GMP Deviation in Pharma industry: Causes, Types, and Solutions
Read Now Full Article Here
Types of GMP Deviation
GMP Deviation can be categorized into several types, depending on their severity and potential impact. Understanding these types is crucial for determining the appropriate response and ensuring regulatory compliance:
Critical Deviations
Critical deviations are the most severe type. They directly impact product quality, patient safety, or regulatory compliance. Immediate corrective action is required to prevent harmful outcomes.
Major Deviations
Major deviations have a significant impact on product quality but may not pose an immediate risk to patient safety. Nonetheless, they must be addressed promptly to prevent future problems.
Minor Deviations
Minor deviations have minimal or no impact on product quality or regulatory compliance. These deviations are often routine and can be resolved through standard operating procedures.
Planned Deviations
Planned deviations occur intentionally, with prior approval, to address temporary changes in the process or materials used. They must be justified, documented, and aligned with regulatory standards.
Read Now Full Article Here
Owner, Hamfekr Sanaat Anahita Co.
5 个月IPC Lead,Certified Lead Auditor ISO 9001, Quality trainer
5 个月I think planned deviation is canceld
Pharmaceutical Chemist| Registered Pharmacist| Assistant Professor at Punyashlok Ahilyadevi Holkar Solapur University, Solapur.
5 个月Insightful
Senior Manager @ Pharmaceuticals professional, Analytical Methods development/validation expert
5 个月Insightful
Very informative