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 …
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 »