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Topic: Regulatory Compliance
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Heparin Drama Underscores Need for More FDA Funding and Supplier Oversight
Mapping A Path to Quality Systems
Management of Change: Every Plant for Itself!
The Greening of Pharma |
White Papers: In depth research
| Title | Author | Date |
| A Perspective on Standards: A Tool for Global Competitive Survival in an Increasingly Complex Regulatory World | Rockwell Automation | 02/22/2008 |
| This paper by Rockwell Automation features executive viewpoints from leading standards, trade and conformity assessment organizations on why standards and regulations are important to global business, and why industry should care. | ||
| Amendment to the cGMP Regulations for Finished Pharmaceuticals | FDA | 12/07/2007 |
| The FDA is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Amending the regulations will modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. | ||
| Official File : Novartis Complaint | 07/27/2007 | |
| This is the official filed action against Novartis Pharmaceutical Corporation for violating a whistleblower's rights under the New Jersey Conscientious Employee Protection Act and retaliating against him for refusing to participate in illegal and unethical activities regarding the testing and reporting of human drug study results concerning Novartis' new cancer drug, Tasigna. | ||
| 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. | ||
| Draft Guidance : Bioequivalence Recommendations for Specific Products | Food & Drug Administration | 06/04/2007 |
| This guidance describes FDA’s process for making available to the public FDA guidance on how to design bioequivalence studies for specific drug products to support abbreviated new drug applications. Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site, rather than having to request this information from the Agency and wait for the Agency to respond, as has been the case in the past. The FDA believes that making this information available on the Internet will streamline the guidance process, making it more efficient than the previous process. | ||
| Unlocking the Power of Pharmacovigilance | PriceWaterhouse Coopers | 05/28/2007 |
| The idea that controlled clinical trials can establish product safety and effectiveness is a core principle of the pharmaceutical industry. Neither the clinical trials process nor the approval procedures of the FDA, however, can provide a perfect guarantee of safety for all potential consumers under all circumstances. Despite this fact, there are viable solutions that pharmaceutical companies can implement to support pharmacovigilance—the systematic detection, assessment, understanding and prevention of adverse drug reactions. Currently pharmaceutical executives face a number of challenges in the area of pharmacovigilance.The full version of this report provides insights that can guide companies as they contemplate the actions they will take to create this framework and foster the culture necessary to support it. | ||
| Guidance for Industry: Computerized Systems in Clinical Investigations | U.S. FDA (CDER, CBER, CDRH) | 05/10/2007 |
| This document provides to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and institutional review boards (IRBs), recommendations regarding the use of computerized systems in clinical investigations. | ||
| Development of FDA-Regulated Medical Products | Elaine Whitmore, ASQ Quality Press | 05/02/2007 |
| This is an excerpt from Elaine Whitmore's book, Development of FDA-Regulated Medical Products. Chapter One discusses the changing face of healthcare in the United States. The book in its entirety includes a review of the significant changes within the FDA that affect the requirements and review of medical products; updated facts and figures; expansion of subjects that have grown more critical, such as clinical outcomes, human factors, and marketing objectives; and additional new topics such as the role of product development in hazard analysis, recalls, and product liability. | ||
| Benefits of Adopting Rapid Microbial Methods | Celsis | 01/23/2007 |
| It's no secret that Rapid Microbial Methods (RMM) can save pharmaceutical manufacturers time and money, yet widespread adoption of these technologies remains slow due to perceived regulatory hurdles. | ||
| 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. | ||
| From Procedural to Risk-Based Compliance and Enforcement | John Blanchard, ARC Advisory Group | 10/30/2006 |
