USP Quality Systems GMP Audited Verification Program

USP Quality Systems GMP Audited Verification Program

Manual for Participants

USP Quality Systems GMP Audited Verification Program

BUILDING TRUST and CONFIDENCE

Manual for

Participants

a USP Quality Systems GMP Audited Verification Program. ? January 2016, U.S. Pharmacopeial Convention. All rights reserved.

USP Quality Systems GMP Audited Verification Program

Manual for Participants

Notice

This manual provides guidance to dietary supplement1 manufacturers who intend to participate in the United States Pharmacopeia's Quality Systems GMP Audited Verification Program (USP QS GMP Audited Program, or Program). Additional requirements and criteria that are not included in this manual, including those in the USP Quality Systems GMP Audited Mark Usage Manual, must be satisfied for participation. Prospective Participants are advised to discuss these additional requirements with the United States Pharmacopeial Convention (USP).

The USP QS GMP Audited Program is designed to assist Participants in assuring their customers that a manufactured product is produced in accordance with current Good Manufacturing Practices (GMPs) and that the Participant's GMP quality systems comply with the Program requirements. USP considers this a cooperative effort between USP and Participants. Participants who meet the requirements of this Program will receive permission to use the special USP Quality Systems GMP Audited Mark on the Participant's business-to-business website, trade promotion, and advertising.

Barring safety concerns or other special circumstances, USP maintains the confidentiality of information gained through the quality systems GMP audited process in accordance with the provisions of the Program License Agreement, provided separately.

1 USP understands that the term dietary supplement as used in the United States has different meanings in other countries. Non-U.S. terms include botanicals, herbals, herbal medicines, nutraceuticals, food supplements, and natural health products.

b USP Quality Systems GMP Audited Verification Program. ? January 2016, U.S. Pharmacopeial Convention. All rights reserved.

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Manual for Participants

USP Quality Systems GMP Audited Verification Program

Manual For Participants

Table of Contents

Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Criteria for Participation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Required Process and Submissions . . . . . . . . . . . . . . . . . . . . . . . 2 Process Overview Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Evaluation of Intitial Quality Systems Audit Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 On-Site Qualtiy Systems GMP Audit. . . . . . . . . . . . . . . . . . . . . . . .7 USP Notification of Nonconformties. . . . . . . . . . . . . . . . . . . . . . 12 Issuance of the USP Quality Systems GMP Audited Mark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Need for Annual Quality Systems GMP Audits . . . . . . . . . . . . . 16 Need for Re-evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Appeals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Product Recalls and Suspension of the Mark . . . . . . . . . . . . . . 18 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Forms and Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

? Section I: Participant's Declaration of Information Fulfilling Initial Quality Systems Audit Documentation Request

? Section II: Checklist for On-Site Quality Systems GMP Audit Legal Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

c USP Quality Systems GMP Audited Verification Program. ? January 2016, U.S. Pharmacopeial Convention. All rights reserved.

USP Quality Systems GMP Audited Verification Program

Manual for Participants

1. Overview

The USP Quality Systems GMP Audited Verification Program (USP QS GMP Audited Program, or Program) is one of several public health programs of the USP. Participation is voluntary and open to companies manufacturing dietary supplement products.

The USP QS GMP Audited Program covers the quality systems used in a facility to manufacture dietary supplements legally marketed under the Dietary Supplement Health and Education Act (DSHEA), including vitamins, minerals, amino acids, botanicals, and other non-botanical dietary supplement products. The Program complements the United States Food Drug Administration's (U.S. FDA's) regulation of dietary supplements under DSHEA and the Good Manufacturing Practice (GMP) regulations contained in 21 Code of Federal Regulations Part 111 (21 CFR Part 111).

The USP QS GMP Audited Program includes: Evaluation of manufacturers' quality systems by an audit to establish conformity with USP and FDA GMPs.

Granting use of the USP Quality Systems GMP Audited Mark and issuance of a Certificate of Standards Compliance upon obtaining conformity with the Program requirements.

Annual Quality Systems GMP audits of facilities using the USP Quality Systems GMP Audited Mark (Mark) to ascertain continuing conformity with Program requirements.

The use of the distinctive USP Quality Systems GMP Audited Mark is granted for dietary supplement manufacturing facilities that successfully meet USP QS GMP Audited Program requirements. The Mark indicates verification that the manufacturing facility quality system has met USP's requirements under the Program. It provides assurance that the manufacturer's quality system helps to ensure that dietary supplements will be manufactured in accordance with applicable GMPs.

1 USP Quality Systems GMP Audited Verification Program. ? January 2016, U.S. Pharmacopeial Convention. All rights reserved.

USP Quality Systems GMP Audited Verification Program

Manual for Participants

2. Criteria for Participation

Participants in the USP Quality Systems GMP Audited Program agree to: Sign the license agreement. Submit requested documentation. Subject their facilities to all reviews, inspections, and audits specified in the Program. Abide by the decisions made in accordance with the requirements of the USP Quality Systems GMP Audited Verification Program as specified in this manual, the USP Quality Systems GMP Audited Mark Usage Manual, and the Program License Agreement. Operate in compliance with applicable laws and regulations. Register the facility under the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Pay all fees required by USP agreements or by documents executed between the Participant and USP.

3. Required Process and Submissions

Participants in the USP Quality Systems GMP Audited Program shall: Appoint a duly authorized representative to execute a "License Agreement." Provide the list of manufacturing sites for which quality systems GMP auditing is sought. Enable USP to enter manufacturing facilities and perform on-site audits.

2 USP Quality Systems GMP Audited Verification Program. ? January 2016, U.S. Pharmacopeial Convention. All rights reserved.

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