am in charge of the internal audit program at my company and am wondering if you have any suggestions on how I can make this activity more valuable for my company?


A:  Internal audits are part of management responsibilities (1–3) and can provide valuable information and offer many benefits to an organization. The information obtained during the audit can be used in many ways to help your organization grow and continually improve its operations. How you approach the internal audit function will help the organization understand the advantages of supporting an effective, well-run internal audit program.


Internal Audit Design


If designed and implemented appropriately, internal audits can provide valuable information that can be used to prevent issues before they become compliance concerns during a regulatory inspection.


Issues can be identified and corrected before the regulatory authorities or current/potential clients identify them. If these issues can’t be completely remediated before an external audit, a plan to correct them can be established and action taken to mitigate them.


Corrective Action


Having corrective actions in place before others identify the issue may lessen the impact of the observation and instill confidence that your quality system is under control and there is a process in place for continuous improvement. In addition, the internal audit can be used for training staff and communicating valuable information to the organization.


Internal Audit Strategy


The strategy behind an internal audit is not to pretend to be the regulatory authority and show up unannounced but rather to work in cooperation with your colleagues to identify and solve potential issues. An effective program establishes a partnership between the audit function and the departments being audited. The ideal tone for an internal audit should be a team-oriented activity that is instructive, informative, open, honest, and inclusive.


Audit Schedule


There are several factors that help contribute to establishing this tone. One way to set the proper tone is to publish the audit schedule in advance and make sure the functional areas are informed of the schedule. The audit itself should be forward thinking and unlimited in scope. The auditors should work with the functional area and talk with as many employees as possible to identify the issues of concern.


Internal Audit Process


Individuals who are responsible for performing the day-to-day activities often have the best insight as to what is working and what needs to be improved. Excluding them from participating in the audit process might result in overlooking a serious issue that could come up during a regulatory inspection. To be able to get the most valuable information about the potential compliance issues facing the organization, internal audits should not be judgmental or antagonistic, or have a ‘check the box’ mentality in execution. They should also avoid looking retrospectively in lieu of looking forward.


Certified Lead Auditor


The behavior of the auditors during the audit is also important to obtaining valuable information. Auditors should be direct and avoid asking questions designed to stump people. The auditors should take this opportunity to teach by explaining why they are asking particular questions and providing the regulatory citation for the inquiry.


Audit Procedures


One of the most important audit procedures must be followed by the mock inspector. It is important their behavior includes the ability to listen to the answers to the questions and refrain from judging. The auditor should adopt a proactive approach to the audit and look at items that are infrequently assessed. Above all else, the auditor needs to be friendly.


Internal Auditor


The exact same behavior defined for the auditor should also be the exact same behavior displayed by the auditees. Auditees should be direct and avoid deflecting or obfuscating answers. They also need to be instructive and take the time to explain why they do things the way they do them.


Audit Committees


Leadership needs to listen to the auditor’s concerns and not overreact to the question being asked. They should be proactive and point out things of concern and seek advice on how to remediate them. Both parties need to remember they are not the enemies, rather they are the partners.


Audit Control


Internal audits are a valuable tool for identifying issues before others identify them. The information obtained during the audit can be used to improve your processes, and the audit process itself can be another tool to help train employees.


If you consider the internal audit as a gap analysis for your processes and set a tone of partnership and cooperation, you will find that the audit program and the information obtained from it will become a valuable resource for the organization rather than an unwanted intrusion into operations.



internal audit


Article Details

Pharmaceutical Technology
Vol. 41, No. 4
Page: 74


About RCA’s Pharmaceutical Consulting Services 


Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.


Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 


Client Solutions


Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:


  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans


Regulatory Affairs


Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.


As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.


  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products


Compliance Assurance


The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.


  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity


Quality Assurance


Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.


  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics


Remediation Services 


Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.


Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.


  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan


About Regulatory Compliance Associates


pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:



We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.


As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.


  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021


About Sotera Health


The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.


Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.


Commitment to Quality


Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.


To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 


Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.