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…
Objective:To lay down a procedure for the handling of Primary Standard. Scope:This Standard Operating Procedure is applicable to Quality Control Department followed at Pharmaceutical Company name with location. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head & QA Head shall be accountable for implementation of this SOP. Abbreviations and Definitions:…
Stability study of volumetric solution Volumetric solutions, called titrants, are meticulously formulated solutions whose concentrations are precisely determined. These are extremely important in quantitative analysis where measurement accuracy is of paramount importance. Prominent examples include standard solutions of acids, bases, and salts used in titrations. These solutions are meticulously prepared according to established protocols and…
Good Laboratory practices (GLP) in quality control To define a procedure for Good Laboratory Practices (GLP). SCOPE This SOP is applicable for quality control department for procedures for Good Laboratory Practices. DEFINITION(S) & ABBREVIATION(S) DEFINITION(S) Good Laboratory Practices (GLP) is a quality system concerned with organizational process and conditions under which non-clinical health and environment…
ANALYST QUALIFICATION PURPOSE of ANALYST QUALIFICATION: To lay down the procedure for the qualification of analyst in order to confirm that the newly Joined employee analyst and analyst performing tests in quality control laboratory are adequately qualified to produce reliable and accurate results. SOP SCOPE ANALYST QUALIFICATION: This SOP applicable to Quality Control RESPONSIBILITY: Analyst:…
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