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 …
Read More »Calibration of Equipment and Instruments from External Authorized Agencies / Suppliers
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 …
Read More »Sanitization of Purified Water Generation and Distribution System
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 …
Read More »Operating Procedure for Purified Water Distribution System
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 …
Read More »Operating Procedure for Purified Water Generation System
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 …
Read More »Operating Procedure of Dehumidifier
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 …
Read More »Operating Procedure of Air Handling Units and Ventilations Units
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 …
Read More »Operating Procedure for Effluent Treatment Plant
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. …
Read More »Procedure for Building Maintenance
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 …
Read More »Breakdown Maintenance Procedure of the Equipments and Machines
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 …
Read More »SOP on Line Clearances
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 …
Read More »SOP on Handling of Primary Standard
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 …
Read More »Stability study of volumetric solution
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 …
Read More »Good Laboratory Practices (GLP)
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 …
Read More »SOP on Analyst Qualification in quality control
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 …
Read More »SOP on handling of Out of trend (OOT)
Objective:To lay down a procedure for handling of Out of trend for stability sample Scope:This procedure shall be applicable for handling of out of trend of stability sample at quality control of pharmaceutical company name with location. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head …
Read More »SOP on procurement and handling of working standards
SOP on procurement and handling of working standards Objective:To lay down a procedure for the procurement and handling of working standards. Scope:This SOP is applicable for procurement and handling of working standards in quality control laboratory of pharmaceutical company name with location. Responsibility:Chemist or above of QC laboratory shall be …
Read More »SOP on Procedure of volumetric solution preparation and standardization
SOP on Procedure of Volumetric solution preparation and standardization To lay down a procedure for preparation and standardization of volumetric solution. Scope Of SOP: This SOP is applicable for the preparation and standardization of volumetric solutions in a quality control laboratory in a pharmaceutical company name with location. Responsibility: An …
Read More »SOP on Procedure for sampling of raw material
Raw material SOP on Procedure for a sampling of raw material Objective: To lay down the procedure for sampling raw material. Scope: This procedure is applicable for a sampling of raw material in a Pharmaceutical company name with location. Responsibility: QC personnel shall be responsible for following the procedure mentioned …
Read More »SOP on calibration of glassware
Objective:To lay down the procedure for calibration of laboratory glassware. Scope:This SOP is applicable for calibration of laboratory glassware in Quality Control Department at pharmaceutical company name with location. Responsibility:Chemist or above of QA shall be responsible to follow the procedure mentioned in this SOP. Accountability:Department Head & QA Head …
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