Objective: To lay down a procedure for operation of vial inspection machine. Scope: This SOP is applicable for inspection of filled & sealed vials. Responsibility: Production Officer/ Executive shall be responsible for follow the procedure mentioned in this SOP.. Accountability: Production Head and Head QA shall be accountable for the …
Read More »SOP on assembling of vial filling & bunging machine
Objective: To lay down a procedure for assembling of vial filling & bunging machine. Scope: This SOP describes the procedure for assembling of vial filling & bunging machine. Responsibility: Production operator / technician – responsible for assembling of vial filling & bunging machine. Production officer / Executive – to ensure …
Read More »SOP for operation of strapping machine
Objective: To lay down a procedure for Operation of strapping machine. Scope This SOP is applicable for Operation of Strapping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP: Standard Operating Procedure. No.:Number Procedure Operation of Strapping Machine. Obtain the carry strap roll from production officer. …
Read More »SOP on Filtration of disinfectant solution and water for injection through cartridge filter.
Objective: To lay down a procedure on filtration of disinfectant solution and water for injection through cartridge filter. Scope This SOP is applicable for filtration of disinfectant solution and water for injection through cartridge filter. Responsibility Officers or above – Production shall be responsible for follow the procedure mentined in …
Read More »SOP on Decartoning of Vials.
Objective: To lay down a procedure for Decartoning of Vials. Scope This SOP is applicable for Decartoning of vials. Responsibility Production officer / Executive. Accountability Production Head and Head QA shall be accountable for the compliance of SOP. Abbreviations Not Applicable Procedure Get the vials issued as per the batch …
Read More »SOP for Operation on vial washing machine
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
TUNNEL STERILIZER Sterilizing and depyrogenating tunnel enables the integration of the process of sterilization and depyrogenation of washed empty vials for sterile, continuous automatic filling in which all steps are performed under Grade A conditions. The Tunnel is comprised of four zones, i.e. Drying zone, sterilizing zone, cooling zone, and …
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
BIN WASHING & DRYING SYSTEM MACHINE DESCRIPTION The Bin Washing & Drying System is an automatic system with services like portable water, purified water, hot water, and boiler steam. The basic operation cycle will be as follows:- Portable water pre-wash from inside and outside. Hot water washes from inside and …
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
AUTOMATIC CAPSULE FILLING MACHINE MACHINE DESCRIPTION The basic Automatic capsule-filling machine consists of the following sub-assemblies Structure Assembly This houses the main drive motor, powder drive motor, pneumatic and vacuum piping, all drive elements, and electrical control cabinet. The structure is enclosed on all four sides by removable covers. Removing …
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 …
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