cGMP COMPLIANCE FOCUSES ON CRITICAL ISSUES CONFRONTING BULK AND FINISHED PHARMACEUTICAL MANUFACTURING
cGMP COMPLIANCE FOCUSES ON CRITICAL ISSUES CONFRONTING
BULK AND FINISHED PHARMACEUTICAL MANUFACTURING
SOMERSET, N.J., April 7 /PRNewswire/ -- In a seminar presented at the International Society for Pharmaceutical Engineering (ISPE), Richard Lesnik, director of pharmaceutical technology with Jacobs Engineering Group Inc. (NYSE: JEC) stated that, "Awareness of the changes in interpretation of the cGMPs and the need to understand the importance of the 'c' for 'current' are critical for today's biopharm industry." In his remarks, delivered to an audience of top specialists in the industry meeting in Puerto Rico, Lesnick focused on three major areas of concern: the ever-changing maze of FDA issues that are subject to individual interpretation; cost effective design which takes into consideration FDA, EPA, USDA and NIH regulations to assure quality, purity and batch- to-batch consistency of the end product; and the importance of a well- planned validation process which must start during project definition.
Lesnik's 30 years of experience in various segments of the pharmaceutical industry prompted him to predict that regulations will become more strict. "If a company is doing something better today, that 'something' will become a regulation tomorrow. This is guaranteed under the current climate of regulation, today."
Other topics discussed at the two-day conference included how manufacturing, materials control, quality control/quality assurance, packaging, labeling and personnel training functions must comply with cGMP regulations. It also included a discussion of the legal basis for cGMP as described in the Federal Food, Drug and Cosmetic Act, as well as practical insights into FDA interaction and inspections, provided by FDA staff personnel.
Additional topics included the design and validation of pharmaceutical facilities and processes, the application of cGMPs to bulk pharmaceutical plants and the need for validation of bulk pharmaceutical facilities and processes.
Jacobs Engineering Group, headquartered in Pasadena, Calif., provides single-source consulting, engineering, design, architectural, environmental and hazardous waste management, procurement, construction, construction management, contract maintenance and operations services to government and industry worldwide. Jacobs has 22 offices located throughout the United States and Ireland.
/CONTACT: Stefanie Spikell of Jacobs Engineering Group, 818-578-6835/
(JEC) CO: Jacobs Engineering Group Inc.; International Society for
Pharmaceutical Engineering ST: New Jersey, California IN: CST MTC SU: ::EMD DM-JL -- LA007 -- 5675 04/07/92 08:04 EDT