Partie 111 du titre 21 du CFR

Contrôles utilisés lors de la fabrication, la transformation, l’emballage ou le stockage des compléments alimentaires conformément aux règlementations relatives aux bonnes pratiques de fabrication dans l'industrie pharmaceutique (partie 111 du titre 21 du CFR de la FDA)

En juin 2007, la FDA a publié la Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule FDA 21 CFR Part 111 (règle finale des bonnes pratiques de fabrication actuelles pour les compléments alimentaires). Par nature, elle exige de mettre en place des contrôles appropriés pour les compléments alimentaires lors de la fabrication, l'emballage, l’étiquetage et le stockage. Cette décision répondait aux inquiétudes concernant les pratiques de fabrication des compléments alimentaires de qualité inférieure, comme le mauvais étiquetage.

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La partie 111 du titre 21 du CFR de la FDA concerne la qualité des procédés de fabrication des compléments alimentaires, ainsi que le listage des ingrédients que ces derniers contiennent. Elle ne régit pas l’accès aux compléments alimentaires et ne traite pas de l’innocuité des ingrédients ni de leurs effets sur la santé. Cette règlementation s’applique à toutes les entreprises nationales et étrangères qui fabriquent, emballent, étiquettent ou stockent des compléments alimentaires, y compris celles chargées des tests, du contrôle qualité et de la distribution des compléments alimentaires aux États-Unis.

MasterControl, fournisseur de logiciels de premier plan pour le secteur des sciences de la vie et d’autres réglementés, propose une solution logicielle configurable, facile à utiliser et intégrée pour vous aider à vous conformer à ces exigences. Voilà comment:

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.

Conformité : respect durable de la partie 111 du titre 21 du CFR de la FDA

Année après année, MasterControl vous aide à respecter ces dispositions, tout en réduisant les coûts liés à la conformité.

Interconnexion : intégration des produits de gestion de la qualité, conforme à la partie 111 du titre 21 du CFR de la FDA

MasterControl est une solution connectée qui vous permet de surveiller le système qualité dans son intégralité et de l'améliorer en permanence.

Exhaustivité : une application à l'échelle de l'entreprise pour la conformité à la partie 111 du titre 21 du CFR de la FDA

MasterControl est une solution complète qui répond aux besoins de tous les départements et aux dispositions de la FDA pour que toutes les actions liées à la qualité soient mises en œuvre à l'échelle de l'entreprise.