SOP on New Product Design and Development Process The objective of the New Product Design and Development Process : To lay down a Procedure for New Product Design and Development Process. Scope : This Standard Operating Procedure is applicable all pharmaceutical formulation plants of Pharmaceutical Companies. Responsibility Head, Clinical Research: Conducting Clinical Trials as per…
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SOP On In-process Control of Packing Line OBJECTIVE : To ensure quality of Finished Products during strip packing and final packing operation of tablets. SCOPE: This SOP shall be applicable in-process controls during primary and secondary packing operation of tablets. RESPONSIBILITY : In process Quality Assurance Officer / Executive shall be responsible for follow the…
SOP on Sampling of Intermediates and Finished Products OBJECTIVE : To lay down a procedure for sampling of intermediate(blend/core/coated/capsules) and finished products (packing)during manufacturing operations. SCOPE: This SOP shall be applicable to the IPQA in Quality Assurance Department. RESPONSIBILITY: In process Quality Assurance Executive/Officer shall be responsible for follow the procedure mentioned in the SOP….
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SOP On In-process Control During Tablets Manufacturing OBJECTIVE: To lay down the procedure for In process Controls during Tablet Manufacturing. SCOPE : This SOP shall be applicable for in process controls during tablets manufacturing of pharmaceutical company. RESPONSIBILITY: Production /Quality Assurance Executive/Officer shall Be responsible for follow the procedure mentioned in this SOP. ACCOUNTABILITY :…
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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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SOP on Line Clearances OBJECTIVE : Ensure that the area and equipment, required for the manufacturing and packing activities of pharmaceutical products are free from any potential sources of cross-contamination/ mix-ups. SCOPE: The line clearance procedure is applicable to all activities including dispensing, manufacturing, packaging, and related activities. Responsibility: The officer/ Executive of the respective…
