EU Regulatory References

EU Regulatory References

EMA–European Medicines Agency EMA Quality Guidelines EMA Biologic Guidelines EudraLex – Volume 3 Scientific guidelines for medicinal products for human use EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines EU Regulatory System EMEA Biologics...
EU Regulatory References

Global GMPs Guidance Documents

US GMPs Background: Overview of US GMPs for Active Pharmaceutical Ingredients (API) References: Code of Federal Regulations (US GMP’s) 21 CFR 58 – Good Labratory Practices for Non-Clinical Laboratory Studies 21 CFR Parts 210 – Current Good Manufacturing...
EU Regulatory References

US Regulatory References

FDA – U.S. Food and Drug Administration Guidance, Compliance: Regulatory Information (Biologics) US BIOLOGIC REGULATIONS The final regulations published in the Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are...
EU Regulatory References

Global Process Validation Guidance

FDA Guideline On General Principles Of Process Validation WHO Supplementary Training Modules: Validation, Water, Air Handling Systems FDA’s Process Validation Guidance EMEA Process Validation ICH Q7: GMP’s for API’s PDA Technical Report #42 : Process Validation of...
EU Regulatory References

Medical Device Process Validation

Medical Device Quality Systems Manual Medical Device Process Validation Quality Management Systems – Process Validation Guidance The Global Harmonization Task Force (2004)