20.08.2024 by Aileen Sammler
The Importance of CFR Compliance in the Pharmaceutical Industry
In the pharmaceutical industry, compliance with regulatory standards is of utmost importance to ensure safety, efficacy and quality of drugs and medical devices. One very important regulatory framework is the United States Code of Federal Regulations (CFR) issued by the Food and Drug Administration (FDA).
In this article, we explain the importance of the CFR in the pharmaceutical industry and show how NETZSCH analysis instruments meet these regulations.
What is CFR?
The USA is the world’s largest market for pharmaceutical products, both in terms of sales and innovation in the pharmaceutical industry.
The Code of Federal Regulations (CFR) comprises the regulatory provisions issued by the federal authorities in the USA. It is divided into 50 titles. Title 21 is reserved for FDA regulations and deals with food, drugs and medical devices. Within this title, several parts are directly relevant to the pharmaceutical industry, including:
- Part 11 (21 CFR Part 11): Electronic Records; Electronic Signatures
- Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
- Part 210: Current Good Manufacturing Practices for the Manufacture, Processing, Packaging or Storage of Drugs
- Part 211: Current good manufacturing practice for finished medicinal products
Why is CFR important in the pharmaceutical sector?
- Ensuring product quality and safety: Compliance with the CFR ensures that pharmaceutical products meet high quality and safety standards. This is critical to protecting patient health and public confidence in these products.
- Regulatory compliance: Compliance with the CFR is mandatory for pharmaceutical companies operating in the US market.
- Data integrity: "21 CFR Part 11" establishes the criteria for the use of electronic records and electronic signatures in the pharmaceutical, biotechnology and other regulated industries. The goal is to ensure that all electronic data and signatures are as reliable and trustworthy as paper-based documentation and handwritten signatures.
- Market access: Compliance with the FDA-regulations is a prerequisite for entering and remaining in the US market. Non-compliance can have serious consequences, including product recalls, legal penalties and loss of marketing authorization.
Side note: In Germany and Europe, specific national and European regulations and guidelines apply instead of the CFR (Code of Federal Regulations) to regulate the pharmaceutical industry. These regulations are closely aligned to ensure the safety, efficacy, and quality of drugs.
Importance of CFR Compliance for Analytical Instruments
Analytical instruments used in the pharmaceutical field play a critical role in both the preclinical phase and during production by precisely characterizing the properties of APIs, excipients and formulations.
Learn why compliance with the technical requirements of the CFR is often essential for these instruments:
- Accuracy and reliability: CFR-compliant instruments provide authentic, reliable and trustworthy electronic data and electronic signatures that can serve as the basis for drug development and quality assurance decisions.
- Data traceability: Compliance with the regulations set out in Part 11 ensures that electronic records are traceable, auditable and tamper-proof. This is crucial in the context of FDA audits, for example.
- Standardization: CFR compliance standardizes the way data is recorded, stored and retrieved, promoting consistency and reliability across departments and organizations.
- Audit readiness: Instruments that are CFR-compliant are designed to meet stringent documentation and reporting requirements, making it easier to prepare for and pass regulatory audits.
NETZSCH Thermal Analysis Instruments and CFR Compliance
NETZSCH Analyzing & Testing is a leading supplier of high-end analyzers for the determination of thermal and rheological properties of materials. The instruments are used in various industries, including the pharmaceutical industry.
NETZSCH DSC, TGA, STA instruments as well as NETZSCH rotational rheometers of the Kinexus series fulfill the requirements of 21 CFR Part 11. The DSC method stands for Differential Scanning Calorimetry, TGA for Thermogravimetry and STA for Simultaneous Thermal Analysis.
Rotational rheometers are used to determine rheological properties such as viscosity.
NETZSCH analysis instruments allow for secure electronic records and electronic signatures. This ensures the data integrity and traceability essential for regulatory compliance:
- Robust data management: NETZSCH thermal analyzers and rheometers are equipped with state-of-the-art software (Proteus® software for the DSC, TGA and STA; rSpace software for the Kinexus rheometers) that supports comprehensive data management, including audit trails, user management and secure data storage.
- User-friendly interface: The instruments are equipped with an intuitive user interface that makes it easier to use the instruments and thus comply with regulatory requirements.
Proteus® Protect, the CFR version of the Proteus® measurement and analysis software, is available for the DSC 300 Caliris®, the TG 309 Libra® and the new STA 509 Jupiter®, for example.
The new 21CFR11 option for the NETZSCH Kinexus rheometers series, available in the integrated rSpace software version 2.2, rounds off the range.
Conclusion
In the highly regulated pharmaceutical industry, compliance with CFR regulations is not only a regulatory requirement for companies, but also a fundamental aspect of ensuring the safety, efficacy and quality of manufactured products. Analytical instruments, such as those from NETZSCH Analyzing & Testing, play a critical role in this process, helping to ensure data integrity, regulatory compliance, and ultimately bringing safe and effective products to market.
Learn more on our website or get in touch with your regional sales contact!
