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Quality Assurance is a vital part of drug development in the small pharmaceutical environment. It is the department which is responsible for ensuring that all the appropriate procedures have been followed and documented so that clinical progress can be made.
Online Journals
- The quality asssurance journal
- The quality asssurance journal for pharmaceutical professionals
Quality Assurance Device Manufacturers
- Dickson
- Innovative solutions in recording and monitoring instruments for applications involving critical storage, human comfort, laboratory environments, and process control.
- DeltaTrak
- DeltaTRAK specializes in a range of monitoring, recording and indicating instruments, especially their In-Transit Temperature Recorder used in shipping pharmaceuticals for Quality Assurance, Validation and Regulatory Compliance
- Orion ThermaSenseTM
- The ThermaSense monitor is a temperature data-logger that is designed using the latest microprocessor technology to track changes in Temperature and Humidity over time. Excellent for shipping pharmaceuticals for Quality Assurance, Validation and Regulatory Compliance
Pharmaceutical Quality Assurance Resources
- Home Pharmaceutical Industry Resources Drug Development Outsourcing Contract GMP Synthesis Contract GMP Drug Manufacturers Contract GMP Analytical Sevices Medicinal Chemistry Pharmaceutical Consultants
- FDA Home PAGE
- Homepage of the FDA
- FDA Guidance Page
- Guidance documents represent the Agency's current thinking on a particular
- FDA Warning Page
- Warning letters sent to pharmaceutical companies from the DDMAC
- The National Center for Complementary and Alternative Medicine (NCCAM
- Other Databses
- The Code of Federal Regulations
- Code of federal regulations
- FDA Watch
- Information on recent FDA decisions
- Drug GMPs Issued By The U.S. FDA
- Just when you thought you knew the drug cGMP regulations (CFR 210 & 211), they're going to be changed !
- Electronic filing
- ITM associates assist companies in electronic filing for the FDA
- Investigational New Drugs (IND) and Drug Development
- This site is designed to be a guide to the latest sites on investigational and newly approved drugs
- The United States Pharmacopeia and the National Formulary
- USP establishes standards for drugs and their dosage forms, excipients, nutritional supplements, botanical preparations, and medical devices.
- European Public Assessment Report
- When a pan-European marketing authorisation is granted, the EMEA will systematically make available a European Public Assessment Report (EPAR), giving the reasons for the CPMP's opinion.
- Orange County Regulatory Affairs Discussion Group
- Web Page provides information concerning the activities of OCRA. This is the gateway to Southern California and the Southwest's premier Website for FDA regulated industries
- Regsource
- Organizing worldwide Regulatory, Clinical, Toxicological, CMC and other drug/device development-related information
- The National Committee for Quality Assurance
- NCQA Homepage
- Quality Assurance Compliance Procedures for Pharmaceutical and Biotechnology Manufacturers
- fully proven, practical system of SOPs, documentation, and associated forms that can create the basis for your own assurance/documentation system.
- The Regulatory Affairs Professionals Society
- RAPS has been a leader in establishing and supporting the regulatory affairs profession, which plays a critical role in healthcare.
- The Pharmaceutical Quality Group
- The Pharmaceutical Quality Group is a group for professional quality practitioners within the pharmaceutical industry
- Other Important Regulatory Websites
- Useful Links to Other Organizations
- Good Laboratory/Manufacturing Practice [GLP/GMP]
- Useful Links to guideline for developing analytical methods <
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Validation
- Pharmaceutical Cleaning Validation References
- Pharmaceutical Cleaning validation method references for Alconox, Inc. detergents
- Biometics cGMP/Regulatory Compliance and Validation Services
- BioMetics is able to provide all validation program management services to complement the client's in house capabilities
- Validation Associates
- Specializing in providing our clients in the pharmaceutical, biotechnology, and medical device industries with Computer System Validation Project Consulting and Training Services
- Current Good Manufacturing Practices 820.60
- The purpose of section FDA GMP 820.60/61 is to ensure that all
- products, including manufacturing materials used in the
- manufacture of a finished device, are properly identified as to
- their current status, for example, whether they are accepted,
- rejected, or reworked.
- products, including manufacturing materials used in the
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GMP Training Links
- GMP for Vendors
- GMP Vendor training course
- GMP Awareness group
- GMP training course
- The GMP Institute
- GMP Training and Auditing
- GMP Topics
- In-depth look at particular areas of interest to the drug and device industry
- GMP TRENDS
- GMP TRENDS?is a unique and objective INFORMATION - DISSEMINATION LETTER published specifically for the PHARMACEUTICAL, MEDICAL DEVICE and related industries
- FD483
- EDITED EXCERPTS FROM ACTUAL 483 OBSERVATION REPORTS BY FOOD AND DRUG ADMINISTRATION INVESTIGATORS
- Pharmaceutical Manufacturing GMP Awareness Overview
- Training and Communications Group, Inc. has developed a series of GMP Awareness Training Programs.
- Pharmaceutical Manufacturing Technical Skills Articles
- AMERICAN SOCIETY OF HEALTH - SYSTEM PHARMACISTS
- Pharmacists in health systems helping people make the best use of
- Pre-clinical Quality Assurance
- Coromed can provide QA services at every stage of a preclinical study, including those studies subject to Good Laboratory Practice (GLP) regulations
- Celsis
- Celsis develops and supplies rapid diagnostic and monitoring
- systems for use in the detection and measurement of low-level
- microbial contamination in a wide range of manufacturing
- processes and end products
- systems for use in the detection and measurement of low-level
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Copyright (C) 2006 by Christopher M. Marrs.