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Facilities & Support Resource Center
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Facility of the Year Award Winner: Bristol-Myers Squibb
Facility of the Year Winner: F. Hoffmann La Roche AG
FDA on Career Applicant Pool: What You Need to Know
Facility of the Year Winner: Boehringer Ingelheim Pharma GmbH & Co.KG |
White Papers: In depth research
| Title | Author | Date |
| How to Prepare for an Inspection of Your Company's Information Integrity | Cerulean Associates LLC | 07/25/2007 |
| Last year, 95% of all regulatory enforcement focused on one topic: the integrity - or lack thereof - of a company's information. Cerulean recommends the steps to prepare for an inspection of information integrity. | ||
| Five Key Steps to Minimizing Risk During GMP Site Renovations | John Buescher and Tom Kreher, McCarthy Building Companies | 01/23/2007 |
| Renovating any facility while manufacturing is going on poses a number of risks. This position paper by John Buescher and Tom Kreher of McCarthy Building Companies outlines top priorities and how to address them. | ||
| FDA-CDER Compliance Policy Guide for the PDMA | FDA Center for Drug Evaluation and Research | 11/13/2006 |
| This document is intended to clarify for FDA personnel and the regulated industry how the agency intends to prioritize its enforcement efforts regarding the pedigree requirements in 21 U.S.C. 353(e)(1)(A) and 21 CFR Part 203 during the first year after the effective date of 21 CFR §§ 203.3(u) and 203.50. | ||
| Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations | FDA Center for Drug Evaluation and Reseacb | 10/09/2006 |
| This guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211). The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products. | ||
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