By Food and Drug Administration
The Compact Regs sequence offers full-text, pocket-sized structure (3 3/4 inch x five 0.5 inch) verbatim reproductions of key US FDA laws. The texts are entire and feature now not been altered in any demeanour from the unique resources. they're the best inexpensive instruments for: staff as a part of documented GMP education courses, for suppliers/vendors so they may supply parts, labels, and components with an figuring out of FDA requisites, and for every scientific investigator, nurse, and technician to aid guarantee compliance to medical trial protocols. A key-phrase index are available on the finish of every publication.
Read or Download Compact Regs Part 26: CFR 21 Part 26 Mutual Recognition: US and the European Community (10 Pack) PDF
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Additional info for Compact Regs Part 26: CFR 21 Part 26 Mutual Recognition: US and the European Community (10 Pack)
Example text
Ability to assess and evaluate research and development data as scientifically sound, especially transfer technology of pilot, scale up and full scale production batches. E. Ability to verify conformity of the onsite processes and procedures with those described in the application. F. Review and evaluate equipment installation, operational and performance qualification data, and evaluate test method validation. 29 APPENDIX E TO SUBPART A OF PART 26—ELEMENTS TO BE CONSIDERED IN DEVELOPING A TWO-WAY ALERT SYSTEM 1.
D. Ability to assess and evaluate research and development data as scientifically sound, especially transfer technology of pilot, scale up and full scale production batches. E. Ability to verify conformity of the onsite processes and procedures with those described in the application. F. Review and evaluate equipment installation, operational and performance qualification data, and evaluate test method validation. 29 APPENDIX E TO SUBPART A OF PART 26—ELEMENTS TO BE CONSIDERED IN DEVELOPING A TWO-WAY ALERT SYSTEM 1.
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: Director, Office of Compliance and Biologics Quality (HFM-600), 1401 Rockville Pike, Rockville, MD 20852, phone: 301-827-6190, fax: 301-594-1944. , Rockville, MD 20855-2737, phone: 301-594-0054, fax: 301-594-2114. , Rockville, MD 20855-2773, phone: 301-827-6644, fax: 301-594-1807.