| In this presentation, ARC analyst John Blanchard outlines the steps required for moving from the old to the new model, and what they mean for pharmaceutical manufacturers and the FDA. | ||
| 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. | ||
| Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in Producing Viral Vaccines | FDA Center for Biologics Evaluation and Research | 10/09/2006 |
| The U.S. Food and Drug Administration (FDA) on Sept. 28, 2006 issued new guidance to aid manufacturers in developing safe and effective cell-based viral vaccines. The updated guidance conveys information for determining the suitability of a cell culture for manufacturing, as well as testing and validating the safety and purity of the cells used in the development and production of viral vaccines. | ||
| Kick–Starting PAT to Achieve Quality by Design in cGMP Bioprocessing | TechniKrom, Inc. | 10/02/2006 |
| Since 2002, the FDA has promoted a continuous, process-centric approach to validation vs. the prior product–centric one. Yet, many pharma and biopharma companies have failed to incorporate that approach into their strategic plan. This white paper explains the new distinctions and what they mean in practice, then identifies PAT opportunities that can be implemented immediately to support QBD activities. | ||
| FDA's Guidance on Effective Quality Risk Management | 08/25/2006 | |
| FDA's guidance on effective quality risk management approach can ensure high quality of the drug product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing of pharmaceutical products. | ||
| [Report on] the Food and Drug Administration’s National Drug Code Directory | U.S. Dept. of Health & Human Services' Office of Inspector General | 08/15/2006 |
| HHS’ Office of Inspector General found that the Directory is incomplete (with an estimated 9,187 prescription drug products missing) and inaccurate, (with an estimated 34,257 drug products no longer on the market or listed in error). The Office’s report also concluded that FDA’s drug product listing process and lack of oversight contribute to deficiencies in the Directory. | ||
| IT and Data Security: Deloitte Assesses Pharma's Readiness | Deloitte Life Sciences & Health Care | 06/08/2006 |
| Deloitte Touche Tohmatsu (DTT) surveyed a global representation of leading life sciences executives to determine the security issues facing the industry. The resulting study presents industry trends, security considerations that go beyond the realm of IT, and issues such as business continuity management, privacy and the management of cross-border data. | ||
| Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process | U.S. Government Accountability Office | 04/24/2006 |
| In 2004, several high-profile drug safety cases raised concerns about the FDA's ability to manage postmarket drug safety issues. In some cases there have been disagreements within FDA about how to address safety issues. In this report GAO (1) describes FDA’s organizational structure and process for postmarket drug safety decision making, (2) assesses the effectiveness of FDA’s postmarket drug safety decision-making process, and (3) assesses the steps FDA is taking to improve postmarket drug safety decision making. | ||
| Process Modeling and Control Challenges in the Pharmaceutical Industry | Phil Dell'Orco, GlaxoSmithKline | 02/24/2006 |
| In this 2003 presentation made at a conference held by the University of Texas, Phil Dell'Orco, GSK's Leader for Process Safety and Design, summarized the challenges facing engineers as they work to improve control of pharmaceutical processes in an industry still dominated by chemists. | ||
| U.S.A. GMPs: What Offshore API Manufacturers Need to Know | Nicholas Buhay, Deputy Director of Manufacturing and Product Quality, FDA's CDER | 02/20/2006 |
| This 341-page PDF outlines a course that Mr. Buhay gave in Beijing last year, summarizing what any manufacturer outside the U.S. should know about GMPs and FDA regulations. | ||
| Overview of the Environmental Impact of Pharma Operations on Water Systems | Emerging Contaminants Workgroup | 02/20/2006 |
| This White Paper was prepared to initiate dialogue on pharmaceutical waste disposal to municipal sewer systems. The first three pages discuss local issues, but the rest provide a broad discussion, facts and figures. | ||
| Innovative Drug Development in the Context of FDA Regulation | John E. Calfee, American Enterprise Institute | 02/17/2006 |
| The author describes what the pharmaceutical industry and FDA need to do to escape the current crisis of public confidence. | ||
| A Profile of the Pharmaceutical Manufacturing Industry | U.S. Environmental Protection Agency | 01/20/2006 |
