Objective: To lay down a procedure for operation of Bung processor cum steam sterilizer. Scope: This SOP is applicable for operation of Bung processor cum steam sterilizer. Responsibility: Production operator / technician – responsible for Operation on Bung processor cum steam sterilizer. Production officer / Executive – to ensure that Operation on Bung processor cum … Read more
Objective: To lay down a procedure for washing and inspection of surgical hand gloves. Scope This SOP is applicable for washing and inspection of the surgical gloves used in production area in formulation plant of pharmaceutical company. Responsibility Production Officer / Executive. Accountability Production Head and QA head shall be accountable for compliance of SOP. … Read more
Objective To lay down a procedure for cleaning of Pass Box. Scope This SOP is applicable for the procedure of cleaning of Pass Box in the formulation plant of pharmaceutical company. Responsibility Production Operator/ Technician – For the cleaning of the equipment. Production Officer/ Executive– To ensure the cleanliness of the equipment. Accountability Production Head … Read more
SOP for washing and inspection of garments. Objective: To lay down a procedure for washing and inspection of garments. Scope: This SOP is applicable for washing and inspection of garments for dry powder Injection facility in formulation. Responsibility: Production operator / technician – responsible for washing and inspection of garments Production officer / Executive – … Read more
DEPARTMENT PRODUCTION NAME OF THE SUPPLIER MODEL SERIAL NUMBER LOCATION VIAL WASHING ROOM EFFECTIVE DATE RUN No. TABLE OF CONTENTS S. No. Description Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 Equipment Description 2.0 Responsibilities And Identification Of Execution Team 6.0 Test Procedures 7.0 Recording Of Observations 8.0 Discrepancy And Corrective Action … Read more
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 Of Observations 8.0 Discrepancy And … Read more
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 shall be responsible for identification … Read more
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 notify the same to Head … Read more
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 SIMULATION : To define the procedure … Read more
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 Design qualification report List of … Read more
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 procedure Qualification Document report approval … Read more
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 and product contact parts Equipment … Read more
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 & MIST ELIMINATOR EXPLOSION FRAME & … Read more
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 SOP. Accountability: Production Head and … Read more
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 shall be responsible for providing … Read more
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 pharmaceutical Company. Responsibility: The officer … Read more
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 compliance of this SOP. Accountability: … Read more
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 be responsible for implementation of … Read more
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 shall be responsible for implementation … Read more
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 SOP. Accountability: Head-Production and Head QA shall … Read more
