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Quality Assurance is the department which is responsible for ensuring
that all the appropriate procedures have been followed and documented.
Online Journals
Quality Assurance Device Manufacturers
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
- Investigational New Drug (IND) Information
- Information from the Food and Drug Administration (FDA) on submitting a Sponsor-Investigator Investigational New Drug (IND) application for a biological product
- The Code of Federal Regulations
- Code of federal regulations
- FDA Watch
- Information on recent FDA decisions
- 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.
- 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
- The Regulatory Affairs Information Home Page
- Your Internet Resource for "things regulatory"
- The Pharmaceutical Quality Group
- The Pharmaceutical Quality Group is a group for professional quality practitioners within the pharmaceutical industry
- Worldwide Regulatory Document Solutions
- Xerox Pharmaceutical Industry Business Unit focuses on streamlining the process forworldwide management of regulatory submissions
- Other Important Regulatory Websites
- Useful Links to Other Organizations
- Good Laboratory/Manufacturing Practice [GLP/GMP]
- Useful Links to guideline for developing analytical methods
- International Conference on Harmonisation
- The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
SOP's
- PharmComm Standard Operating Procedures (SOP) Index
- PharmComm provides Computer System Validation (CSV) services, Document Imaging, and Standard Operating Procedures (SOPs) to the pharmaceutical, biotechnology, and medical device industries
- IAGIM Standard Operating Procedures (SOP) list
- The International Association of Generic and Innovative Drug Manufacturers offers SOP's and Protocols on a PAY-AS-YOU-USE� basis
Validation
- Pharma Systems Validation
- Pharma Systems is able to offer a GMP design review service
- Pharmaceutical Cleaning Validation References
- Pharmaceutical Cleaning validation method references for Alconox, Inc. detergents
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
