Compliance Center
Welcome to Quality Solutions’ Compliance Center. The location for informational presentations on a range of topics related to USP<797> and <800> compliance.
Presentation 1
USP<797>/<800> Sterile Compounding:
Overview & Trends Prior to Revision Implementation
View Presentation
Presentation 2
USP<797>/<800> Sterile Compounding:
Key Elements of a Compliant Environmental Sampling Plan
View Presentation
Presentation 3
USP<797>/<800> Sterile Compounding:
Common Design Pitfalls in USP<797>/<800>
View Presentation
Presentation 4
USP<797>/<800> Sterile Compounding:
Identifying Resources to Support Your Compliance Efforts
View Presentation
Global Standards and Guidelines
- • European Committee For Standardization (CEN)
- • European Medicines Agency
- • International Conference on Harmonisation (ICH)
- • International Organization for Standardization (ISO)
- • Medicines and Healthcare products Regulatory Agency (MHRA): (UK MCA)
- • Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme- jointly referred to as PIC/S
- • SAIGlobal.com (a comprehensive site to purchase some standards)
Professional and Industry Organizations
- • American Association of Pharmaceutical Scientists (AAPS)
- • American Association of Tissue Banks
- • American Society of Health-System Pharmacists
- • American Society of Mechanical Engineers (ASME)
- • American Society for Quality (ASQ) Biomedical Division
- • Biotechnology Industry Organization (BIO)
- • Consumer Healthcare Products Association (CHPA)
- • Generic Pharmaceutical Association (GPhA)
- • International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS)
- • International Pharmaceutical Excipients Council of the Americas (IPEC-Americas)
- • International Society for Pharmaceutical Engineering (ISPE)
- • ISBER International Society for Biological and Environmental Repositories
- • PDA: An International Association for Pharmaceutical Science and Technology
- • Pharmaceutical Research and Manufacturers of America (PhRMA)
- • Regulatory Affairs Professional Society
U.S. Government Agencies
- • 21 CFR Part 11
- • American National Standards Institute
- • ASHP
- • CDER - Drugs Division
- • CBER - Biologics
- • Centers for Disease Control and Prevention
- • FDA
- • FDA Inspection Guides
- • FDA-Medical Device Quality Systems Manual
- • Federal Register
- • Most Recent Warning Letters
News Sources
- • BioSpace, Inc.
- • Cal Lab Magazine
- • FDA News.com
- • Health/Medical Internet Search Engine
- • Pharmaceutical Online
- • Quality Magazine