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 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
handling and investigation of Market Complaints OBJECTIVE : 1.1 To lay down a procedure for handling and investigation of Market Complaints. 2.0 SCOPE : 2.1 This procedure is applicable to all written or oral market complaints (regarding finished product manufactured at ABC Pharma Private Limited) received either from customers, regulatory authorities or distribution … Read more
Assigning identification numbers to equipment 1.0 OBJECTIVE : 1.1 To lay down a procedure to identify the name and no of equipment/instrument 2.0 SCOPE : 2.1 This procedure is applicable to Assigning identification numbers to all the equipment/instrument installs at ABC Pharma Private limited 3.0 RESPONSIBILITY : 3.1 Officer/Executive/Head of user department: … Read more
sop for Corrective and Preventive Action 1.0 OBJECTIVE: 1.1 To lay down the procedure for handling of Corrective and Preventive Action. 2.0 SCOPE: 2.1 This SOP is applicable for all Corrective and Preventive Action that are recommended if any, but not limited to the following documents: 2.1.1 Deviation 2.1.2 Out of specification … Read more
Preparation of Site Master File 1.0 OBJECTIVE : 1.1 To lay down a procedure for preparation of Site Master File. 2.0 SCOPE : 2.1 This procedure is applicable for preparation of Site Master File at ABC pharma Private Limited Roorkee. 3.0 RESPONSIBILITY : 3.1 Officer / Executive QA or designee shall be … Read more
Collection Storage Periodic Observation and Destruction of Raw Material and Finished Product Reference Samples 1.0 OBJECTIVE : 1.1 To lay down a procedure for collection and storage of raw material and finished product reference samples as well as periodic observation of Finished Product Reference sample. 2.0 SCOPE : 2.1 This procedure is applicable … Read more
Preparation Approval Control and Distribution of Master Formula Records 1.0 OBJECTIVE : 1.1 To lay down a procedure for preparation, approval, control and distribution of Master Formula Records for manufacturing as well as packing of finished pharmaceutical products. 2.0 SCOPE : 2.1 This procedure is applicable to preparation, approval, control and distribution of … Read more
Retention and disposal of documents and records OBJECTIVE : 1.1 To lay down a procedure for retention of obsolete/discontinued documents and filled records and disposal after retention period. 2.0. SCOPE : 2.1 This procedure is applicable to obsolete/discontinued documents as well as filled records being … Read more
performance qualification protocol for water for injection EQUIPMENT ID. No. LOCATION WFI GENERATION AREA SUPERSEDES PROTOCOL No. NIL PROTOCOL CONTENTS S. NO. TITLE PAGE NO. 1.0 PROTOCOL APPROVAL 2.0 OBJECTIVE 3.0 SCOPE 4.0 RESPONSIBILITY 5.0 EQUIPMENT DETAILS 6.0 SYSTEM … Read more