| Responsibility of IPQA Personnel |
1.0 OBJECTIVE To lay down the procedure for the responsibilities of IPQA personnel in sterile dry powders, liquid injection and General Product. 2.0 SCOPE This procedure is applicable for the responsibilities of IPQA in sterile dry powder Injection. 3.0 RESPONSIBILITY • Officer or above – IPQA 4.0 ACCOUNTABILITY Head Quality / QA 5.0 PROCEDURE 5.1 Following activities are to be performed during Dispensing, Manufacturing & Packaging by IPQA personnel operation wise, but not limited to; 5.2 Responsibilities of IPQA personnel in sterile dry powders Injection 5.2.1 Dispensing Operation: 5.2.1.1 Line clearance: Area and equipment should be free from remain of previous material. 5.2.1.2 Temperature & RH: Temperature and RH should be within the limits in area. 5.2.1.3 QC A.R Number: Approved raw materials should be dispensed considering FIFO system. 5.2.1.4 Calculation of RM active: Calculation on the basis of assay and moisture/LOD. 5.2.1.5 Balance Calibration: Balance should be calibrated. 5.2.1.6 Dispense quantity: Dispense quantity should match with standard quantity. 5.2.2 Rubber Stoppers Washing and Sterilization: 5.2.2.1 Line clearance: Area and equipments should be free from remnant of previous products. 5.2.2.2 Label status: check the cleaned labels are attached to the equipments in production department. 5.2.2.3 Equipments log book: On line filling of equipment logbook should be followed. 5.2.2.4 On line filling of BMR: Manufacturing steps should be followed. 5.2.2.5 Ensure the availability of rubber stoppers to be washed and shall carried out as per current SOP of steam sterilize (autoclave). 5.2.3 Filling Machine Parts and Accessories Washing and Sterilization: 5.2.3.1 Check and ensure that all the filling machine parts and accessories are washed and sterilized as per the current SOP of cleaning of machine parts & steam sterilizer (autoclave). 5.2.4 Vial Washing and De-pyrogenation: 5.2.4.1 Line clearance: Area and equipment should be free from remnant of previous materials. Ensure the availability of vials to be washed. 5.2.4.2 Equipments Logbook: On line equipments filling of logbook should be followed. 5.2.4.3 On-line filling of BMR/BPR: manufacturing steps should be followed and recorded online. 5.2.4.4 Ensure that current SOP is followed for washing and de-pyrogenation. 5.2.5 Vial Filling and Sealing: 5.2.5.1 Line clearance: Area and equipment should be free from remnant of previous materials. 5.2.5.2 Ensure that temperature and Relative humidity are within the limits. 5.2.5.3 Ensure that the availability of API product details and target fill weight calculation. 5.2.5.4 Equipments Logbook: On line equipments filling of logbook should be maintained. 5.2.5.5 On-line filling of BMR/BPR: manufacturing steps should be followed and recorded online. Ensure that current SOP is followed for vial filling and sealing. 5.2.6 Optical Inspection: 5.2.6.1 Line clearance: Area and equipment should be free from remnant of previous materials. 5.2.6.2 Ensure that temperature and Relative humidity are within the limits. 5.2.6.3 Status label: Semi finished materials should be labeled properly. 5.2.6.4 Equipments Logbook: On line optical inspection machine logbook should be maintained. 5.2.6.5 On-line filling of BMR/BPR: manufacturing steps should be followed and recorded online. 5.2.6.6 Destruction of rejection: Rejected materials should be destroyed in the presence of IPQA personnel. 5.2.7 Labeling and Packing Operation: 5.2.7.1 Line clearance of equipments: Area and equipments should be free from remnant of previous materials. 5.2.7.2 Temperature should be within the specified limits as per BMR/BPR. 5.2.7.3 Equipments logbook: Online filling of equipments logbook should be followed. Ensure online filling of BMR/BPR during packing. 5.2.7.4 Coding approval: IPQA personnel shall verify the initial coding prior to start the activity. 5.2.7.5 Retention/Stability samples to be collected: Define sampling quantity to be collected as per SOP of retention sample. 5.2.7.6 Stereo destruction: Stereo should be destroyed in the presence of IPQA personnel. 5.2.7.7 Destruction of rejection: Rejected materials should be destroyed in the presence of IPQA personnel. 5.2.7.8 FGT Note verification: Before sending the finished material to ware house FGT should be signed by IPQA personnel. 