Good Manufacturing Practices for pharmaceuticals, a plan for total quality control from manufacturer to consumer-M. Dekker  (2000) 

Good Manufacturing Practices for pharmaceuticals, a plan for total quality control from manufacturer to consumer-M. Dekker  (2000)

Partisan bickering in the Congress of the United States, with added hostility be-tween the President and the legislature, has occasioned much news media atten-tion in 1999. So, in the United States, as in Europe and Japan, there continues growing political appeal in pressing drug manufacturers for price concessions in response to the problem of funding national health care systems. This has added to consideration of the economy of drugs, biologicals, vaccines, and medical devices; a lesser tolerance for growth in research costs; and a greater demand for reduction in manufacturing outlay. Much healthy innovation in Current Good Manufacturing Practices (CGMPs) will occur, but at some risk. Media criticism of promotional expenses can be anticipated.

Because this edition continues insights requisite to the multinational activi-ties of most manufacturers today, we take note of scientific and legal factors to a greater extent than before. The text contains guidelines that address these factors and questions that the reader will want to analyze in detail and update. We urge our readers to be alert to millennial revisions, additions, and deletions to pub-lished standards on which they presently rely. For example, in USP24-NF19, there have been more than 3900 revisions.

The audience for this book is broader than just those involved in the manu-facture of pharmaceuticals. This is an invaluable resource for private and indepen-dent inspection personnel, local and state inspection agencies, and quality assur-ance organizations contracted by distributors, and reflects the growing role of pharmacists acting as employees, or independently, in some aspect of quality control.

With these caveats in place, the efforts, responsibilities, and commitments of governmental authorities and private industry will continue to focus on main-taining CGMPs for pharmaceuticals.

A drug or device shall be deemed to be adulterated—(a)(2)(b) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to as-sure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. (21 USC 351)

As experience with federal courts in the United States has indicated, the CGMP regulations are usually held to be substantive and have been used to support the strictest of sanctions by their breach. These regulations truly apply to all drugs, whether or not they are characterized as old drugs; new drugs; Abbreviated New Drug Application (ANDA) drugs; investigational drugs; or ingredients of drugs, devices, or cosmetics. Since the inception of these regulations, if the FDA can establish that the regulatee has not conformed to CGMPs in its procedures, the FDA can allege that the resultant products are adulterated, whether or not they are currently distributed nationally or abroad. Then it may invoke all of its reme-dies as feasible against the product itself, as well as against the parties responsi-ble, whether corporate or individual, national or extranational.

Current Good Manufacturing Practices have taken on new significance in this era of multinational suppliers of pharmaceuticals. Cross-licensing, joint ven-tures, strategic alliances, mergers, acquisitions, and divestitures underscore the necessity of maintaining standards of manufacturing and quality control across the geographical boundary of suppliers and distributors. In this edition, we offer enhanced definition of these activities.

Advances in the design of pharmaceuticals, to at once expand and make more specific their applicability to modern medical armamentaria, have added complexities to the entire production process, on through to packaging and stor-age. Added to this are the growing concerns of adulteration and misbranding, given the potency of many new products.

As if sheer medical and scientific progress were not enough to spur greater concern over CGMPs, new regulatory stress and the impact of legislation have enhanced the responsibilities of manufacturers and other suppliers. New regula-tory enforcement, carrying stiff penalties, has been established.

Where other regulated materials have cast a particular light on quality con-trol needs of the distributor by court decisions or legislative or administrative action, they have been noted in this edition.

Hand in hand with this are new enforcement alternatives via the statutory scheme, which threaten imposition of criminal sanctions on wrongdoers. To this end, there has been increased enlistment and training of government regulatory investigators.

The fifth edition of Good Manufacturing Practices for Pharmaceuticals both expands on and compresses the considerable material used in composing prior editions. As such, and because of their number, it becomes more difficult to identify contributors. Suffice it to say that the excellent advice of prior coau-thors such as Drs. Murray M. Tuckerman, William S. Hitchings IV, and James R. Stoker has been enriched by years of cumulative experience and regulatory interaction. This edition also reflects the cooperation of many private, industrial, and governmental employees on all levels and, where possible, citations have been offered for reference. Among those I would especially note and thank for their courtesy, comments, and assistance are James Ruger, Ph.D., J.D.; Kenneth C.H. Willig, Ph.D, J.D.; and Randi Cane.


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