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Title 21Chapter ISubchapter APart 26Subpart A → Appendix


Title 21: Food and Drugs
PART 26—MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
Subpart A—Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices


Appendix E to Subpart A of Part 26—Elements To Be Considered in Developing a Two-Way Alert System

1. Documentation

—Definition of a crisis/emergency and under what circumstances an alert is required

—Standard Operating Procedures (SOP's)

—Mechanism of health hazards evaluation and classification

—Language of communication and transmission of information

2. Crisis Management System

—Crisis analysis and communication mechanisms

—Establishment of contact points

—Reporting mechanisms

3. Enforcement Procedures

—Followup mechanisms

—Corrective action procedures

4. Quality Assurance System

—Pharmacovigilance programme

—Surveillance/monitoring of implementation of corrective action

5. Contact Points

For the purpose of subpart A of this part, the contact points for the alert system will be:

A. For the European Community:

the Executive Director of the European Agency for the Evaluation of Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London E14 4HB, England. Telephone 44-171-418 8400, Fax 418-8416.

B. For the United States :

Biologics:Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002, telephone: 240-402-9153, FAX: 301-595-1302.

Human Drugs: Director, Office of Compliance, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, phone: 301-796-3100, fax: 301-847-8747.

Veterinary Drugs: Director, Office of Surveillance and Compliance (HFV-200), MPN II, 7500 Standish Pl., Rockville, MD 20855-2773, phone: 301-827-6644, fax: 301-594-1807.

[63 FR 60141, Nov. 6, 1998, as amended at 69 FR 48775, Aug. 11, 2004; 74 FR 13112, Mar. 26, 2009; 80 FR 18090, Apr. 3, 2015]

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