Tag: Derbyshire Dales

Operational qualification purified water generation system

Posted on By Pharma Editor

Water generation system Operational qualification The purpose of Operational Qualification is to establish confidence that the Purified Water Generation System is capable of operating within these established limits and tolerances with the following features but not limited to: The functional design specification addresses the permanent recording, visual indication, design/specification range, normal operating range, alert and alarm…

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Validation & Qualification

Protocol for perfomance qualification of water for injection generation, storage and distribution system

Posted on By Pharma Editor

Protocol for perfomance qualification of water for injection generation, storage and distribution system Objective: To establish the methodology for the Performance Qualification of WFI Generation, Storage and Distribution system , which produces pyrogen free, water for injection, used as a Sterile products manufacturing facility. Purpose and Scope The purpose of this Protocol is to establish…

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Engineering

SOP for sterilization of media.

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SOP for sterilization of media. Objective: To lay down a procedure for sterilization of media. Scope: This SOP is applicable for sterilization of media. Responsibility: Production Officers / Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability: Production Head and QA Head shall be accountable for the compliance of SOP. Abbreviations…

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Production

SOP for Cleaning and Sanitization of Drain Point.

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SOP for Cleaning and Sanitization of Drain Point. Objective: To lay down a procedure for cleaning and sanitization of drain point. Scope: This SOP is applicable for cleaning and sanitization of drain point. Responsibility: Production Officers / Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability: Production Head and QA head…

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Production

SOP on Steps to be taken in case of Environmental Failure

Posted on By Pharma Editor

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 mentioned in this SOP. Accountability…

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Production

SOP on Destruction And Disposal of Media Filled Vials

Posted on By Pharma Editor

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 this SOP. Accountability Production Head…

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Production

SOP on Fumigation in Aseptic Area

Posted on By Pharma Editor

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 SOP. Abbreviations QA: Quality Assurance…

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Production

Cleaning and Sanitization procedure of RO and EDI System of Purified water System

Posted on By Pharma Editor

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 : The sanitization has to be…

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Engineering

CHEMICAL CLEANING Reverse RO System and EDI System

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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 % powder) which is to be…

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Engineering

Cleaning & Passivation Procedure Purified water System

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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 ( NaOH) ( of 100% Purity)…

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Engineering

SOP for cleaning and sanitization of uncontrolled area.

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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: Uncontrolled area are primary packing…

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Uncategorized

SOP on cleaning of return air riser filters.

Posted on By Pharma Editor

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 for the compliance of SOP….

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Production

SOP on cleaning of packing conveyor belt.

Posted on By Pharma Editor

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 for this SOP. Abbreviations SOP…

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Production

SOP for Bowie dick test

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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 : Standard Operating Procedure MMI…

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Production

SOP for washing, siliconization and sterilization of Rubber stopper.

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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 for the compliance of SOP….

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Production

Pharmaceuticals Facility and cGMP Expectations

Posted on By Pharmaceutical Guidanace

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 special products. e.g., sterile products….

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Uncategorized

SOP on integrity testing of cartridge filter.

Posted on By Pharma Editor

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 accountable for compliance of SOP….

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Production

SOP on operation of laminar air flow unit

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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 be responsible for the implementation…

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Production