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Abstract

The computerization of the pharmaceutical industry has been progressing at a rapid pace and no end to these advances is in sight. The proliferation of this technology has required the Food and Drug Administration (FDA) to focus more closely on the Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) implications of the use of computer hardware and software in numerous aspects of the business of the pharmaceutical manufacturer. Computers are involved in the control of laboratory function, material review and analysis functions, and manufacturing operations.¹ One of the most important aspects of the FDA review of the GMP and GLP implications of the computerization of the pharmaceutical establishment is the need to ensure that the software component is properly validated. This article addresses the statutory and regulatory basis of the FDA's jurisdiction and then analyzes the legal implications of the FDA's activities in this area.

Keywords

Software validation Good manufacturing practices Computer systems Good laboratory practices FDA

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References

Guide to Inspection of Computerized Systems in Drug Processing, Food and Drug Administration (1983), 1. (hereinafter the “1983 Guide“). This guide does not actually explain how to validate and document computerized systems that control manufacturing processes or that automate laboratory procedures. Nor is the guide binding on pharmaceutical manufacturers or FDA inspectors. However, it is an extremely helpful ***outline of FDA's views on the important areas of the computerized systems that must be scrutinized. The agency is presently developing a more specific guide that would deal only with the inspection of software development activities (the software life cycle).

21 USC §§351, 371 (1982); see also §374, setting forth the parameters of factory inspection.

21 CFR Part 211 (1987).

1983 Guide, 16–19.

21 CFR §192 (1987) (access to computerized quality control records); id §211.101(d) (access to double check of batch verification if computerized); id §211.188(b) (11) (access to computerized batch production and control records for verification of identification of persons performing or supervising each significant operation step); id. §211.188(a) (allows verification of reproduction of master record if computerized); id §314.8 (if firm changes manufacturing/control processes from those stated in new drug application (NDA) ie, manual to computerized systems, then an NDA supplement may be required).

US v An Article of Drug.; White Quadrisect, 484 F2d 748 (7th Cir) (1973).

21 USC §§331(a), (e), (f), (g); 332, 333, 334, (1982). Admittedly, FDA rarely brings an enforcement action for violation of GMPs unless the agency has perceived a pattern of violations indicating that the company is out of control.

Kuzel

: Fundamentals of computer system validation and documentation in the pharmaceutical industry, Pharmaceutical Technology, 60 (1985) (hereinafter “Kuzel“).

Motise

: Validation of computer systems in drug production-An FDA perspective, presentation to PMA Seminar (January 1984) (hereinafter “Motise“).

10.

Motise, p 7; 1983 Guideline p 12.

11.

Schenbeck v Sterling Drug, Inc, 423 F2d 919 (8th Cir) (1970); Wooderson v Ortho Pharmaceutical Co, 235 Kan 387, 681 P2d 1038 (1984).

12.

Dixon, Drug Product Liability §6.04 (1983); Condon, “Product Liability-1984,” 40 Food Drug Cosm LJ 508, 512 (1985); Restatement (Second) of Torts §402A (1965).

13.

Dixon, Drug Product Liability §6.04 [1] (1983).

Legal Implications of Software Validation

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