Compliance 21 CFR Regulations

FDA 21 CFR Part 1271

21 CFR 1271 Regulations

What is 21 CFR 1271?

Human cells, tissues and cellular and tissue-based products (HCT/Ps) are critical in cardiac and reconstructive surgeries, wound closures and many other life-saving medical procedures. The U.S. Food and Drug Administration (FDA) protects the supply of HCT/Ps by enforcing the Current Good Tissue Practice (CGTP) requirements found in 21 CFR Part 1271. CGTP guidelines are aimed at ensuring the safety of HCT/Ps by preventing the introduction, transmission and spread of communicable diseases.

Compliance with FDA's Good Tissue Practices

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CGTP / Good Tissue Practices

The requirements for CGTP are found in subparts C and D of 21 CFR 1271 that govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps. This includes, but is not limited to, all the activities and tissue processing steps involved in the recovery, donor screening, donor testing, processing, storage, labeling, packaging and distribution of HCT/Ps as delineated in a guidance issued by the FDA in 2011. The 21 CFR 1271 good tissue practices for HCT/Ps function in tandem with the 21 CFR 1270 guidelines for the use of human tissues intended for transplantation.

21 CFR Parts 1270 and 1271 Regulations

Quality Management:

21 CFR Part 1271.160 Subpart D mandates that an organization that performs any step in the manufacture of HCT/Ps must establish and maintain an effective quality program. An electronic quality management system (QMS) can facilitate compliance with CGTP quality requirements by automating and integrating quality-related tasks, standardizing and streamlining operations and promoting efficiency.

Written Procedures:

21 CFR Part 1271 Subparts C and D and 21 CFR Part 1270.31 require that written procedures must be prepared and followed for all significant operational steps and that associated records must be maintained. A QMS solution simplifies compliance with these requirements by centralizing document databases and automating document routing, approvals, escalations and revision control.

Inspection Readiness:

21 CFR 1271.400 Subpart F and 21 CFR Part 1270.41 Subpart D state that the FDA may inspect HCT/P manufacturing locations at any time to determine compliance. Robust QMS solutions enable companies to maintain inspection readiness by storing documents and records in an accessible web-based repository where they can be easily located and retrieved during inspections or audits.

Software Validation:

21 CFR Part 1271.160 Subpart D states that software used during the fulfillment of any tissue processing steps must be compliant with core CGTP requirements. A CGTP-compliant software solution can ensure continuous validation and dramatically reduce the time, pain and costs involved in validation.

Major Differences in 21 CFR 1270 and 1271

In 1993, the FDA published an interim rule concerning human tissues intended for transplantation, requiring testing for certain communicable diseases and establishing criteria for donor screening and record keeping. When finalized in 1997, this rule evolved to become 21 CFR 1270, which necessitates certain infectious disease testing, donor screening and record keeping for the prevention of the transmission of diseases through human tissue used in transplantation.

Recognizing a need for a more comprehensive and wide-ranging system of compliance provisions for similar products, the FDA proposed a new approach to the regulation of HCT/Ps that same year. The FDA has since published three final rules to implement various aspects of its proposed approach to good tissue practices. The first of these final rules was published in 2001, creating 21 CFR Part 1271.

MasterControl Features

MasterControl’s integrated, easy-to-use software solutions facilitate CGTP compliance and help companies meet the requirements of 21 CFR Parts 1270 and 1271 by providing useful features such as:

  • Change control: MasterControl’s change control capabilities streamline the entire change management process and promote a more proactive approach to CGTP compliance. The system’s best-practice forms address change priority levels, classifications and risk assessments.
  • Training management: MasterControl automates the assignment and monitoring of employee training tasks and the grading of online exams. It includes training course sequencing capabilities and group sign-off functionality for verifying training of large groups of employees.
  • Complaints management: MasterControl streamlines customer complaint handling by ensuring data is collected expediently, escalated properly and stored appropriately. Built-in forms are predefined according to 21 CFR 1271 requirements to help accelerate complaint lifecycles.
  • Audit management: In addition to recording time-stamped audit trails of all documented activities, the MasterControl system automates the scheduling of all audit-related actions and leverages the advanced capabilities of best-practice audit forms and tracking tools.
  • Quality event management: MasterControl integrates corrective and preventive action (CAPA) activities with all other quality processes. The solution’s ability to launch a CAPA form directly from other forms eliminates data entry errors per 21 CFR Part 1271 guidelines.

MasterControl Solution

MasterControl enables blood banks, transfusion centers, tissue banks and other organizations concerned with good tissue practices to maintain and accelerate compliance with 21 CFR Parts 1270 and 1271. The cloud-based solutions offered by MasterControl provide a secure working environment and document repository for CGTP-related documents without requiring large up-front expenses or overburdening IT departments. MasterControl’s flexibility allows HCT/P organizations to improve their existing forms according to 21 CFR Part 1271 regulations or to design new and better forms to enhance their good tissue practices. Designed to help companies replace manual paper-based processes with more efficient electronic systems, MasterControl solutions empower CGTP-minded organizations to bring compliant and safe products to market with greater efficiency.

QMS Provider for the FDA

MasterControl Inc. and its partner company, i4DM, have been the QMS providers for the FDA’s Office of Regulatory Affairs (ORA) since 2009. The FDA recently expanded its implementation of MasterControl’s Quality Excellence™ solutions to improve the quality and audit management processes of the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).

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