Professionals in the Life Science industry must keep themselves up-to-date with ever changing regulations, guidelines, good-practice guides and inspection and enforcement practices. We've assembled a few information resources, as combing through the internet can be time consuming to find the right information when needed.

ISPE:  International Society of Pharmaceutical Engineers
A global, not-for-profit membership organization that provides education, training, and technical publications to Life Science professionals.  Committed to the advancement of the educational and technical efficiency of its members through forums for the exchange of ideas and practical experience.  Developer of GAMP (Good Automated Manufacturing Practices).

PDA:  Parenteral Drug Association
Advances pharmaceutical and biopharmaceutical technology internationally by promoting scientifically sound and practical technical information and education for industry and regulatory agencies.  Publishes PDA Letter and PDA Journal.

PharmWeb - PharmWeb Discussion Forum
A PDA sponsored online forum that serves as a platform for exchanging practical, and sometimes theoretical, ideas within the context of some of the most challenging issues confronting the pharmaceutical industry.  

International Confederation of Contamination Control Societies (ICCCS)
Coordinates international exchange of contamination control knowledge; coordinates and promotes international contamination control standardization; helps the elimination of technical barriers to trade.

R3Nordic
Nordic Association for Contamination Control and Clean Rooms (Sweden, Denmark, Norway and Finland).  Interests encompass contamination control and other systems targeted at achieving low levels of contamination and high levels of performance assurance for the protection of personnel and products, and including issues relating to maintenance of systems and operating procedures. 

American Association of Pharmaceutical Scientists
A professional, scientific society of more than 10,000 members employed in academia, industry, government and other research institutes worldwide. Aims to advance science through the open exchange of scientific knowledge, serve as an information resource, and contribute to human health through pharmaceutical research and development.

Biotechnology Industry Organization (BIO)
Biotechnology information, advocacy and business support.

Drug Information Association (DIA)
A neutral, global forum, completely independent from the influence of any one organization or authority, in which you can learn about advances, issues, regulations, and trends from the perspective of healthcare companies, academic institutions, and governmental regulatory agencies alike.

International Federation of Pharmaceutical Manufacturers Association (IFPMA)
A non-profit, non-governmental Organization (NGO) representing, through our member associations, the worldwide research-based pharmaceutical industry and manufacturers of prescribed medicines.  Three primary tasks: Develop global position statements on matters of health care policy. Encourage the global exchange of information within our industry. Work closely with international organizations dedicated to health and trade-related issues.

Institute of Validation Technology (IVT)
Dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries through educational publications, timely conferences, and other informational products.

International Pharmaceutical Excipients Council (IPEC)
Works on excipient safety and public health issues, in connection with international trade matters, and to achieve harmonization of regulatory standards and pharmacopoeial monographs.

Pharmaceutical Research and Manufacturers of America (PhRMA)
Represents the country's leading research-based pharmaceutical and biotechnology companies.  Conducts advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical/biotechnology research companies.

The Parenteral Society
Information concerning all aspects of parenteral technology and parenteral administration.  Education and training of personnel in the fields of parenteral technology and administration.

Biopharm International
BioPharm provides a peer-reviewed forum for its readers to exchange practical, hands-on information for developing and manufacturing pharmaceutical products through biotechnology; and it provides a supportive, authoritative voice in the evolving business, regulatory, scientific, and technical areas of the biopharmaceutical industry.

Cleanroom Technology
Magazine for the cleanroom industry.

Dickinson's FDA Webview
Interactive Web site that watches the U.S. Food and Drug Administration all day long. From the leading publisher of FDA-content business newsletters since 1984, you can monitor regulatory, legal, policy and scientific news affecting all FDA-regulated healthcare products and their marketing activities.  Also has links to its print newsletters.

fdainfo.com
How to find FDA documents and other regulatory news and information.  Links and info for several newsletters and reports.

FDA News.com
Exclusive news and analysis on drugs, medical devices and biologics.

foi online
Freedom of Information documents available on-line, anonymously. 

Key2Compliance:  
Compliance seminars and conferences.

Micro-Virology Laboratories, Inc.
Environmental monitoring, microbiology and virology biosafety testing and consulting services.

Pharmaceutical Engineering
Feature articles provide practical application and specification information on the design, construction, supervision, and maintenance of process equipment, plant systems, instrumentation, and facilities.

