The issue of pharmaceutical data integrity is more important than it has ever been. Data is both the backbone of CGMP compliance and the fuel of the digital economy. Secondly, global regulatory bodies have become increasingly focused on data integrity and have issued...
The following is a collection of resources that will be fascinating to those interested in what is happening within the work of using adeno-associated viruses (AAV) to develop drugs that manipulate genes for desirable clinical outcomes. The resources listed below are...
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...
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...
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...
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...
