Reference Shortcuts
United States Pharmacopeia
Annex 1
Code of Federal Regulation
Food and Drug Administration
Association of Advancement of Medical Instrumentation
Parenteral Drug Administration
International Code of Harmonization
Pharmaceutical Inspection Co-Operation Scheme
European Commission And European Medicines Agency
International Organization of Standardization
Explore these resources to stay informed and ensure your operations are always aligned with the latest industry standards. Whether you’re ensuring regulatory compliance or seeking to implement best practices, these references are your guide to excellence in the field.
Regulatory Compliance
United States Pharmacopeia (USP)
Ensure your products meet rigorous U.S. standards for quality, purity, and strength with the definitive USP guidelines.
Code of Federal Regulations (CFR)
Access comprehensive U.S. regulations governing pharmaceuticals and biotechnology, essential for compliance and regulatory submissions.
Food and Drug Administration (FDA)
Stay informed with the FDA’s latest regulations, guidance documents, and updates to ensure your products meet safety and efficacy requirements.
Standards and Guidelines
Annex 1 – EU Guidelines on Good Manufacturing Practice (GMP)
Follow best practices for sterile manufacturing, focusing on contamination control and environmental monitoring.
International Council for Harmonisation (ICH)
Harmonize your drug development processes with global standards that ensure safety, quality, and efficacy across different regions.
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Implement globally recognized GMP inspection standards to maintain compliance with international manufacturing expectations.
Industry Resources
Association for the Advancement of Medical Instrumentation (AAMI)
Access critical standards for medical devices and healthcare technology to ensure your instruments are safe and effective.
Parenteral Drug Association (PDA)
Gain insights from PDA’s resources and events, particularly for professionals focused on parenteral drugs and microbiology.
European Commission & European Medicines Agency (EMA)
Stay compliant with regulations and guidelines for medicinal products, ensuring your operations meet the required safety and quality standards.
International Organization for Standardization (ISO)
Adopt international standards to ensure your products’ safety, reliability, and quality across various industries, including healthcare and manufacturing.