Engineering Question & Answer 1.Question:What is the good engineering practice (GEP) Answer: good engineering practice (GEP) means to established engineering methods and standards that are applied throughout the project life-cycle to deliver appropriate, cost-effective solutions. 2.Question: How can defined the validation ? Answer: The documented act of proving that any procedure, process, equipment, material, activity or system actually leads…
SOP ON ESTABLISHMENT OF ALERT LIMIT AND ACTION LIMIT IN PHARMA The alert limit is reached when the normal operating range of a critical parameter has been exceeded, indicating that corrective measures may need to be taken to prevent the action limit being reached SOP On In-process Control of Packing Line in Pharma
SOP On In-process Control of Packing Line in Pharma OBJECTIVE: To ensure the quality of Finished Products during strip packing and final packing operation of tablets. SCOPE: This SOP shall apply to in-process controls during primary and secondary packing operation of tablets. RESPONSIBILITY : In process Quality Assurance Officer / Executive shall be responsible for follow the…
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SOP on Sampling of Intermediates and Finished Products in Pharma OBJECTIVE: To lay down a procedure for sampling intermediate(blend/core/coated/capsules) and finished products (packing)during manufacturing operations. SCOPE: This SOP shall apply to the IPQA in the Quality Assurance Department. RESPONSIBILITY: In-process Quality Assurance Executive/Officer shall be responsible for following the procedure mentioned in the SOP. ACCOUNTABILITY: Head Quality Assurance…
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SOP On In-process Control during Tablets Manufacturing in Pharma OBJECTIVE: To lay down the procedure for In-process Controls during Tablet Manufacturing. SCOPE: This SOP shall be applicable for in-process controls during tablet manufacturing of pharmaceutical companies. RESPONSIBILITY: The production/Quality Assurance Executive/Officer shall Be responsible for follow the procedure mentioned in this SOP. ACCOUNTABILITY: Head Quality Assurance…
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Objective :To lay down a procedure for Operation of Incinerator. Scope :This Standard Operating Procedure is applicable for the formulation plant of pharmaceutical company. Responsibility: Concerned Technician/Operator shall be responsible for operating the Incinerator as per this SOP. Officer/ Executive- Engineering shall be responsible for the implementation of this SOP. Accountability:Head Engineering and shall be responsible…
Objective:To lay down a Laboratory procedure for the analysis of Treated Effluent. Scope:This standard operating procedure is applicable for formulation plant of pharmaceutical company. Responsibility: ETP chemist shall be responsible for testing of Treated Effluent. COD : Chemical Oxygen Demand D.O :Dissolved Oxygen FAS : Ferrous Ammonium Sulfate BOD : Biochemical Oxygen Demand Abbreviations & Definitions:…
Objective:To lay down a procedure for Cleaning of filters for Dispensing Booth. Scope:This Standard Operating Procedure is applicable to the formulation plant of pharmaceutical company. Responsibility The Concerned Technician shall follow the Cleaning Procedure as per this SOP. The Officer/Executive-Engineering shall be responsible for implementation of this procedure as per this SOP. Accountability:Head-Engineering and QA…
Objective:To lay down a procedure for Preventive Maintenance of Purified Water System (Generation and Distribution). Scope:This Standard Operating Procedure is applicable for formulation plant of pharmaceutical company. Responsibility The Concerned Technician shall follow the procedure for Preventive Maintenance as per this SOP. The Officer/Executive-Engineering shall be responsible for implementation of this procedure as per this…
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Objective:To lay down the Colour Coding system for indicating the contents of Utility Lines. Scope: This Standard Operating Procedure is applicable to the formulation plant of pharmaceutical Company. Responsibility The Concerned Technician shall follow the Colour Coding System as per this SOP. The Officer/Executive-Engineering shall be responsible for implementation of the procedure as per this SOP….
Objective:To lay down a procedure for preparing preventive maintenance procedures or programs for equipment or system and their component(s). Scope:This standard operating procedure is applicable for preparation of Preventive Maintenance procedure or programs for all equipments or systems installed in the formulation plant. Responsibility Officer/ Executive- Engineering shall be responsible for the preparation of Preventive…
Objective:To lay down a procedure for Calibration of equipments and instruments from external authorized Agencies / Supplier. Scope:This procedure shall be applicable for calibration of equipment / instrument of all the departments of pharmaceutical Company Responsibility Head of Engineering: (i) For maintaining records (ii) For the selection of authorized calibration agency / Supplier Heads of…
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Objective:To lay down a procedure for Sanitization of Purified Water Generation and Distribution system. Scope:This Standard Operating Procedure is applicable to the formulation plant of pharmaceutical Company. Responsibility The Concerned Technician shall follow the Sanitization Procedure as per this SOP. The Officer/Executive-Engineering shall be responsible for implementation of the procedure as per this SOP. Accountability:…
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Objective:To lay down an Operating Procedure for Purified Water Distribution System. Scope:This Standard Operating Procedure is applicable to the formulation plant of pharmaceutical Company(Make- Neela Metal,Capacity- 2.5m3/hr) . Responsibility The Concerned Technician shall follow the Operating Procedure as per this SOP. The Officer/Executive-Engineering shall be responsible for implementation of the procedure as per this SOP….
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Scope:This Standard Operating Procedure is applicable to the formulation plant of Pharmaceutical Company(Make-Neela Metal ,Capacity -2.5m3/hr) . Objective:To lay down an Operating Procedure for Purified Water Generation System. Volts: Voltage Amps : Amperes PH : Proportionate Hydrogen Kg/cm2 :Kilogram per Centimeter Square m3/hr :Meter Cube per Hour µS/Cm: Micro Siemens per Centimeter UF: Ultra Filtrations EDI…
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Objective:To lay down an Operating Procedure for Dehumidifier Scope:This Standard Operating Procedure is applicable to the formulation plant of Pharmaceutical Company. Responsibility The Concerned Technician shall follow the Operating Procedure as per this SOP The Officer/Executive-Engineering shall be responsible for implementation of the procedure as per this SOP. Accountability: Head-Engineering and QA shall be accountable for…
Objective:To lay down an Operating Procedure for Air Handling Units, Exhaust,Supply and Ventilations Units. Scope:This Standard Operating Procedure is applicable to the formulation plant of Pharmaceutical Company. Responsibility: The Concerned Technician shall follow the Operating Procedure as per this SOP The Officer/Executive-Engineering shall be responsible for implementation of the procedure as per this SOP. Accpuntability: Head-Engineering/Designee…
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Scope:This Standard Operating Procedure is applicable to the formulation plant of Pharmaceutical company. Objective:To lay down a procedure for Operation of Effluent Treatment Plant. Responsibility: Concerned Technician/Operator shall be responsible for Operating the ETP as per this SOP. Officer/Executive-Engineering shall be responsible for implementation of the procedure as per this SOP. Accountability:Head-Engineering and QA shall be…
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Objective:To lay down a procedure for building Maintenance. Scope:This Standard Operating Procedure is applicable for the formulation plant of Pharmaceutical Company. Responsibility:Head-Engineering /Designee shall be responsible for implementation of the procedure as per this SOP Accountability:Head-Concerned Department and QA shall be accountable for compliance of the procedure as per this SOP. Abbreviations and Definitions: SOP…
Objective :To lay down a procedure for Breakdown Maintenance of the Equipment’s and Machines. Scope :This Standard Operating Procedure is applicable for the formulation plant of Pharmaceutical company. Responsibility The Concerned Technician shall follow the Breakdown Maintenance Procedure as per this SOP. Head-Concerned Department / Area Incharge shall be responsible for intimating the Engineering Department…
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