Guidelines
Navigating Bioequivalence Study Guidelines Across Global Regulatory Bodies
When conducting bioequivalence (BE) or bioavailability (BA) studies for regulatory approval, guidelines from different regulatory bodies must be adhered to. Here’s a summary of the key considerations and variations across major regulatory agencies Regulatory Guidelines Comparison USFDA Special Cases: Study Design: EMA Acceptance Range: Study Design: WHO Study Design: MHRA ... Read More
Comprehensive List of Pharmaceutical Guidelines
Self Inspection & Batch Review Risk Management Deviation Handling Change Control Out of Specification (OOS) Corrective and Preventive Action (CAPA) Process Validation Cleaning Validation Data Integrity Stability Studies GMP Pharmaceutical Quality System Pharmaceutical Development Good Storage and Distribution Practices (GSDP) Electronic documents and records Read also:
Difference Between ICH and USFDA Guidelines
ICH and USFDA guidelines are two of the most important sets of regulations for the pharmaceutical industry. Both sets of guidelines aim to ensure the safety, efficacy, and quality of pharmaceutical products. However, there are some key differences between the two sets of guidelines in terms of their scope, jurisdiction, ... Read More
References for Good Pharmacy Practice
Introduction to Good Pharmacy Practice (GPP) Patient Care and Counseling Medication Safety and Quality Assurance Pharmaceutical Supply Chain Management Ethical Considerations in Pharmacy Practice Professional Development and Continuing Education Pharmaceutical Legislation and Regulatory Compliance Information Management and Technology in Pharmacy Practice Read also: Compounding Pharmacy Violations Which Put Patients at ... Read More