5.2.7.9 Verification of online rejected materials: IPQA personnel should verify on line rejected materials. 5.2.7.10 Preparation of Release Note: Release note of product to be prepare after BMR/BPR review. 5.2.7.11 Verification of reconciliation record in BMR/BPR: IPQA personnel shall counter check the reconciliation record in BMR / BPR. 5.2.7.12 IPQA personnel shall co-ordinate with other department regarding validation activities. 5.2.7.13 In case of any failure inform to concern person for rectification and activity shall be allowed after corrective action has been taken. 5.2.7.14 IPQA personnel shall check if any deviation /investigation has been filed/carried out prior to starts the next operation. To Read this SOP Click Here SOP for Visual Inspection in Sterile Bulk & Formulation. 5.3 Responsibilities of IPQA personnel in liquid injection and General Product 5.3.1 Dispensing Operation: 5.3.1.1 Line clearance: Area and equipment should be free from remain of previous material. 5.3.1.2 Temperature & RH: Temperature and RH should be within the limits. 5.3.1.3 QC A.R Number: Approved raw materials should be dispensed considering FIFO system. 5.3.1.4 Calculation of RM active: Calculation on the basis of assay and moisture/LOD. 5.3.1.5 Balance Calibration: Balance should be calibrated. 5.3.1.6 Dispense quantity: Dispense quantity should match with standard quantity. 5.3.2 Rubber Stoppers Washing and Sterilization: 5.3.2.1 Line clearance: Area and equipments should be free from remnant of previous products. 5.3.2.2 Label status: check the cleaned labels are attached to the equipments. 5.3.2.3 Equipments log book: On line filling of equipment logbook should be followed. 5.3.2.4 On line filling of BMR: Manufacturing steps should be followed. 5.3.2.5 Ensure the availability of rubber stoppers to be washed and shall carried out as per current SOP of steam sterilize (autoclave). 5.3.3 Filling Machine Parts and Accessories Washing and Sterilization: 5.3.3.1 Check and ensure that all the filling machine parts and accessories are washed and sterilized as per the current SOP of cleaning of machine parts & steam sterilizer (autoclave). 5.3.4 Vial Washing and De-pyrogenation: 5.3.4.1 Line clearance: Area and equipment should be free from remnant of previous materials. Ensure the availability of vials to be washed. 5.3.4.2 Equipments Logbook: On line equipments filling of logbook should be followed. 5.3.4.3 On-line filling of BMR/BPR: manufacturing steps should be followed and recorded online. 5.3.4.4 Ensure that current SOP is followed for washing and de-pyrogenation. 5.3.5 Batch Manufacturing and Filtration 5.3.5.1 Line clearance: Area and equipment should be free from remnant of previous materials. 5.3.5.2 Ensure that temperature and Relative humidity are within the limits. 5.3.5.3 Ensure that the availability of API product details as per BMR BOM calculation. 5.3.5.4 Equipments Logbook: On line equipments manufacturing and holding tank and filtration details should be maintained. 5.3.5.5 On-line filling of BMR/BPR: manufacturing steps should be followed and recorded online. Ensure that current SOP is followed for manufacturing and filtration of bulk product. 5.3.6 Vial Filling and Sealing: 5.3.6.1 Line clearance: Area and equipment should be free from remnant of previous materials. 5.3.6.2 Ensure that temperature and Relative humidity are within the limits. 5.3.6.3 Ensure that the bulk solution result should be passed from QC and target filled volume should be verified from BMR. 5.3.6.4 Equipments Logbook: On line equipments filling of logbook should be maintained. 5.3.6.5 On-line filling of BMR/BPR: manufacturing steps should be followed and recorded online. Ensure that current SOP is followed for vial filling and sealing. 5.3.7 Optical Inspection: 5.3.7.1 Line clearance: Area and equipment should be free from remnant of previous materials. 5.3.7.2 Ensure that temperature and Relative humidity are within the limits. 5.3.7.3 Status label: Semi finished materials should be labeled properly. 5.3.7.4 Equipments Logbook: On line optical inspection machine logbook should be maintained. 5.3.7.5 On-line filling of BMR/BPR: manufacturing steps should be followed and recorded online. 5.3.7.6 Destruction of rejection: Rejected materials should be destroyed in the presence of IPQA personnel. |
