Compliance 21 CFR Regulations


FDA 21 CFR Part 111

Controls Used for Manufacturing, Processing, Packing, or Holding Dietary Supplements for FDA 21 CFR Part 111 CGMP Regulations

In June 2007, the FDA issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule FDA 21 CFR Part 111. In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations. The move was in response to concerns about substandard dietary supplement manufacturing practices, as well as mislabeling practices.

Solutions to 21 CFR Part 111 Challenges

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The FDA 21 CFR Part 111 ruling addresses the quality of the manufacturing processes for dietary supplements and the accurate listing of supplement ingredients. It does not limit consumers' access to dietary supplements; nor does it address the safety of the dietary supplements ingredients, or their effects on health, when proper manufacturing techniques are used. The rule applies to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with testing, quality control, and dietary supplement distribution in the U.S.

MasterControl Inc., a leading software provider for the life sciences industry and other regulated industries, provides a configurable, easy-to-use, and integrated software solution to help companies comply with FDA 21 CFR Part 111 and other FDA regulations. Here's how the MasterControl GxP process and document management products address 21 CFR Part 111 requirements:

FDA 21 CFR Part 111 - Sections 111.103 & 111.105 of subpart F

Under sec. 111.103 of subpart F, you must establish and follow written procedures for the responsibilities of quality control operations which actually comply with FDA 21 CFR Part 111 regulations; these include written procedures for conducting a material review and making a disposition decision and for approving or rejecting any reprocessing. Under sec. 111.105 of subpart F, quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement. Furthermore, the dietary supplement must be packaged and labeled as specified in the master manufacturing record.

MasterControl Documents™ automates routing, escalation, approval, and delivery of SOPs, policies, and other documentation required for FDA 21 CFR Part 111 requirements. The software provides a secure, centralized Web-based repository that's accessible to all authorized users. MasterControl provides automatic revision control to ensure that only the current version of an SOP is available. When a user makes a change to 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.

FDA 21 CFR Part 111 - Sections 111.12(c), 111.13 & 111.14(b) of subpart B

Under sec. 111.12(c) of subpart B, each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operation, must have the education, training, or experience to perform the person's assigned functions. In addition (under sec. 111.13 of subpart B), qualified personnel must be assigned to supervise the manufacturing, packaging, labeling, or holding of dietary supplements, and each supervisor must be qualified by education, training, or experience to supervise. Under sec. 111.14(b) of subpart B, you must make and keep the following records: written procedures for fulfilling the FDA 21 CFR Part 111 requirements of subpart B; and documentation of training, including the date of the training, the type of training, and the person(s) trained.

MasterControl Training™ automates the assignment and monitoring of training tasks and the grading of online exams to ensure each person completes their respective required training. It also allows training courses to be sequenced, so that after a prerequisite is completed, the next course is automatically launched. A group sign-off feature facilitates the verification of training for large groups of employees.

21 CFR Part 111 - Section 111.70(a) & sec. 111.70(c)2 of subpart E

Under sec. 111.70(a) of subpart E, you must establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Under Sec 111.70(c)2 of subpart E, you must provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications for FDA 21 CFR Part 111 are met for the identity, purity, strength, and composition of the dietary supplement and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement.

MasterControl Deviations™ automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures and specifications. This solution provides the capability to resolve a deviation efficiently and to use data collected as a basis for continuous quality improvement which is FDA 21 CFR Part 111 compliant.

21 CFR Part 111 - Section 111.570(b)2(ii) of subpart O

Written records of product complaints must be kept and must include the (A) the name and description of the dietary supplement; (B) the batch, lot, or control number of the dietary supplement, if available; (C) the date the complaint was received and the name, address, or telephone number of the complainant, if available; (D) the nature of the complaint including, if known, how the product was used; (E) the reply to the complainant, if any; and (F) findings of the investigation and follow-up action taken when an investigation is performed.

MasterControl Customer Complaints™ streamlines the handling of complaints via a simple, three-step process that is incorporated into a pre-configured, automated form. Once information about the complaint has been entered into the form, the process moves to an internal investigation, and culminates with the resolution of the complaint. The solution 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 according to FDA 21 CFR Part 111 regulations.

FDA 21 CFR Part 111 - Section 111.75 (i) of subpart E and Section 111.530 of subpart N

Under sec. 111.75 (i) of subpart E, you must establish corrective action plans when an established specification is not met. Furthermore (under 111.530 of subpart N), if a dietary supplement is returned and the reason for the return implicates other batches, you must conduct an investigation of your manufacturing processes on each of those other batches to determine compliance with FDA 21 CFR Part 111 specifications.

MasterControl CAPA™ integrates the corrective action/ preventive action process with other quality processes. The solution provides the best-practice "8D" process that guides the quality team through every step of CAPA. A CAPA form can be launched directly from another form (e.g., a nonconformance report). The system automatically enters relevant data into a CAPA form, reducing data entry and eliminating errors that can result from the manual transfer of information. In addition, the software provides customizable reporting capabilities to help managers monitor the entire quality management life cycle according to FDA 21 CFR Part 111 regulations.

F 21 CFR Part 111 - Section 111.120(b) of subpart F

According to sec. 111.120(b) of subpart F, the quality control operations team must determine whether dietary supplement components, packaging, and labels conform to specifications established under sec. 111.70 (b) and (d) of Part E (which establishes component, labeling, and packaging specifications for ensuring the quality of a dietary supplement.

MasterControl Nonconformance™ is designed to automate, manage, and streamline the process for identifying, evaluating, and handling nonconforming components and finished products. The solution's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a FDA 21 CFR Part 111 nonconformance.

Compliant - Sustained Compliance for FDA 21 CFR Part 111

MasterControl is fully compliant, which can help you meet FDA 21 CFR Part 111 regulations year after year, while keeping compliance costs down.

Connected - Integrated Quality Management Products for FDA 21 CFR Part 111

MasterControl is connected, which gives you the ability to monitor the entire quality system and continuously improve it.

Complete - Enterprise-wide Product Application for FDA 21 CFR Part 111

MasterControl is complete, which means that it meets every department's needs and FDA 21 CFR Part 111 requirements to ensure quality processes across the enterprise.

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