Gmp farmaceuticas

Guidance for Industry
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) August 2001 ICH

E:\092401\GDLNS\ichactive.doc 09/25/01

Guidance for Industry
Q7A Good ManufacturingPractice Guidance for Active Pharmaceutical Ingredients
Additional copies are available from: Office of Training and Communications Division of Communications Management Drug Information Branch, HFD-210 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 (Internet) http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center forBiologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 Internet: http://www.fda.gov/cber/guidelines.htm. Fax: 1-888-CBERFAX or 301-827-3844 Mail: the Voice Information System at 800-835-4709 or 301-827-1800

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Centerfor Biologics Evaluation and Research (CBER) August 2001 ICH

Table Of Contents

I.
A. B. C.

INTRODUCTION (1)............................................................................................................ 1
Objective (1.1) .................................................................................................................... 1 Regulatory Applicability(1.2)............................................................................................. 2 Scope (1.3) .......................................................................................................................... 2

II. QUALITY MANAGEMENT (2)........................................................................................... 5
A. B. C. D. E. Principles(2.1).................................................................................................................... 5 Responsibilities of the Quality Unit(s) (2.2)...................................................................... 5 Responsibility for Production Activities (2.3).................................................................... 6 Internal Audits (Self Inspection)(2.4)................................................................................ 7 Product Quality Review (2.5) ............................................................................................. 7

III. PERSONNEL (3) ................................................................................................................... 8
A. B. C. Personnel Qualifications (3.1)............................................................................................ 8 Personnel Hygiene (3.2)..................................................................................................... 8 Consultants (3.3)................................................................................................................. 9

IV. BUILDINGS AND FACILITIES (4).................................................................................... 9
A. B. C. D. E. F. G. Design and Construction (4.1)............................................................................................ 9 Utilities (4.2) ..................................................................................................................... 10 Water (4.3)........................................................................................................................ 10 Containment (4.4) ............................................................................................................ 11 Lighting (4.5) .................................................................................................................... 11 Sewage and Refuse...