SOP for Operation on vial washing machine To lay down a procedure for the operation of vial washing machine (Make-Ambica). Scope of SOP : This SOP is applicable for operation of vial washing machine. Responsibility: Production operator / technician – responsible for operation of machine. Production officer / Executive – to ensure …
Read More »Operation on Bung processor cum steam sterilizer.
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 …
Read More »SOP for washing and inspection of surgical hand gloves.
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 …
Read More »SOP for cleaning of Pass Box
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 …
Read More »SOP for washing and inspection of garments.
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 …
Read More »Revalidation Protocol Steam Sterizer
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 …
Read More »Performance Qualification Protocol of Tunnel Sterilizer
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)
CARTONING MACHINE HI CART (BLISTER PACKING) The machine performs the following functions: Storing of pre-broken cartons in flat form in the carton magazine. Picking up the cartons from carton magazine. Opening / erecting the carton. Closing one side. Loading Leaflet. Loading product Closing other side. The machine consists of the …
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
FLUID BED PROCESSOR The Principle of Fluid Bed Dryer is to create a fluidal turbulence in and a granulated or Powdery wet product by means of hot air or dehumidified air flowing in an upward Direction & to dry the same to the final required degree in a careful manner. …
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 …
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