Equipment Name: TUNNEL STERILIZER DEPARTMENT PRODUCTION NAME OF THE SUPPLIER MODEL SERIAL NUMBER LOCATION VIAL WASHING ROOM EFFECTIVE DATE TABLE OF CONTENTS S. No. Description Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 System Description 5.0 Responsibilities And Identification Of Execution Team 6.0 Test Procedures 7.0 Recording …
Read More »SOP on Quality Risk Management
Objective To describe the procedure for management of risks, arising from different operations, activities and discrepancies. Scope This SOP shall cover overall management of risks that arise from different operations, activities, discrepancies, deviations and failures in the manufacturing operations of Pharmaceutical company. Responsibility Each Operating Manager and the Department Head …
Read More »SOP on Acceptable Quality Level (AQL) During Product Inspection for physical defects.
SOP on Acceptable Quality Level (AQL) During Product Inspection for physical defects. ” Product Inspection for Physical defects ” shall be filed in the Batch Production Record of the respective drug product In case the incidence of recurrence of a particular defect is frequent , for consecutive batches, Officer – QA shall …
Read More »ASEPTIC PROCESS SIMULATION (MEDIA FILL)
ASEPTIC PROCESS SIMULATION (MEDIA FILL) Aseptic Process Simulation: Process simulation test, which is also synonymously known as media fill, is the aseptic process, where a microbiological growth medium is substituted to the product, which is manipulated and exposed in a similar way to that of the product. PURPOSE Of ASEPTIC PROCESS …
Read More »DESIGN QUALIFICATION OF BIN WASHING & DRYING SYSTEM
DESIGN QUALIFICATION OF BIN WASHING & DRYING SYSTEM TABLE OF CONTENT Objective Scope Responsibilities Machine description Operating control panel Main electric Panel Technical Specifications of Components & Sub-Components used/ bought outs Details of Utilities Identification of component for calibration Material of construction Enclosures Safety features and alarms Change control procedure …
Read More »DESIGN QUALIFICATION CARTONING MACHINE HI CART (BLISTER PACKING)
DESIGN QUALIFICATION CARTONING MACHINE HI CART (BLISTER PACKING) TABLE OF CONTENT Objective Scope Responsibility (Client and manufacturer) Machine description Technical specifications and make of sub-components/ bought out items. Details of Utilities Identification of components for calibration Material of construction of all components Safety features and alarms FAT procedure Change control …
Read More »DESIGN QUALIFICATION AUTOMATIC CAPSULE FILLING MACHINE
DESIGN QUALIFICATION AUTOMATIC CAPSULE FILLING MACHINE TABLE OF CONTENT Objective Scope Responsibility (Client and manufacturer) URS (User Requirement Specification) Machine description Technical specification Technical specifications of the sub-components / bought out items Details of Utilities Identification of components for calibration Material of construction of components Surface area calculations for capsule …
Read More »DESIGN QUALIFICATION OF FLUID BED PROCESSOR
DESIGN QUALIFICATION OF FLUID BED PROCESSOR TABLE OF CONTENT OBJECTIVE SCOPE RESPONSIBILITIES MACHINE DESCRIPTION FLUID BED DRYER FLUID BED PROCESSOR LOADING & UNLOADING OF MATERIAL EQUIPMENT SUBASSEMBLIES & PARTS MAIN BODY AIR INLET SHUT OFF VALVE BLOWER INLET SHUT OFF VALVE AIR PREPARATION UNIT PRODUCT CONTAINER & TROLLEY DEHUMIDIFIER & …
Read More »SOP on usage of Dynamic pass box
SOP on usage of Dynamic pass box Objective:To lay down a procedure on usage of Dynamic pass box. Scope: This SOP is applicable for usage of Dynamic pass box in formulation plant of pharmaceutical company. Responsibility: Production Officer / Executive shall be responsible for follow the procedure mentioned in this …
Read More »SOP on Artwork Design and Approval
SOP on Artwork Design and Approval Objective: To lay down a procedure for artwork design and approval (of Printed packaging materials). Scope: This Standard Operating Procedure is applicable to all drug products manufactured and marketed by Pharmaceutical company. Responsibility: For Artwork development and approval system of Export markets Head Marketing …
Read More »SOP on writing & approval of Qualification and validation protocol & reports
SOP on writing & approval of Qualification and validation protocol & reports Objective: To describe the procedure for writing & approval of qualification and validation protocols & reports. Scope: This SOP is applicable to all type of qualification and validation protocol & report for all department to Formulation plant of …
Read More »SOP on Control of Sieves and Screens of Different Equipments
Objective:To lay down a procedure for Control of Sieves and Screens of different Equipments. Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company. Responsibility Production Supervisor / Officer shall be responsible for implementation of the procedure as per this SOP. Head-Production / designee shall be responsible for …
Read More »SOP on Control of Change Parts of Machines/Equipments
Objective:To lay down a procedure for the control of change parts. Scope:The standard operating procedure is applicable for formulation plant of Pharmaceutical company for controlling the various change parts of the machines/equipments. Responsibility Trained Worker / Operator shall be responsible for control of change parts. Production Supervisor / Officer shall …
Read More »SOP on Precautions during on line maintenance of machine and re-start operation.
SOP on Precautions during on line maintenance of machine and re-start operation. Objective:To lay down a procedure for precautions during on line maintenance of machine and checks to start its operation. Scope:The standard operating procedure is applicable for formulation plant of Pharmaceutical company. Responsibility Production Supervisor / Officer / Executive …
Read More »SOP on Procedure for Checking of Strips / Blister and Overprinted Packing Materials.
Objective:To lay down a procedure for Checking of Strips / Blister and Overprinted Packing Materials. Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company. Responsibility Production Supervisor / Officer shall be responsible for implementation of this SOP. Head-Production / designee shall be responsible for compliance of this …
Read More »SOP on Precautions during power failure in production area
Objective:To lay down a procedure for precautions during power failure and checks to start the operation. Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company. Responsibility Production Operator / Production Supervisor / Officer shall be responsible for implementation of this SOP. Head-Production / designee shall be responsible …
Read More »SOP on Cleaning and Operating Procedure of Carton Sealing Machine
Objective:To lay down a procedure for cleaning and operating of Carton Sealing machine. Scope: This standard operating procedure is applicable for formulation plant of pharmaceuticcal company, Make and Model: Tapping System, Identification Number. Responsibility Production Operator shall be responsible for operating the machine as per the procedure mentioned in this SOP. …
Read More »SOP on Maintaining of Equipment Log Book
SOP on Maintaining of Equipment Log Book Objective: To lay down a procedure for maintaining of equipment log book. Scope:T his Standard Operating Procedure is applicable for maintaining of equipment log book associated with product (s) manufactured at formulation plant. Responsibility All the concerned personnel shall be responsible to follow …
Read More »SOP On Issuance and Submission of Batch Manufacturing Record (BMR)
SOP On Issuance and Submission of Batch Manufacturing Record (BMR) Objective: To lay down the procedure for issuance and submission of batch manufacturing record (BMR). Scope: This SOP shall be applicable for issuance and submission of batch manufacturing record (BMR) to Production in Formulation plant.. Responsibility Production personnel shall be …
Read More »SOP on Recording of Specimen Signature
SOP on Recording of Specimen Signature Objective: To lay down the procedure to record the specimen signature. Scope: This Standard Operating Procedure is applicable for recording of specimen signature of all the personnel working at Pharmaceutical Company. Responsibility Concerned personnel of all department shall be responsible for following the procedure …
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