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cGMP / GTP / QSR / GLP Consulting

Facility Design Manufacturing Quality Audit Training Due Diligence FDA / CMC 

       

Our firm helps commercial and academic organizations navigate their course through the FDA laws, regulations and guidelines that are required for success within this highly regulated and challenging environment.

We specialize in the manufacture of products made or associated with cell-based technology:

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Recombinant Proteins.

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Monoclonal Antibodies.

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Gene Therapy and Cell Therapy.

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Stem Cells.

This website includes information about our consulting services and other information that may be of benefit to our clients.  The following is a general discussion of the FDA's manufacturing requirements:

US manufacture of pharmaceutical and biopharmaceutical products must comply with defined minimum standards set forth by the FDA.  These standards are contained within specific Federal Laws:

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The Federal Food Drug and Cosmetic (FDC) Act (1938 - Drugs and Biologics).

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The Public Health Service Act (1944 – Biologics).

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Medical Device Amendments (1976).

These laws are delineated in regulations (US Code of Federal Regulations), which have the force of law and may be enforced by the FDA through the Federal Court System.  For example:

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cGMPs - 21 CFR 210, 211:  PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS.

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GTPs - 21 CFR PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE–BASED PRODUCTS.

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QSRs - 21 CFR 820:  PART 820—QUALITY SYSTEM REGULATION (Medical Device GMPs).

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GLPs - 21 CFR 58:  PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES.

The FDA provides guidelines to assist manufacturers in understanding these laws and regulations.  While the guidelines are "voluntary" in principle, they represent both the FDA's current interpretation of the regulations and the FDA's expectations for industry compliance.

Companies or academic organizations that operate within the state of California must also comply with the California Health and Safety Code Section:  Sherman Food, Drug, and Cosmetic Laws.  This law requires a CA Drug Manufacturing License (drugs and biologics) or a CA Medical Device Manufacturing License for all manufacturers, prior to shipment of their first human use product.  There is no exception for clinical manufacturing.  These licenses may only be obtained following an on-site inspection conducted by the FDB (Food and Drug Branch of the CA Department of Health Services).  We assist our California clients in preparing for this inspection.

Articles to Download:  

Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biologics"; Abstract and Presentation by W.R. Tolbert at the  March 30, 2007 AOAC-SCS Regulatory & Compliance Conference

Back to the Future:  Today’s innovators are breaking new ground, just as we did three decades ago.  This time, the process is accelerated, as scientists learn from the past - W.R. Tolbert, BioPharm International, October 2007.

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