| Aiming to develop integrated environmental policies that address the inter-relationships among pollutant releases to air, water and land, in the late 1990s EPA adopted a whole-facility focus. Recognition of the need to develop an industrial “sector-based” approach within the EPA Office of Compliance led to the creation of this document. | ||
| Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP | U.S. Food and Drug Administration | 01/19/2006 |
| This document (Final Guidance, issued January 2006) is intended to provide guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) requirements. | ||
| 21 CFR 11: Risks of Noncompliance | Master Control | 08/24/2005 |
| This paper addresses major concerns about interpretation of the regulation and the ensuing release of "Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application" in August 2003. It also explains FDA's clarification of two points: (1) FDA intends to interpret Part 11 narrowly; and (2) the agency is taking a risk-based approach in enforcing compliance to some of the technical controls for Part 11, such as validation, audit trails, record retention and record copying. | ||
| CDER's 2004 Report to the Nation: Improving Public Health Through Human Drugs | FDA's Center for Drug Evaluation and Research | 08/23/2005 |
| This 66-page report discusses what was accomplished by FDA's Center for Drug Evaluation and Research in 2004, and looks at the initiatives it will be tackling this year and in the near future. | ||
| Applications Note on Multipurpose Peeler Centrifuges | Riera Nadeu U.S.A. | 04/29/2005 |
| The latest generation of multipurpose GMP-compliant peeler centrifuges have been designed to ease batch changes, prevent contamination, and improve separation. This applications note from Riera Nadeu U.S.A. discusses considerations for specifying, cleaning and using this type of equipment. | ||
| Handling MSDSs and Global Hazard Communications | Marshall Denhoff, American Industrial Hygienists Assn. | 04/29/2005 |
| Do you know all you need to know about global hazard communications and material safety data sheets? Marshall Denhoff of the American Industrial Hygienists Association shares best practices in this article. | ||
| Total Chemicals Management: Follow the Money and Save | Mark Wysong, American Industrial Hygienists Association | 04/29/2005 |
| EH&S managers in the pharmaceutical industries may often overlook chemicals management. Taking a "total management" approach can improve compliance and lead to savings, says the American Industrial Hygienists Association's (AIHA) Mark Wysong. | ||
| Software-Based Validation of Processing Systems Following 21 CFR 11 | Siemens | 04/29/2005 |
| This technical applications article discusses the implications of 21 CFR Part 11 and how Siemens Simatic HMI can be used to facilitate validation. | ||
| FDA Guidance: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment | U.S. Food and Drug Administration | 03/26/2005 |
| This document provides guidance to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment, specifically on (1) safety signal identification, (2) pharmacoepidemiologic assessment and safety signal interpretation, and (3) pharmacovigilance plan development. | ||
| Influenza Vaccine: Current Status, Lessons Learned and Preparing for the Future | U.S. Food and Drug Administration | 02/18/2005 |
| Dr. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, testified Feb. 10, 2005, before the U.S. House of Representatives' Committee on Government Reform, regarding the present and future status of flu vaccine supply and demand. Access the 6-page transcript here. | ||
| Qualifying a NIR Spectrometer to Meet 21 CFR Part 11 | Frederick H. Long, principal, Spectroscopic Solutions | 01/26/2005 |
| Clear goals and an early FAT prevented scope creep when at at-line NIR system needed to be validated for coating a pharmaceutical patch. Frederick H. Long, principal of Spectroscopic Solutions, outlines the secrets to this project's success in this 4-page PDF. | ||
| PAT Answers: FDA's Final Guidance | U.S. Food and Drug Administration | 10/14/2004 |
| FDA recently released its final guidance on process analytical technology, “PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance," as part of its broader 21st Century cGMP initiative. | ||
| FDA Goes "Final" with Its 21st Century cGMP Guidance | FDA | 10/13/2004 |
| FDA's final report on “Pharmaceutical cGMPs for the 21st Century—a Risk-Based Approach” is hot off the press. From aseptic processing to electronic record-keeping to quality systems, get your guidance here. | ||
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