Pharmaceutical Online:  
Links to products and suppliers, relevant content and industry news. Serves the needs of pharmaceutical professionals working on pharmaceutical scale-up, pharmaceutical contract manufacturing, pharmaceutical clinical trials, production, processing, manufacturing, engineering, and related regulatory and policy issues.

Pharmaceutical Technology

PharmaNet, Inc.:  
Compliance seminars and conferences.

The Gold Sheet:  
Designed for manufacturing and quality control managers concerned with quality control procedures and FDA regulatory and enforcement activities in the pharmaceutical and biological industries. The publication covers developments in FDA regulations and policies governing the manufacture and processing of healthcare products and state-of-the-art production and quality techniques.

The document files below are in Adobe Portable Document Format (.pdf).

Selected Regulations

21 CFR Part 11Electronic Records, Electronic Signatures

21 CFR Part 58—Good Laboratory Practice for Nonclinical Laboratory Studies (GLPs)

21 CFR Part 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs, General GMPs)

21 CFR Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMPs)

21 CFR Part 310—New Drugs

21 CFR Part 312—Investigational New Drug Application (IND)

21 CFR Part 314—Applications for FDA Approval to Market a New Drug (NDA)

21 CFR Part 600—Biological Products, General

21 CFR Part 610—General Biological Products Standards

21 CFR Part 803—Medical Device Reporting

21 CFR Part 809—In Vitro Diagnostic Products for Human Use

21 CFR Part 812—Investigational Device Exemptions (IDE)

21 CFR Part 814—Premarket Approval of Medical Devices (PMA)

21 CFR Part 820—Quality System Regulation (QSR)

21 CFR Part 860—Medical Device Classification Procedures

21 CFR Part 1271—Human Cells, Tissues, and Cellular and Tissue-Based Products

42 CFR Part 493—Laboratory Requirements(Clinical Laboratory Improvement Amendments of 1988 - CLIA)

California Sherman Food, Drug and Cosmetic Laws

Selected Guidance Documents

CBER/CDER Guidance: INDs—Approaches to Complying with CGMP During Phase 1 (2006)

CDER Guidance: Exploratory IND Studies(2006)

CBER Guidance: Content and Review of Chemistry, Manufacturing, and Control(CMC) Information for Human Gene Therapy Investigational New Drug Applications(2004)

CBER/CDER Guidance: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (2006)

CBER/CDER Guidance: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (2004)

General Principles of Software Validation (2002)

ICH/FDA Guidance: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (2001)

CBER Guidance: Cooperative Manufacturing Arrangements for Licensed Biologics (1999)

ORA/CDRH Guidance: Guide to Inspections of Quality Systems (1999)

ICH/FDA Guidance: E6 Good Clinical Practice:  Consolidated Guidance (1996)

CBER/CBER Guidance: Guidance on General Principles of Process Validation (1987)

Website Links

FDA Home Page

CBER Home Page

CDER Home Page

CDRH Home Page

FDA/ORA (Office of Regulatory Affairs - FDA Field Operations)

FDA Search Page

CLIA - Clinical Laboratory Improvement Amendments

CDC Home Page

NIH - rDNA and Gene Transfer

NIST-National Institute of Standards and Technology

The Code of Federal Regulations

Federal Register

FDB (California Food and Drug Branch)

Foreign Regulatory Agencies and other Regulatory Websites

Health Canada-Health Products and Food Branch

EMEA (EU Regulatory Body)

EU cGMPs

Japan Ministry of Health, Labor and Welfare

ICH Home Page

WHO/OMS: World Health Organization

Commercial/Professional Websites

21 CFR Part 11 Compliance Website

AABB - American Association of Blood Banks

ATCC (American Type Culture Collection)

BioPharm International

FACT (The Foundation for the Accreditation of Cell Therapy)

FOI Services (Source for FDA Inspection Results)

IBC USA Conferences Inc.

IEST (Institute of Environmental Sciences and Technology)

ISCT (International Society for Cellular Therapy)

ISO (International Organization for Standardization)

ISPE (International Society for Pharmaceutical Engineering)

Netcord-FACT

PDA (Parenteral Drug Association)

U.S. Pharmacopeia