By Sidney H Willig
content material: prestige and Applicability of U.S. laws: present stable production Practices in production, Processing, Packaging, and Holdings of DrugsFinished prescription drugs: normal Provisions (Subpart A)Organization and body of workers: (Subpart B)Buildings and amenities: (Subpart C)Equipment: (Subpart D)Control of parts and Drug Product boxes and Closures (Subpart E)Production and method Controls (Subpart F)Packaging and Labeling Controls (Subpart G)Holding and Distribution: (Subpart H)Laboratory Controls (Subpart I)Records and experiences (Subpart J)Returned and Salvaged Drug items (Subpart K)Repacking and RelabelingBulk Pharmaceutical ChemicalsThe Pharmacist and overall caliber ControlRecalls and CGMPs: Enforcement possible choices within the United StatesControlled ingredients Safeguards (21 CFR 1300, et seq.)The Inspection strategy for Compliance within the usa: The Regulatee Is Inspected;The purpose for Inspection (21 USC 373,374)FDA Pre-Approval Inspections/Investigations; the line from SUPAC to the nutrition and Drug Modernization ActWho is the producer? a few extra issues for the MultinationalOther GMPsOther techniques to QualityImport and Export of prescription drugs and different ProductsSubject to CGMPsEnhancement of world Product DistributionAppendix A: nutrition and Drug Modernization Act of 1997-in Pertinent PartAppendix B: Components/RepackagersAppendix C: listening to methods whilst FDA Proposes the Imposition of Civil cash PenaltiesAppendix D:Section 601.12 adjustments at the moment thought of "Important" by means of CBERAppendix E: USP24-NF19 details; Monographs; Tests
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Additional resources for Good manufacturing practices for pharmaceuticals : a plan for total quality control from manufacturer to consumer
Sample text
For readers interested in labeling for homeopathic drugs, see Chapter 8 below. The American Medical Association’s House of Delegates has expressed the view that dietary supplements should be required to meet USP compendial standards prior to marketing. This would put them in category not too unlike that of homeopathic drugs. That should not be, since homeopathic drugs, as discussed elsewhere, do make claims in areas of prevention, treatment, or mitigation of disease. Obviously there is some confusion here in the minds of physicians reflecting their consumer patients’ attitudes toward dietary aids.
Training programs must include appropriate evaluation steps. These will usually involve some type of evaluation at the end of each module followed by Copyright 2001 by Marcel Dekker, Inc. All Rights Reserved. on-the-job appraisal to confirm that the lessons learned have been put into practice. Repeat training should be initiated when necessary. The regular employee performance appraisal process should also identify further training needs—as refreshers to existing knowledge and skills, to meet the changing needs of the operation, or in preparation for a job change requiring additional skills.
The efforts of all personnel making product integrity decisions during processing must be coordinated and standardized to attain these desired levels. The materials and accompanying information flow through production must demonstrate that control, engineering, and production management have determined potential sources of error and have introduced control procedures to minimize the possibility. A model of material and information flows for operations should show complete quality control surveillance of all operations involved with drug production, adequate information exchange to monitor and control this surveillance, and records that document all activity.