Dietary Supplements

Quality Management Software for Dietary Supplement Companies Automates Processes Essential to Good Manufacturing Practices

On June 1, 2008, the FDA’s Good Manufacturing Practices (GMP) rule for dietary supplements went into effect for companies having more than 500 employees. The staggered phase-in for smaller companies is as follows:

June 1, 2009 for companies having between 21 and 499 employees
June 1, 2010 for companies having fewer than 20 employees

Companies that manufacture, package, label, or hold dietary supplements are required to follow the GMP rule.

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	White Paper: Final FDA Rule on Dietary Supplements - 21 CFR Part 111
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Regulatory Requirements for Manufacturers of Dietary Supplements

The FDA-issued GMP rule for dietary supplements (21 CFR Part 111) specifies quality requirements for assuring that dietary supplements are produced in a quality manner, are free of contaminants or impurities, and are accurately labeled. The regulation also requires companies involved in the manufacture, packaging, labeling, or holding of dietary supplements to maintain records and make them available for inspection by the FDA when requested to do so (section 111.610 of subpart P).

Dietary Supplement Quality Challenges

To ensure that the good manufacturing practices specified by the FDA are met, a company involved in the manufacturing, packaging, labeling, or holding of dietary supplements must address a number of challenges, including:

Inefficient Quality System: Establishing good manufacturing practices and maintaining records for manufacturing operations, customer complaints, corrective actions, deviations and nonconformances, employee competencies, etc., can be extremely challenging without an automated quality control system that integrates and documents the various quality processes.
Disconnected Processes: Quality processes that are not connected to one another can lead to delays and poor results. For example, a corrective action system that's not connected to the rest of the quality system may produce an unreliable root cause investigation due to inadequate information. In contrast, a corrective action system that is connected to detailed customer complaint and product investigation records ensures an effective corrective action process.
Unprepared for a GMP Inspection by the FDA: During an FDA inspection, companies must be able to quickly access their records in order to prove that, for example, customer complaints regarding a product defect were properly investigated. As part of this process, companies must also be able to show that the necessary corrective action(s) were taken, the relevant SOPs were updated, employees affected by the updated SOPs were retrained, etc. Without a unified quality control system for automating and tracking the appropriate actions, it can be very difficult to quickly access records—or, worse, access them at all.

MasterControl Integrated Quality Management Software Solution

MasterControl’s integrated quality management suite is a configurable, easy-to-use solution that can help dietary supplement companies attain and sustain compliance with FDA GMP regulations by automating the management of quality processes in an efficient and cost-effective manner.
MasterControl applications ensure the integrity of documents, manufacturing operations, and corrective actions. They also automate training of employees, documenting employee competencies, and performing other critical functions necessary for ensuring compliance to the GMP rule.

What Solutions Are You Looking For?

Roll over the list of solution categories below to view the related MasterControl product, then click to go to that solution's product page.


Audit Management
Batch Records
GCP Document Management
Document Control
Change Control
Corrective/Preventive Action
Training Management
Electronic Submissions
Customer Complaints
Supplier Management
Validation

MasterControl Documents™ helps increase the efficiency and effectiveness of each department by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation, making search and retrieval easy.

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.

MasterControl Training™ automates assignment and monitoring of training tasks and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed, the next one is automatically launched. Provides group sign-off feature for verifying training of large groups of employees. Training control can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.

MasterControl Submissions™ facilitates electronic delivery of FDA applications (such as IND, NDA, and BLA) by providing control in assembling and tracking necessary documentation. It provides appropriate templates to streamline the dossier-creation process. MasterControl can be integrated with leading e-submission applications, connecting approved documents and forms-based content with the dossier assembly process, to accelerate submissions.

MasterControl Customer Complaints™ streamlines the complaint-handling process and reduce the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with a resolution of the issue.

The FDA's 21 CFR Part 11 requires full-cycle validation of electronic record-keeping systems to assure the accuracy, reliability, and consistent intended performance of the system.

MasterControl GCPDocs JumpStart™ provides a solution for collecting, organizing, and reviewing all the documents required to meet GCP requirements.

MasterControl Supplier™ gives companies the capability to efficiently manage and approve vendor lists and effectively track supplier quality and supplier status.

MasterControl QAAD™ audit management software is the only off-the-shelf quality management solution that has been specifically developed for pharmaceutical quality groups.

MasterControl Batch Records™ is a powerful EBR management solution for automating and controlling batch processes. This automated EBR system will help ensure GMP compliance and increase efficiency in creating and managing master recipes and control recipes. For manufacturers automating their paper-based batch record systems for the first time, MasterControl meets all software-related requirements of Part 11.

MasterControl CAPA™ is a robust, easy-to-use system designed to effectively manage the corrective action / preventive action process and integrate it with other processes critical to regulatory compliance, such as change control, audit, and customer complaints. Here's how MasterControl CAPA addresses some of the major challenges that companies face in establishing and maintaining effective corrective and preventive action processes:

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