Browse Solutions: Compliance
- White Papers/Case Studies (120)
- Analyst Reports (2)
- Webcasts (0)
- Multimedia (1)
- Application Notes (12)
- Product Information (14)
FEATURED REPORTS
WHAT'S NEW
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PAT and TOC Analysis With an Onboard Automated Standards Introduction System ...
by Hach Ultra
White paper
<P>This paper describes the use of an on-board automated sample introduction system (OASIS) that is used to run verification standards and system suitability tests in order to ensure the reliability of the TOC results. </P>
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Comparison of TOC Analyzers and Sensors for Pharmaceutical TOC Applications
by GE Analytical Instruments
Application note
In 2006, Jon S. Kauffman, PhD., Lancaster Laboratories, published results from a study on the recovery of organic compounds likely to be present in pharmaceutical water systems using on-line TOC analyzers designed for pharmaceutical use. A new study repeats the same injections, but adds the new CheckPoint TOC Sensor from GE Analytical Instruments.
REPORTS BY TOPIC
Designing a comprehensive cardiovascular safety testing regimen
By Covance Inc.
White paper
In this white paper, Covance Inc. discusses the need for a careful analysis of any medicine's impact on cardiac safety, to avoid unanticipated and hazardous effects on the heart.
Drug Safety: Improvement needed in FDA’s Postmarket decision-making and ...
By U.S. Government Accountability Office
White paper
This white paper by United States Government Accountability Office discusses the improvement needed in FDA’s postmarket decision making and oversight process.
Vaccine Safety: An FDA Perspective
By FDA Center for Biologics Evaluation and Research
White paper
This paper by the FDA CBER describes the major components of FDA’s evaluation of a biologics license application for a preventive vaccine, discuss the sources of data that FDA uses to monitor vaccine safety after licensure, and describe interactions between FDA and other governmental agencies in vaccine safety and other vaccine-related activities.
Guidance for Industry Safety Testing of Drug Metabolites
By FDA Center for Drug Evaluation and Research
White paper
This FDA CDER guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated.
Why Do you Need to be Concerned About Global Hazard Communications?
By American Industrial Hygiene Assn.
White paper
This white paper from the American Industrial Hygiene Association states that if material data safety sheets (MSDSs) are to remain a valuable tool in the protection of workers and others, all industrialized countries must work together to see that they contain the most reliable and accurate data available.
Profile of the pharmaceutical manufacturing industry
By Environmental Protection Agency
White paper
This white paper by the U.S. Environmental Protection Agency (EPA) characterizes the pharmaceutical industry, explores pollution prevention opportunities such as material substitutions, process modifications, good operating practices, recycling, recovery and reuse, and pollution prevention research in the industry, and summarizes applicable federal statutes and regulations.
Improving Public Health Through Human Drugs
By FDA Center for Drug Evaluation and Research
White paper
This 2004 report from the FDA's Center for Drug Evaluation and Research (CDER) discusses how to develop new medicines efficiently without compromising safety and effectiveness, and identifying and managing issues related to the safe use of approved medicines.
Improve processes through designed experimentation
By InSite Technologies Inc.
White paper
This white paper from InSite Technologies Inc. describes how one medical device manufacturer attained significant improvement in advancing its process understanding without having to revalidate. The company did this using designed experimentation.
Tracking and controlling employee training records and requirements in FDA ...
By MasterControl Inc.
White paper
This white paper from MasterControl identifies the basis for employee training requirements and examines the challenges to meet them, the shortcomings that lead to general system failures, and a new approach for meeting and going beyond tracking requirements.
Improving employee performance and compliance in the life science industries
By Blue Mountain Quality Resources Inc.
White paper
This white paper by Blue Mountain Quality Resources Inc. discusses the importance of employee performance and training, including in areas such as regulatory asset management.
Compliance challenges with enterprise application integration
By Clarkston Consulting
White paper
This white paper by Clarkston Consulting describes challenges faced by life sciences companies to meet 21 CFR Part 11 regulations with respect to enterprise application integration.
