Regulatory Knowledge
The team at Phoenix Engineering Group employs their technical expertise helping companies throughout the life science industries create and manufacture life-impacting products around the world. Our professionals apply practical industry experience and logical risk-based strategies when providing design and engineering services relating to life science type facilities. The founding partners and principles have over 20 years of experience in the design and engineering of laboratories, pharmaceutical, and nutraceutical facilities. Phoenix Engineering Group has the experience needed for your project when it comes to understanding and applying Regulatory requirements to your facilities engineering and design. Those regulatory agencies, requirements, and associated organizations include:
- Current Good Manufacturing Practices (cGMP) established by the Food and Drug Administration (FDA)
- 21 CFR Part 11 – ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
- 21 CFR Part 58 – GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
- 21 CFR Part 110 – CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
- 21 CFR Part 111 – CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
- 21 CFR Part 210 & 211 – CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS AND FINISHED PHARMACEUTICALS
- 21 CFR Part 820 – CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL DEVICES
- United States Pharmacopeia (USP) Compounding Standards
- USP 795 – STANDARDS FOR COMPOUNDING – NONSTERILE PREPARATIONS
- USP 797 – STANDARDS FOR COMPOUNDING – STERILE PREPARATIONS
- USP 800 – HAZARDOUS DRUGS – HANDLING IN HEALTHCARE SETTINGS
- USP 825 – RADIOPHARMACEUTICALS – PREPARATION, COMPOUNDING, DISPENSING, AND REPACKAGING
- Drug Enforcement Administration
- Handling and Storage of Scheduled Drugs
- European Union (EU)
- World Health Organization (WHO)
- International Society of Pharmaceutical Engineering (ISPE)
- Medicines & Healthcare products Regulatory Agency for the UK (MHRA)
