Preventive Maintenance Policy

    Preventive Maintenance Policy   1.0 Objective To lay down a procedure for the Preventive Maintenance Policy. 2.0 Scope This Standard Operating Procedure is applicable for Preventive Maintenance Policy to be followed at formulation plants of abc pharma Pvt.Ltd. 3.0 Responsibility 3.1 Engineering Officer / Executive shall be responsible for the execution of this … Read more

master formula record deflazacort suspension

    master formula record deflazacort suspension   Product Code Product (Brand) Name Deflazacort Suspension Generic Name Deflazacort Suspension Label Claim Each 5 ml contains Deflazacort 6 mg Excipients q. s. Color As per approved color Primary Pack Description Filled in Amber color pet bottles. Fill Volume 30 ml , 60 ml Product Description Yellowish … Read more

operation of double door autoclave

  operation of double door autoclave   1 OBJECTIVE Double door autoclave is used for sterile zing media, glasswares, equipments, garments, etc. required to be used in microbiology lab. 2 SCOPE This procedure is applicable for operation of double door autoclave which is installed in microbiology lab at ABC pharma . 3 RESPONSIBILITY Microbiologist. 4 … Read more

sop for Replacement of Vent filters

  sop for Replacement of Vent filters   1.0 Objective To lay down a procedure to organize replacement activity of vent filters. 2.0 Scope This Standard Operating Procedure is applicable for organize replacement activity of vent filters to be followed at formulation plants of ABC Pvt.Ltd. 3.0 Responsibility 3.1 Engineering Officer / Executive shall be … Read more

calibration policy for equipment and instruments

  calibration policy for equipment and instruments   1.0 OBJECTIVE : 1.1 To lay down a procedure for calibration policy of all the testing and measuring instruments used to measure critical processes which can have impact on the quality of the product. 2.0. SCOPE : 2.1 This procedure covers calibration of measuring instruments used in … Read more

Batch release procedure for finished products for sale

  Batch release procedure for finished products for sale   1.0 OBJECTIVE: 1.1 To lay down a procedure for approval and release of finished products for sale. 2.0 SCOPE: 2.1 This Standard Operating Procedure (SOP) is applicable for approval and release of finished products for sale manufactured at ABC Pharma 3.0 RESPONSIBILITY: 3.1 Production Manager … Read more

sop for Handling of Deviations

  sop for Handling of Deviations   1.0 OBJECTIVE : 1.1 To lay down a procedure to describe the requirements to ensure that the events that could impact, directly or indirectly, the identity, strength, efficacy, quality, safety, potency or purity of materials and products are investigated, reviewed, documented and reported in a timely and standardized … Read more

sop for Line Clearance

  sop for Line Clearance   1.0 OBJECTIVE : 1.1 To lay down the Procedure for Line Clearance. 2.0. SCOPE : 2.1 This procedure is applicable for Line Clearance of Production and warehouse dispensing Area by Quality Assurance personnel at ABC Pharma Pvt Ltd. 3.0 RESPONSIBILITY : 3.1 Executive/Supervisor of In Process Quality Assurance 4.0 … Read more

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