Optimizing asset management to comply with 21 CFR Part 11 requirements
By Infor
Case study
In this case study, Infor helps a leading pharmaceutical company optimize asset management in compliance with FDA's 21 CFR Part 11 requirements.
The future of European drug development: An expert's view
By Fulcrum Pharma Developments
White paper
European drug development is more globally minded than any other region of the world. This white paper by Fulcrum Pharma Developments Ltd. features an interview with Frank Fildes, former senior vice president and head of global development for AstraZeneca Worldwide.
Life sciences and biotechnology: A strategy for Europe
By European Commission
White paper
This 2002 white paper by the Commission of the European Communities (now the European Commission) proposes a framework to find ways forward on policy governing the life sciences and biotechnology industries in Europe.
EU Clinical Trials Directive: Effects on clinical research
By Fulcrum Pharma Developments
White paper
Fulcrum Pharma Developments Inc. outlines the main objectives of the European Union (EU) Clinical Trials Directive and reviews how to respond so that clinical trials can be performed in the most cost-and time-effective manner.
Methods Development and Validation
By Azopharma Inc.
Product collateral
Azopharma develops analytical methods for potency, dissolution, impurities, moisture, metals, residual solvents, and physical-chemical tests. After successful method development, Azopharma Services can validate your analytical method per ICH guidelines.
Reducing the toxicity of residual solvents used in drug manufacturing
By Teledyne Tekmar
Application note
This application note from Teledyne Tekmar discusses the use of a gas chromatograph/mass spectrometer (GC/MS) and a headspace analyzer to provide a routine method for analyzing residual solvents from drug manufacturing processes.
FDA Guidance for Industry: E15 Definitions for Genomic Biomarkers, ...
By FDA Center for Drug Evaluation and Research
White paper
This guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories.
Best practices in international logistics
By Aberdeen Group
White paper
After researching companies that are transforming their international logistics operations, Aberdeen Group selected eight companies as best practice winners and, based on their successes, offers recommendations for other companies that want to improve their international logistics performance.
Combination products: Navigating two FDA quality systems
By Microtest Laboratories
White paper
While combination products are experiencing dramatic growth, the convergence of drugs/biologics and devices brings a host of regulatory challenges. This paper addresses the critical issues in this process, including defining the FDA’s regulatory framework, reviewing new developments in FDA thinking, and developing effective quality assurance systems.
MET ONE 3400 Series Portable Airborne Particle Counters
By Hach Ultra
Product collateral
MET ONE 3400 Series airborne particle counters offer faster sampling and simple portability for ease of use and reduced technician time. Dual hot-swappable batteries minimize downtime and, thanks to its Long Life Laser technology, the 3400 performs reliably, promoting low-cost, long-term ownership.
ANATEL A643a Total Organic Carbon (TOC) Analyzer
By Hach Ultra
Product collateral
The ANATEL A643a offers reliable, robust performance in water system-critical TOC monitoring and is fully compliant with pharmaceutical industry methods, such as USP<643> and <645>, EP 2.2.44 and JP XV<60>.
Industry-specific OLAP: The coming wave of data analysis
By DataLoom Solutions
White paper
DataLoom Solutions discusses the advancements in data management technology and how Industry-Specific OLAP (ISO) overcomes the limitations of datawarehousing technology.
Cleanroom requirements, certification and monitoring
By Lighthouse Worldwide Solutions
Application note
In this application note, Lighthouse Worldwide Solutions explains the monitoring of a cleanroom to meet ISO standards and to establish compliance.
Particle monitoring in pharmaceutical cleanrooms
By Lighthouse Worldwide Solutions
Application note
In this application note, Lighthouse Worldwide Solutions describes cleanroom standards, FDA and EU guidelines and how particle monitoring in cleanrooms benefits regulatory and quality control in the production of pharmaceuticals.
