In 1962, Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP) which should be compliant to FDA 21 CFR Part 210-211. The move was in response to concerns about substandard drug manufacturing practices at the time, such as the use of thalidomide, a drug used in Europe to treat morning sickness, which was found to cause birth defects. The 1962 Drug Amendments brought modern quality assurance and control principles to drug manufacturing. The word "current" was later added to make it "CGMP" (or cGMP) to imply that the regulation allows for changing technology in attaining GMP.
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FDA 21 CFR Part 210-211 contains the minimum CGMP for methods to be used in - and the facilities or controls to be used for - the manufacture, processing, packing, or holding of drug products to ensure that they meet regulatory requirements as to safety and strength, quality, and purity. Here's how the MasterControl™ quality management suite addresses 21 CFR Part 210 and 21 CFR Part 211 requirements:
|21 CFR Part 210 and Part 211 Requirements||MasterControl FDA 21 CFR Part 210-211 Features|
Sub Part B, Section 211.22, c & d
The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of drug product. The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed and compliant to FDA 21 CFR Part 210-211.
|MasterControl Documents™ automates routing, escalation, approval, and delivery of SOPs, policies, and other documentation. Provides a centralized Web-based repository that's secure, but at the same time accessible to all authorized users. MasterControl provides automatic revision control to ensure that only the current version of an SOP is available and compliance with FDA 21 CFR Part 210-211. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports.|
Sub Part B, Section 21 CFR Part 211.25, a
Each person engaged in the manufacturing, processing, and packing of a drug product shall have education, training, and experience to enable that person to perform assigned functions. Training shall be in the particular operations that the employee performs and in CGMP as they relate to the employee's functions. Training in CGMP shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
|MasterControl Training™ automates assignment and monitoring of training tasks and grading of online exams. Allows sequencing of training courses, so after a prerequisite is completed, the next course is automatically launched. MasterControl software provides group sign-off feature for verifying training of large groups of employees to ensure good FDA 21 CFR Part 210-211 training.|
Sub Part F, Section 21 CFR Part 211.100 a & b
There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, compliance with FDA 21 CFR Part 210-211 regulations and purity they purport to possess. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. Written production and process control procedures shall be followed in the execution-and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.
|MasterControl Change Control™ streamlines the entire change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change is likely to require regulatory filing. Customizable reports provide real-time status of change control tasks, ensurity of FDA 21 CFR Part 210-211 compliance and the entire quality system.|
Sub Part J, Section 21 CFR Part 211.198a
Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed. Such procedures shall include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience, which is required to be reported to the FDA.
|MasterControl Customer Complaints™ streamlines the FDA 21 CFR Part 210-211 complaint handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with processing of a complaint, moving to internal investigation, and culminating with issue resolution. Includes the FDA's MedWatch 3500A form for mandatory reporting of adverse events, allowing a seamless handover to an adverse events specialist while ensuring that required data is immediately collected.|
Sub Part J, Section 21 CFR Part 211.192
All drug product production and control records-shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy-or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. A written record of the FDA 21 CFR Part 210-211 compliance investigation shall be made and shall include the conclusions and follow-up.
|MasterControl CAPA™ integrates the corrective and preventive action process with other quality processes which ensures FDA 21 CFR Part 210-211 compliance. Provides best-practice "8D" process that guides the quality team through every step of CAPA. A CAPA form can be launched directly from another form (i.e., a nonconformance report). Automatically enters relevant data into a CAPA form, reducing data entry and eliminating errors from manual transfer of information. Provides customizable reporting capabilities to help managers monitor entire quality management life cycle.|
Sub Part J, Section 21 CFR Part 211.180e
Written records shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the FDA 21 CFR Part 210-211 compliant constraints and need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations.
|One of the best ways to evaluate the quality standards of a drug product is through quality audits. MasterControl Audit™ automates, streamlines, and effectively manages the audit process. Provides advanced tracking capability, from scheduling and planning to execution and completion. Offers best practice forms for tracking basic audit information and audit findings. Automates scheduling of all recurring audit-related activities and provides analytics and reporting capability for Increased Management Visability.|
21 CFR Part 211.84
Requires the testing of components for conformity with all appropriate written specifications for purity, strength, and quality.
|MasterControl Nonconformance™ is designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. The FDA 21 CFR Part 210-211 compliance is the best-practice which involves five-step process to connect all responsible personnel for effective and timely disposition of a nonconformance.|
The term "corrective and preventive action" (CAPA) is not explicitly stated in FDA 21 CFR Part 210-211. However, the Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations includes CAPA as a concept of modern quality systems. In discussing nonconformities, the guidance also directs the reader to refer to 21 CFR Part 211.192.
MasterControl is compliant, helping you meet FDA 21 CFR Part 210-211 and other FDA regulations year after year, while keeping compliance costs down.
MasterControl is connected, giving you the ability to monitor the entire quality system and continuously improve it.
MasterControl is complete, meeting every department's needs to ensure FDA 21 CFR Part 210-211 compliance and that quality initiatives are enforced across the enterprise.
Contact a MasterControl representative to learn more about FDA 21 CFR Part 210-211 compliance regulations and how the MasterControl quality management solution can help streamline both compliance documentation and quality management tasks.