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
1.0 Objective: To describe the procedure for operation and cleaning of conveyor belt. 2.0 Scope: This procedure is applicable to conveyor belt. 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 conveyor belt … Read more
1.0 Objective: To describe the procedure for operation and cleaning of cone blender. 2.0 Scope: This procedure is applicable to cone blender 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 machine. There … Read more
1.0 Objective: To describe the procedure for operation and cleaning of coating pan. 2.0 Scope: This procedure is applicable to coating pan 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 machine as … Read more
sop on operation & cleaning of blister packing machine 1.0 Objective: To describe the procedure for operation and cleaning of blister packing machine. 2.0 Scope: This procedure is applicable to blister 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 … Read more