SOP for operation of rapid mixer granulator (RMG) with cone mill in Pharma Industry Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of rapid mixer granulator with cone mill in Pharma Industry Scope This SOP is applicable for operation of rapid mixer granulator with cone mill to the formulation plant of Pharma … Read more
Cleaning of Rapid Mixer Granulator with Cone Mill in Pharma Industry Standard Operating Procedure (SOP) Objective: To lay down a procedure for cleaning of Rapid Mixer Granulator with cone mill in Pharma Industry. Scope: This SOP is applicable for the cleaning of Rapid Mixer Granulator with cone mill located in oral section at formulation plant … Read more
SOP on cleaning of Paste Kettle in Pharma Industry Standard Operating Procedure (SOP) Objective To lay down a procedure for cleaning of Paste Kettle in Pharma Industry. Scope This SOP is applicable for the cleaning of Paste Kettle in the formulation plant of Pharma Industry. Responsibility Production Operator/ Technician – For cleaning of the equipment. … Read more
SOP for operation of Metal Detector in Pharma Industry Standard Operating Procedure (SOP) Objective: To lay down a procedure for operation of metal detector in Pharma Industry. Scope: This SOP is applicable for the operation of metal detector to the formulation plant of Pharma Industry. Responsibility: Production Operator/ Technician shall be responsible for operation of the … Read more
SOP on operation of Paste Kettle In Pharma Industry Standard Operating Procedure (SOP) Objective To lay down the procedure for operation of Paste Kettle In Pharma Industry. Scope This SOP is applicable for operation of Paste Kettle In Pharma Industry. Responsibility Production Operator/ Technician – For operation of the equipment. Production Officer/ Executive – For … Read more
Contract production, analysis, and other activities in Pharma Industry Principle. Contract production, analysis and any other activity covered by GMP must be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a product, or work or analysis, of unsatisfactory quality. All arrangements for contract production and analysis, including technology transfer … Read more
Pharma Manufacturing Premises – Risk classification guide for drug good manufacturing practices observations Risk 1 (critical) observations in Pharma Industry There was no air filtration system to eliminate airborne contaminants likely to be generated during fabrication or packaging. There was generalized malfunctioning of the ventilation system(s), with evidence of widespread cross-contamination. Segregation of manufacturing or … Read more
Process Validation: General Principles (USFDA) in Pharma Industry This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes. FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle. The lifecycle concept links product and process development, qualification … Read more
Indian Pharmacopoeia Commission (IPC) In the healthcare system, Indian Pharmacopoeia Commission (IPC) plays an important role particularly in matters related to the quality standards, safety and rational use of medicines in the country. IPC was set up on 01st January, 2009 as an autonomous Institution under the Ministry of Health and Family Welfare (MoHFW), Government … Read more
SOP for Procedure of shutdown and startup of Facility Objective To lay down the procedure of shutdown and start-up after shutdown of Facility. Scope This SOP is applicable for procedure of shutdown and start up after shutdown of Facility in the formulation plant. Responsibility All personnel working in respective areas. Accountability Head of all respective … Read more