21 CFR Part 1271

Definition

21 CFR Part 1271 is a section of the Code of Federal Regulations that governs the regulation of human cellular and tissue-based products, ensuring their safety and effectiveness. This regulation plays a critical role in the oversight of cell and gene therapies, guiding how these products are developed, manufactured, and distributed. It establishes requirements for the registration of establishments, the use of good manufacturing practices, and the reporting of adverse events to protect public health.

5 Must Know Facts For Your Next Test

1. 21 CFR Part 1271 was established to address the growing need for regulatory oversight of cellular and tissue-based products as they became more prevalent in regenerative medicine.
2. This regulation requires establishments that manufacture human cellular and tissue-based products to register with the FDA and comply with stringent safety standards.
3. Under 21 CFR Part 1271, there are specific guidelines regarding the labeling, packaging, and storage of cellular products to ensure traceability and safety.
4. Manufacturers must also implement a quality management system that includes Good Manufacturing Practices (GMP) to maintain product integrity throughout the production process.
5. Adverse event reporting under this regulation is mandatory, which means any negative outcomes associated with cellular therapies must be reported to safeguard patient health.

Review Questions

• How does 21 CFR Part 1271 impact the development and approval process for cell and gene therapies?
  • 21 CFR Part 1271 provides a structured framework that regulates the development and approval processes for cell and gene therapies. By mandating compliance with safety standards and quality management systems, this regulation ensures that these therapies are both safe and effective before reaching patients. Additionally, it requires manufacturers to document their processes and report any adverse events, which enhances oversight and fosters trust in these emerging treatments.
• Discuss the importance of Good Manufacturing Practices (GMP) in relation to 21 CFR Part 1271 and how they contribute to the safety of cellular products.
  • Good Manufacturing Practices (GMP) are integral to 21 CFR Part 1271 as they set the quality benchmarks necessary for producing safe cellular products. These practices ensure that manufacturers consistently follow stringent procedures throughout the production cycle, from sourcing raw materials to final product release. Compliance with GMP helps mitigate risks of contamination, variability, or errors in product formulation, thereby protecting patient health and maintaining the integrity of the therapies being developed.
• Evaluate how international regulatory landscapes interact with 21 CFR Part 1271 in harmonizing standards for cell and gene therapies globally.
  • The interaction between international regulatory landscapes and 21 CFR Part 1271 is crucial for harmonizing standards for cell and gene therapies across different countries. As global markets expand for these innovative treatments, aligning regulations helps facilitate trade while ensuring safety. Organizations like the International Conference on Harmonisation (ICH) work towards creating guidelines that mirror those in 21 CFR Part 1271, promoting consistent quality assurance practices worldwide. This alignment not only simplifies compliance for manufacturers operating internationally but also enhances patient safety by standardizing product evaluation criteria globally.

Related terms

Cellular Therapy: A treatment that uses living cells to heal or manage diseases, often involving the transplantation of stem cells or other cell types.

Tissue Engineering: The science of combining scaffolds, cells, and biologically active molecules to create functional tissues for medical applications.

Adverse Event Reporting: The process of notifying regulatory authorities about negative reactions or complications arising from the use of medical products.