Regulatory Compliance

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.


Q: I just attended a meeting where someone talked about the concept of real compliance. Can you explain what they were referring to?


A: This is a great question because I believe there is a difference between regulatory compliance and real compliance. Naturally, let’s start with what we mean by regulatory compliance.




The current good manufacturing practice (CGMP) regulations for drugs contain minimum requirements for the methods, facilities, and controls. Subsequently, cGMP is also critically important in the manufacturing, processing, labeling, and packaging of drug products.


Regulatory Compliance


In the United States, some of the laws are delineated in section 501(a)(2)(B) of the Food, Drug, and Cosmetic Act, which states:


“A drug shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packaging, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this [Act] as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess” .



regulatory compliance

US Title 21 Code of Federal Regulations (CFR) Part 211 establishes the regulations based on the law. For instance, the regulations contained in 21 CFR Part 211 do not tell you how to specifically meet these regulatory requirements.


FDA Inspection


Instead, the law tells you what is expected of your quality management system (QMS) in order to achieve compliance to the regulations. The goal of regulatory compliance is to both satisfy the regulations and achieve a satisfactory outcome during an FDA inspection.


Compliance Regulations


Real compliance is how a company interprets compliance regulations and regulatory expectations, and apply them to their specific operations. Real compliance is rooted in a commitment to quality at all levels of an organization.


A real compliance approach takes a high-level view of quality and allows the organization to put in controls that help prevent deviations from occurring. It also provides a better understanding of the impact of regulatory and compliance deviations when they occur during manufacturing.


Regulatory Risk


Organizations that adopt a quality-based philosophy (real compliance) minimize the regulatory risk when deviations of a serious nature occur. Real compliance is the practical application of a quality management system and how it is integrated into modern manufacturing.


Manufacturing Processes


The quality commitment of real compliance lies within manufacturing processes. The goal is to achieve a sustainable state of control based on certified regulatory compliance. This includes at the manufacturing facility based on scientific principles, best practices, and continuous improvement efforts. The best way to explain the difference between regulatory compliance and real compliance is to perform a thorough regulatory risk management exercise.


21 CFR Part 11


The regulations clearly require companies to have written procedures that are in the form of standard operating procedures (SOPs). The common language used in 21 CFR Part 211 to indicate SOPs are required can be exemplified by 21 CFR 211.22


“Responsibilities of quality control unit”, which states “(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed” (2).


This type of wording can be found is sections of 21 CFR 211 governing personnel qualifications, building and facilities, equipment, production and process control, labeling issuance, warehousing procedures, etc. The regulatory requirement is met by having SOPs, but real compliance is met having SOPs that reflect your operations during a regulatory audit.


Standard Operating Procedure (SOP)


For example, data compliance regulations change from insourcing and outsourcing. If you outsource product testing you would not need an SOP on how to investigate out of specification (OOS) results because you are not performing that activity. Instead, you might replace it with an SOP describing how you work with your contract test laboratory when they are investigating an OOS result associated with your product.


Complaint Management


Another example between regulatory compliance and real compliance is just having a complaint department vs. handling customer complaints correctly. Complaint handling involves employees who understand and trained to manage customer complaints.


Design for Manufacturing


Further, training should consider design for manufacturing and how employees are empowered to resolve each customer complaint. Another difference between regulatory compliance and real compliance is having an organization chart that separates the quality & operations team. As an illustration, have your organization chart demonstrate where quality has the responsibility and authority to operate independently.


Compliance Example


Here’s a more practical example of regulatory compliance vs. real compliance. US 21 CFR 211.25(a) requires:


“Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience or any combination thereof, to enable that person to perform the assigned functions”.


A regulatory compliance approach would be to offer every employee annual GMP training and document their attendance. A real compliance approach would be to provide effective training to the employees by assessing their comprehension of the material and offering follow-up training as necessary.


Compliance Investigation


Another practical example of regulatory compliance vs. real compliance is examining how a company approaches investigations. A strictly regulatory compliance approach to an investigation results in a firm not determining the true root cause of an issue. Equally important, compliance investigation processes focus on the quality of the investigation instead of completing the investigation in a specific time frame.


Root Cause


Real compliance organizations focus on determining the true root cause(s) and using that information across their manufacturing facility to drive continuous improvements and prevent recurrence of the deviation that prompted the investigation. Taking a regulatory compliance only approach to operations may be less expensive in the short term. 


Article details






BioPharm International
Volume 35, Number 10
Pages 54, 52


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, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.


Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and 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, RCA® Inc. will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:


  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • 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 expertise in the remediation of warning letters, consent decrees, 483’s or import bans


Regulatory Affairs


Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our 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 pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.


  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services


Compliance Assurance


The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the experience and resources necessary to guide you in quality compliance.


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


Quality Assurance


Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.


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




Regulatory Compliance Associates® Inc. has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute.


We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.


  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services


About RCA


Regulatory Compliance Associates® (RCA) provides regulatory compliance consulting to the following industries for resolution of compliance and regulatory 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 more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.




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.