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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 <

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.

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
The University of Georgia's Quality Assurance Unit
List of FDA Quaility Documents

Copyright (C) 2006 by Christopher M. Marrs.