21 CFR Parts 210 and 211

Learn About FDA's Quality Systems Approach, Pharmaceutical GMP Inspection Tips, and How to Automate Paper-based Quality Processes to Ensure Compliance with FDA 21 CFR Part 210-211

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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Pharmaceutical CGMP for 21st Century

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Q&A: Pharmaceutical CGMP for 21st Century Q&A: FDA's Quality Systems Approach to Pharmaceutical CGMPs
White Paper: Ensuring the Adequacy of the Informed Consent Process in GCP Regulated Environments White Paper: FDA Guidance for Clinical Investigators, Sponsors and IRBs Regarding Adverse Event Reporting in GCP Regulated Environments White Paper: How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market White Paper: Change Control - Continuous Quality Improvements in FDA and ISO Environments White Paper: How Software Helps Pharma/Biotech Maximize Value of External Resources
Product Data Sheet: MasterControl™ Solutions Overview Product Data Sheet: MasterControl Documents™

Differences Between 21 CFR Parts 210 and 211

While 21 CFR Parts 210 and 211 both apply to GMP of drug products, each part addresses a different set of guidelines.

Part 210 – Outlines the minimum GMP requirements covering manufacturing, facilities, and controls for the manufacture, processing, packing, and holding of all drugs in a way that meets the guidelines for safety, quality, and purity.
Part 211 – Outlines the minimum GMP requirements for finished drug products. Part 211 also covers various other areas, including personnel, facilities and equipment, production processes, stability testing, and labeling.

21 CFR Parts 210 and 211 Requirements

Document Control:

Subpart F, Section 211.100 – There shall be written procedures for production and process control, assuring that drug products have the intended identity, strength, quality, and purity. Written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units.

Change Control:

Subpart I, Section 211.160 – Any changes in specifications, procedures, sampling plans, or other laboratory control mechanisms shall be documented at the time of performance and reviewed by the appropriate organizational units.

Training:

Subpart B, Section 211.25 – Each person engaged in the manufacture, processing, packing, and holding of a drug product shall have the necessary education, training, and experience to perform the assigned functions.

Customer Complaints:

Subpart J, Section 211.198 – Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and reviewed by the quality control unit.

Corrective and Preventive Action (CAPA):

Subpart J, Section 211.192 – Any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated. A written record of the investigation shall be made and shall include the conclusions and follow-up actions.

Audits

Subpart J, Section 211.180 – All records, or copies of records, shall be readily available for authorized inspection. Records shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting this requirement.

Nonconformance:

Subpart E, Section 211.84 – Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. Any lot of components that does not meet the specifications shall be rejected.

Staying Compliant and Connected

Compliance with the 21 CFR guidelines for pharma requires efficient management of disparate GMP functions to ensure drug products meet the requirements for safety, quality, strength, and purity. Automating quality and manufacturing management is the most effective way for pharmaceutical companies to collaboratively manage all aspects of drug product development.

MasterControl’s Quality Excellence™ solutions integrate all quality and manufacturing processes, making it easier to achieve compliance with all 21 CFR 210 and 211 requirements, including documentation, changes, training, complaints, CAPA, audits, and nonconformance.

MasterControl Solutions Specific to 21 CFR Guidelines

Achieving compliance with 21 CFR Parts 210 and 211 requires strict attention to all of the GMP requirements. MasterControl equips you with all of the necessary tools to successfully meet the regulatory guidelines:

MasterControl Documents™ – Automates routing, version updates, approvals, and distribution. It stores all documents in a secure, central repository for easy search and retrieval.
MasterControl Change Control™ – Automates every step of the change control process, from submission through implementation, verification, and end of lifecycle.
MasterControl Training™ – Streamlines and increases the efficiency of training management tasks, from routing and tracking to follow-up and escalation.
MasterControl Customer Complaints™ – Provides a secure and centralized platform for receiving customer complaints, organizing data, and storing documents for easy correction of issues.
MasterControl CAPA™ – Streamlines all CAPA tasks, including data gathering, routing, escalation, and approval for more efficient and accurate CAPA management.
MasterControl Audit™ – Improves efficiency of audit planning and preparation, capturing findings, and creating customizable audit reports.
MasterControl Nonconformance™ – Automates the processes for identifying, evaluating, reviewing, and handling nonconforming materials, components, parts, and finished products.

How to Achieve 21 CFR Compliance With MasterControl

More companies are discovering that achieving compliance with 21 CFR Parts 210 and 211 is easier using automated technology. MasterControl’s Quality Excellence™ solutions have functionality that directly aligns with all of the GMP guidelines. Other benefits of using MasterControl include:

Unified platform – A fully connected and collaborative organization is essential for regulated companies. MasterControl integrates all quality and manufacturing management applications, processes, data, analytics, reports, and document control tasks on one centralized platform.
Risk management – MasterControl Risk™ unifies all risk-related activities for a more complete and accurate picture of the risk landscape across business units, processes, and products.
Accelerates compliance – Increases operational efficiency, improves product quality, and speeds time to market.
Scalable – flexible solutions meet the needs of companies of every size.

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).

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.

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