♣ Non-Penicillin Beta-Lactam Drugs : A CGMP Framework for Preventing Cross-Contamination (PDF-70KB)

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

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♣ Computerized System in Drug Establishments

Computers are being used in increasing numbers in the pharmaceutical industry.  As microprocessors become more powerful, reliable, and less expensive we can expect the proliferation of this technology, with increasing use by even very small pharmaceutical establishments. Computer systems are used in a wide variety of ways in a pharmaceutical establishment, such as, maintenanceof quarantine systems for drug components, control of significant steps in manufacturing the dosage form, control of laboratory functions, management of warehousing and distribution activities.  Computer systems may control one or more of these phases, either singly or as part of a highly automated integrated complex.

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