Objective To lay down the steps to be taken in case of environment failure in the aseptic area of Sterile Dry Powder Injectables facility. Scopе This SOP describes the steps to be taken in case of environmental failure. Responsibility Production Officers / Executive shall be responsible for follow the procedure …
Read More »SOP on Destruction And Disposal of Media Filled Vials
SOP on Destruction And Disposal of Media Filled Vials Objective: To lay down a procedure on destruction and disposal of media filled vials. Scope This SOP is applicable for destruction and disposal of media filled vials. Responsibility Production officer / Executive shall be responsible for follow the procedure mentined in …
Read More »SOP on Fumigation in Aseptic Area
Objective To lay down a procedure for fumigation in aseptic area. Scope The SOP describes the procedure for fumigation in aseptic area. Responsibility Production Officer / Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability Production Head and Qa head shall be accountable for compliance of …
Read More »Cleaning and Sanitization procedure of RO and EDI System of Purified water System
CLEANING AND SANATIZATION (PASSIVATION) REPORT SYSTEM: PURIFIED WATER GENERATION SYSTEM Objective: The system needs cleaning and sanitization before start of the plant and loading of RO membrane to remove any microbial load or any bio film present in the existing interconnecting piping and the RO Housing and Pumps. Procedure : …
Read More »CHEMICAL CLEANING Reverse RO System and EDI System
CHEMICAL CLEANING Reverse RO System and EDI System RO CLEANING – CITRIC ACID Preparation of Cleaning solution: Prepare a solution of 2% (By weight) of Citric acid (C6H8O7). This is useful in removing of inorganic scales and organic based colloidal material. Recommended quantity is 7.7 kg Citric acid (100 % …
Read More »Cleaning & Passivation Procedure Purified water System
Cleaning & Passivation Procedure Purified water System Fill the Storage Tank upto the Half Level & Start the recirculation pump & circulate water for 25-30 minutes Then drain the water from the Tank & piping ( Via User Points, & Sampling Points.) Prepare cleaning chemical by diluting Sodium Hydroxide ( …
Read More »SOP for cleaning and sanitization of uncontrolled area.
SOP for cleaning and sanitization of uncontrolled area. Objective: To lay down a procedure for cleaning and sanitization uncontrolled area. Scope: This SOP is applicable for cleaning and sanitization of uncontrolled area. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. Ltr.: Liter Procedure: …
Read More »SOP on cleaning of return air riser filters.
Objective: To lay down a procedure for cleaning of return air riser filters. Scope This SOP is applicable for cleaning of return air riser filters. Responsibility Production Officers / Executive shall be responsible for follow the procedure mention in this SOP. Accountability Production Head and QA Head shall be accountable …
Read More »SOP on cleaning of packing conveyor belt.
Objective: To lay down a procedure for cleaning of packing conveyor belt Scope This SOP is applicable for cleaning of packing conveyor belt. Responsibility Officers or above of Production personnel shall be responsible for follow the procedure mentioned in this SOP. Accountability Production Head and QA Head shall be accountable …
Read More »SOP for Bowie dick test
Objective: To lay down a procedure for bowie dick test Scope: This SOP is applicable for Bowie Dick test in pharmaceutical plant. Responsibility: Production Officers /Executive shall be responsible for follow the procedure mentioned in this SOP.. Accountability: Production Head shall be accountable for the compliance of SOP. Abbreviations SOP …
Read More »SOP for washing, siliconization and sterilization of Rubber stopper.
Objective: To lay down a procedure for washing, siliconization, sterilization and drying of Rubber stopper. Scope: This SOP is applicable for washing, siliconization, sterilization and drying of Rubber stopper. Responsibility: Production Officers/ Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability: Production Head shall be accountable …
Read More »Pharmaceuticals Facility and cGMP Expectations
Current Good Manufacturing Practices in Pharmaceutical Industry The cGMP requirements are described in the various guidelines which deal mainly in the following categories, e.g., (A) Requirements related to surroundings. (B) General requirements for pharmaceutical plants. (C) Requirements related to various departmental areas in the plant and (D) Requirements related to …
Read More »SOP on integrity testing of cartridge filter.
Objective To lay down a procedure for integrity testing of cartridge filter. Scope This SOP is applicable for integrity testing of cartridge filter in formulation plant. Responsibility Production officer / Executive shall be responsible for follow the procedure mentined in this SOP. Accountability Production Head and QA Head shall be …
Read More »SOP on operation of laminar air flow unit
Objective: To lay down a procedure for operation of laminar air flow unit. Scope This SOP is applicable for operation of laminar air flow unit of Dry Powder Injectable facility. Responsibility Officers or above Production shall be responsible for follow the procedure mentined in this SOP. Accountability Production Head shall …
Read More »Stability testing of new drug substances and products
[embeddoc url=”https://pharmaguidances.com/wp-content/uploads/2016/10/STABILITY-TESTING-OF-NEW-DRUG-SUBSTANCES-AND-PRODUCTS-1.pptx” download=”none” viewer=”microsoft” Pharma More Jobs and post Please click here
Read More »Temparature Mapping
Temparature Mapping Pharma More Jobs and post Please click here
Read More »Vial inspection machine
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 …
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