黄人导航

Regulatory Compliance

Susan J. Schniepp, distinguished fellow at Regulatory Compliance 黄人导航, 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鈥檚 start with what we mean by regulatory compliance.

 

cGMP

 

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:

 

鈥淎 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鈥 .

 

regulatory compliance

US Title 21听Code of Federal Regulations听(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听CFR Part 211 to indicate SOPs are required can be exemplified by 21 CFR听211.22

 

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

 

This type of wording can be found is sections of 21听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鈥檚 a more practical example of regulatory compliance vs. real compliance. US 21听CFR 211.25(a) requires:

 

鈥淓ach 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鈥.

 

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.听

 

Article details

 

 

 

 

 


Volume 35, Number 10
Pages 54, 52

 

About RCA’s听Pharmaceutical Consulting Services

 

Regulatory Compliance 黄人导航 (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 黄人导航 offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

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About Regulatory Compliance 黄人导航

 

pharmaceutical consultantsRegulatory Compliance 黄人导航听(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 , , and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory听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鈥檚 unwavering commitment to its mission, Safeguarding Global Health.

 

Sotera Health Company, along with its three best-in-class businesses 鈥 ,听听and听, 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.

 

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