Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
Neologic Engineers, Clean-in-place (CIP) is an automated method of cleaning the interior surfaces of pipes, tanks, lines, process equipment.(CIP) Systems Reduce Cleaning Time and Costs. CIP Controls of all important parameters like time, temperature, flow, concentration.
Process validation is a requirement of the current Good Manufacturing Practices (cGMP) Regulations for Finished Pharmaceuticals. Validation is defined as a documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.
Almost all the regulatory bodies are expected to have Risk Based Quality System. Quality Risk and its assessment has tremendous output and benefits towards the Patient Safety.
Neologic Engineers, Clean-in-place (CIP) is an automated method of cleaning the interior surfaces of pipes, tanks, lines, process equipment.(CIP) Systems Reduce Cleaning Time and Costs. CIP Controls of all important parameters like time, temperature, flow, concentration.
Process validation is a requirement of the current Good Manufacturing Practices (cGMP) Regulations for Finished Pharmaceuticals. Validation is defined as a documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.
Almost all the regulatory bodies are expected to have Risk Based Quality System. Quality Risk and its assessment has tremendous output and benefits towards the Patient Safety.