Manufacturing

Good Manufacturing Practice (GMP) Compliance

Assure your quality system achieves Good Manufacturing Practice (GMP) compliance requirements.

The U.S. Food and Drug Administration's (FDA) current good manufacturing practice (cGMP) regulations are meant to ensure that pharmaceutical drugs are consistently produced and controlled according to quality standards, are safe for use and work as intended. Quality and compliance software helps manufacturers adequately address GMP compliance.

Free Resources

FDA and ISO Compliance for Pharmaceutical Manufacturers

GMP Compliance System Videos

Hundreds of companies rely on MasterControl to build quality into their products and processes.

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Free Resources on Pharma GMP Compliance

Choose the complimentary resources you're interested in downloading.

White Paper: Validating Software Systems to Comply with CGMP and 21 CFR Part 11 Regulations White Paper: GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems
Industry Brief: 8 Best Practices for Compliant and Quick Software Validation in the Cloud
Q&A: Q&A CDER Official Offers Tips on GMP Inspections
Insight Brief: 5 Ways MES Solutions Meet Pharma Manufacturing Needs
e-Book: FDA and ISO Compliance for Pharmaceutical Manufacturers

Overview of cGMPs

The FDA devised cGMP regulations to establish a foundation of requirements for drug product quality and enable a common understanding of the regulatory process. Compliance with the cGMP regulations requires that manufacturers adequately control manufacturing operations. This includes establishing a strong QMS and robust operating procedures, and identifying and addressing product quality deviations. The GMP guidelines are minimum requirements, with enough flexibility to allow manufacturers to determine the best methods of implementing the necessary controls. The flexibility allows companies to use modern technologies and approaches to achieve greater quality through continuous improvement.

cGMPS and Modern Quality Systems

In its "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations," the FDA identified seven concepts critical for modern quality systems.

Quality

Pharmaceutical products must establish identity, strength and other quality characteristics meant to ensure the required levels of safety and effectiveness.
Quality by Design and Product Development

Quality by design, in conjunction with a quality system, provides a sound framework for sharing product knowledge and process understanding.
Quality Risk Management

Quality risk management is a valuable part of an effective quality system framework. It includes implementing risk management controls commensurate with the level of risk.
Corrective and Preventive Action (CAPA)

CAPA as a cGMP regulatory concept focuses on investigating, understanding and correcting discrepancies while trying to prevent their recurrence.
Change Control

Change control focuses on managing change to prevent unintended consequences. Effective change control is a key part of any quality system.
Quality Unit

The quality unit refers to a group within an organization that promotes quality in general practice. Current industry practice generally divides the responsibilities of the unit between quality control (QC) and quality assurance (QA) functions.
Six-System Inspection Model

The six-system inspection model can help pharmaceutical manufacturers comply with cGMP regulations. It is composed of quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling.

The QMS Provider for the FDA

MasterControl 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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Good Manufacturing Practice (GMP) Compliance

GMP Compliance System Videos

Free Resources on Pharma GMP Compliance

Overview of cGMPs

cGMPS and Modern Quality Systems

Quality

Quality by Design and Product Development

Quality Risk Management

Corrective and Preventive Action (CAPA)

Change Control

Quality Unit

Six-System Inspection Model

MasterControl's Quality System Supports GMP Compliance

The QMS Provider for the FDA

Electronic Batch Record (EBR) Software

eDHR Software Systems

Recipe Management System

{{ midCont.kicker }}

{{ content.title }}

Good Manufacturing Practice (GMP) Compliance

GMP Compliance System Videos

Free Resources on Pharma GMP Compliance

Overview of cGMPs

cGMPS and Modern Quality Systems

Quality

Quality by Design and Product Development

Quality Risk Management

Corrective and Preventive Action (CAPA)

Change Control

Quality Unit

Six-System Inspection Model

MasterControl's Quality System Supports GMP Compliance

The QMS Provider for the FDA

Electronic Batch Record (EBR) Software

eDHR Software Systems

Recipe Management System

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