Current Good Manufacturing Practice Design Trends in Active Pharmaceutical Ingredients Facilities
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CURRENT GOOD MANUFACTURING PRACTICE DESIGN TRENDS IN ACTIVE PHARMACEUTICAL INGREDIENTS FACILITIES LOUISA. ANGELUCCI, I11 Director, Worldwide Validation, Pharmaceuticals and Life Sciences, Foster-Wheeler USA Corporation, Clinton, New Jersey
Since the early 1990s, the Food and Drug Administration (FDA) has focused attention on Good Manufacturing Practice (GMP) compliance within the active pharmaceutical ingredients (API) industry. Over the years, as well as recently, this industry has striven to play catch-up and comply. This paper discusses both general and specific API industry trends associated with this increased compliance effort. Key Words: GMPs; Compliance; Validation; MIS;Facility; Trends
INTRODUCTION
GMP compliance and validation. For that matter, there were even questions of how early in the process and to what degree GMP compliance had to be taken. In 1996, to help deal with these issues, the FDA published a Draft API Guide. This document explains many expectations of the FDA, especially as they relate to GMPs and validation. As a result, several trends have become evident in the API industry which are discussed in this paper.
THERE IS PLENTY OF controversy in the pharmaceutical industry regarding GMP compliance and APIs. It was not too long ago when the FDA agreed to use the term “API.” The FDA’s first guide on bulk pharmaceutical chemicals refers to the active ingredient and states that this is where validation and qualification are required. “API” is also a term that was being used in Europe when, in this country, we were still referring to all bulk production processes as “BPC” processes. In the early 1990s, the FDA began its unannounced inspections on the application of GMPs to API facilities. The 1991 BPC Guide left a lot to the imagination with regard to
GENERALTRENDS
Presented at the DIA Fourth Symposium on Active Pharmaceutical Ingredients “Issues at the Development, Production, Regulatory Interface,” November 8-1 1, 1998, Baltimore, Maryland. Reprint address: Louis A. Angelucci, 111, FosterWheeler USA Corporation, Penyville Corporate Park, Clinton, NJ 088094000.
Today there is an awareness and consciousness of CGMPs and their application to API production (Table 1). Most facilities that manufacture bulk pharmaceutical chemicals apply quality principles. There is awareness that a quality unit is required and that it must be independent from the manufacturing department. The importance of traceability and proper documentation is also recognized, as well as the need to incorporate online testing and sampling. From the inception of the process to the
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TABLE 1 General GMP Design Trends
Awareness and consciousness of cGMPs Across the board application of cGMPs Emphasis on validation for recommended application in API Guide Prevention of product adulteration
very end, there is an awa
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