sop for sampling and testing of drain water 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for sampling (before sanitization and after sanitization) and testing of drain water. 2.0 SCOPE 2.1 This SOP is applicable for sampling for sampling (before sanitization and after sanitization) and testing of drain … Read more
Validation for cleaning procedure liquid injection SCOPE OF VALIDATION LIQUID INJECTION PROTOCOL NO. SUPERSEDES EFFECTIVE DATE TABLE OF CONTENTS Sr. No. SECTION TITLE PAGE No. 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW 2.1 OBJECTIVE 2.2 PURPOSE 2.3 SCOPE 2.4 RESPONSIBILITY 2.5 REVALIDATION 2.6 CLEANING TYPES EQUIPMENT DETAILS EXPERIMENTAL PLAN – CLEANING PROCEDURE CHECK LIST FOR CLEANING … Read more
Validation for cleaning procedure dry powder injection SCOPE OF VALIDATION DRY POWDER INJECTION PROTOCOL NO. SUPERSEDES EFFECTIVE DATE 15-03-2012 TABLE OF CONTENTS Sr. No. SECTION TITLE PAGE No. 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW 2.1 OBJECTIVE 2.2 PURPOSE 2.3 SCOPE 2.4 RESPONSIBILITY 2.5 REVALIDATION 2.6 CLEANING TYPES 2.7 APPROACH 2.8 EXECUTION OF PLANNING 3.0 CLEANING … Read more
SOP FOR PERSONNEL QUALIFICATION PROTOCOL FOR ASEPTIC AREA SUPERDEDES PROTOCOL No. AREA NAME S. No. Title Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 Responsibility 5.0 Reason for Qualification 6.0 Requalification Criteria 7.0 Training details 8.0 … Read more
HOLD TIME STUDY PROTOCOL FOR STERILIZED MEDIA S. No Description 1.0 Protocol Approval 2.0 Objective 3.0 Purpose and Scope 4.0 Responsibility 5.0 Qualification Team 6.0 Training 7.0 Methodology 8.0 Acceptance Criteria 9.0 Qualification report 10.0 Approval of qualification report 11.0 Re-qualification 12.0 Discrepancy And Corrective Action Report 13.0 Abbreviation 1.0 PROTOCOL APPROVAL This … Read more
sop for Training of Plant Personnel REVISION SUMMARY Version Number Date Revised Reason for Revision 00 Effective Date : First Issue 01 Effective Date : Incorporation of Qualification, Questionnaire and Evaluation Criteria of employee. 1.0 OBJECTIVE 1.1 To organize and conduct training program to all the plant employees at all levels. 2.0 … Read more
sop for endotoxin challenge test 1.0 OBJECTIVE : To lay down a procedure for Endotoxin Challenge Test. 2.0 SCOPE : This SOP is applicable for Endotoxin Challenge Test in Microbiology Lab. Of Quality Control Department 3.0 RESPONSIBILITY : 3.1 Officer / Executive – QC (Microbiology) 4.0 ACCOUNTABILITY : 4.1 Head – QC 5.0 DEFINITION … Read more
1.0 Objective: To describe the procedure for operation and cleaning of Alu-Alu packing machine. 2.0 Scope: This procedure is applicable to Alu-Alu packing machine 3.0 Responsibility: Operator / Production Officer / Executive 4.0 Accountability: Department Head shall be accountable for the compliance of the system. 5.0 Procedure: 5.1 Operation: 5.1.1 Check the cleanliness of the … Read more
1.0 Objective: To describe the procedure for tablet packing. 2.0 Scope: This procedure is applicable to packing department 3.0 Responsibility: Production Officers / Executive. 4.0 Accountability: Department Head shall be accountable for the compliance of the system. 5.0 Procedure: 5.1 Planning & Scheduling of Program: 5.1.1 Prepare daily plan as per delivery schedule of planning … Read more
1.0 Objective: To describe the procedure for receipt, storage and handling of dispensed packing Materials. 2.0 Scope: This procedure is applicable to receipt, storage and handling of dispensed packing materials in production area 3.0 Responsibility: Production Officers / Executive. 4.0 Accountability: Department Head shall be accountable for the compliance of the system. 5.0 Procedure: … Read more