Introduction : Risk managementprinciples are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. Quality risk management is used in the pharmaceutical industries and it is becoming evident that quality risk management is a valuable component of an effective quality system. … Continue reading Quality Risk Management ICH Q9 →

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Below given are some questions and answers related to change control in Pharmaceutical so pl go through it and provide your comments. Hey, "Rivela D" is running a great offer. Shop Now: https://bitlii.cc/OP/b20lxymzzrpHey, "Udemy D" is running a great offer. Shop Now: https://bitlii.cc/OP/b20lxzgv9ymHey, "SBI Card D" is running a great offer. Shop Now: https://bitlii.cc/OP/b20lxyxw3dwHey, "Indusind … Continue reading Change Control Related Questions and Answers →

OBJECTIVE To lay down a procedure for receipt, investigation, review and response of market complaints 2.         RESPONSIBILITY In charge / Designee – Quality Assurance shall be responsibleFor handling market complaintsMaintaining relevant documents and market complaint register.Keeping the procedure current and applicableIn charge– Quality Control and In charge - ProductionAssist in investigation of the market complaintIn … Continue reading Handling of Market complaints →

Bellow are the Risk assessment report at different stages like dispensing, sifting, milling, wet granulation, drying, blending, compression and coating of tablet manufacturing process. The below risk is identified based on risk involved in the process but not limited to .

Function of camera in Blister Packing Machine : The Color Camera System is to be attached on to the blister packing machine.  It is designed to detect and reject the defective blisters during blistering of the product. It can inspect tablets or capsules (hard or soft gelatin) blistered in following types of material of construction … Continue reading Performance Qualification of Colour Camera System for Blister Packing Machine →

OBJECTIVE : To describe the procedure for cleaning of Octagonal Blender 2.0       RESPONSIBILITY: 2.1     Technical Assistant –Production shall be responsible to perform the cleaning of Octagonal Blender. 2.2 Executive-Production shall be responsible to ensure the cleaning of Octagonal Blender as per SOP 3.0         PROCEDURE:    3.1    TYPE “A” CLEANING  (Batch to Batch Cleaning): Ensure that … Continue reading Procedure for cleaning of Octagonal Blender →

1.         OBJECTIVE  1.1      To lay down a procedure for indent, receipt, usage and specifications of Fluid Bed Drier Filter Bag. 2.         RESPONSIBILITY Technical assistant - To follow the SOP. Executive - To comply the SOP. PROCEDURE What is Fluid Bed Drier : Fluidized bed dryer (also called fluid bed dryer) is a kind of equipment … Continue reading Procedure for indent, receipt, usage and specifications of Fluid Bed Drier Filter Bag →