Follow
| Sl. No. | Title |
| 1 | Preparation, Review, Approval, Control and Revision of Standard Operating Procedures |
| 2 | Preparation, Review and Approval of Validation Master Plan |
| 3 | Process Validation |
| 4 | Document Control Procedure |
| 5 | Sampling Procedure for In Process materials and Finished Product |
| 6 | Handling of Deviation |
| 7 | Change Control Procedure |
| 8 | Sampling Procedure for Packaging Materials |
| 9 | Self Inspection Procedure |
| 10 | Handling of Market Complaint |
| 11 | Drug Product Recall |
| 12 | Signature Identification |
| 13 | Sampling of Raw Material |
| 14 | Operation and Cleaning of Reverse Laminar Air Flow |
| 15 | Work Permit |
| 16 | Cleaning of Sampling Tools |
| 17 | Batch Numbering System |
| 18 | Material Management |
| 19 | Collection, Storage, Review and Destruction of Retain Samples |
| 20 | Development, Approval and Revision of Packaging Material Art Work |
| 21 | Preparation of Site Master File |
| 22 | Cleaning Validation |
| 23 | Finished Goods Release Procedure |
| 24 | Handling of Corrective Action and Preventive Action (CAPA) |
| 25 | Execution of Pharmacopoeial Changes |
| 26 | Preparation, Review and Approval of Equipment, Utilities Qualification Document |
| 27 | Preparation and Control of Price List |
| 28 | Procedure for Cleaning, Operation & Calibration of Tablet Hardness Tester |
| 29 | Procedure for Resealing of Raw Material Container after Sampling / Dispensing |
| 30 | Procedure for Leak Test |
| 31 | In Process Control in Solid Orals Packing |
| 33 | Shelf-Life of Finished Product |
| 34 | Annual Product Review |
| 35 | Creation of Master for Bill of Material (BOM) |
| 36 | In Process Control in Tablet Manufacturing |
| 37 | Destruction Procedure for In Process Samples |
| 38 | In process Control in Capsule Manufacturing |
| 39 | Operation and Calibration of Friability Test Apparatus. |
| 40 | Operation and Calibration of Disintegration Test Apparatus Make and Model. |
| 41 | Transfer of Packed Finished Goods from Packing to Bonded Store Room |
| 42 | Disposal of Non Conforming Materials |
| 43 | Online Rejection of Raw Materials and Packing Materials |
| 44 | Procedure for Line Clearance |
| 45 | Batch Production/Packing and Control Record Review Procedure |
| 46 | Qualification of Area |
| 47 | Unique Numeric Codification of Printed Packaging Materials |
| 48 | Operation of Vernier Caliper |
| 50 | Safety Instructions for Sampling and Dispensing |
| 51 | Technology Transfer of New Product |
| 52 | Printed Product Label/Carton Control |
| 53 | Handling of Out of Specification (OOS) Results |
| 54 | Product Traceability & Retrieval (Mock Recall) |
| 55 | Approval/Rejection of Raw Material and Packing Material |
| 56 | Management of Stability Studies |
| 57 | Training of Personnel |
| 58 | Qualification of Auditor |
| 59 | Procedure for Preparation, Review and Control of Labels |
| 60 | Passivation |
| 61 | Handling of Glass, Plastic and Sharp Edge Instruments |
| 62 | Quality Risk Management |
| 63 | Introduction of New Product at the Site |
| 64 | Workmen Training |
| 65 | Operation and Cleaning of Reverse Laminar Air Flow (Primary Packing Material) |
| 66 | Storage condition and Period of Storage for Dispensed Raw Materials, In-Process and Finished Products |
| 67 | Contract Agreement Procedure |
| 68 | Monitoring and Compliance of GMP Activities |
| 69 | Acceptable Quality Level |
| 70 | Trend Analysis |
| 71 | GAP Analysis |
| 72 | Preparation, Approval, Control and Revision of Engineering Drawing |
| 73 | Rounding Off the Numerals used for Manufacturing Activities |
| 74 | Procurement, Storage, Usage and Destruction of Stamps |
| 75 | Good Documentation Practices |
| 76 | Procedure for Leak Test (LTA – 300) |
| 77 | Verification and Calibration of Weighing Balance |
| 78 | Procedure for Disposal of Filled Batch Production Control Record (BPCR) |
| 79 | Waste Management |
| 80 | Cleaning, operation and calibration of analytical balance; Make: Shimadzu Model: AUX-220 |
| 81 | Operation and Cleaning Procedure for Humidity Chamber (Make – Newtronic) |
| 82 | Procedure for Handling of Vendor Complaints |
| 93 | Operation of Refrigerator |
| 84 | Handling of Out of Trends |
| 85 | Color Coding |
| 86 | Investigation System |
| 87 | Review of Quality System by Quality Review Steering Committee (QRSC) |
| 88 | Access Control |
| 89 | Contract agreement finalization with outside agencies |
| 90 | PLC Validation |
| 91 | Procedure for placing data logger with export consignment and data retrieval procedure from data logger |
| 92 | Verification of Timer |
| 94 | Monitoring of Temperature and Relative Humidity |
| 95 | Cleaning, Operation and Calibration of Analytical Balance. |
| 96 | Procedure for Cleaning, Operation & Calibration of Tablet Tester |
| 97 | Receipt, Storage, Reconciliation and testing of critical consumables |
| 98 | Numbering System of Non Routine Studies |
| 99 | Tracking of Regulatory Updates |
| 100 | Handling of Market Returns and Repacking of Finished Goods |
| 101 | Reviewer Qualification |
| 102 | Data Integrity |
| 103 | Cleaning, Operation and Calibration of Friability Test Apparatus |
| 104 | Cleaning, Operation and Calibration of Disintegration Tester Make |
| 105 | Cleaning, Operation and Calibration of tablet combination tester Easy check Pro |
| 108 | General Numbering System |
| 109 | Annual Maintenance Contract and Preventive Maintenance of Stability Chambers |
| 110 | Cleaning, Operation and Use of Paper Shredding Machine |
| 111 | Cleaning, Operation and Calibration of Torque Tester |
| 112 | Review of Audit Trial |
| 113 | Registration transfer document RTD Review Procedure |
| 114 | Procedure for Preparation of Transmissible Spongiform Encephalopathy (TSE)/Bovine (BSE) free declaration of the Finished product |
| 115 | Handling of Temperature excursion observed during transit |
| 116 | Re-Processing of batches |
| 117 | Handling of OOS reported by contract giver |
| 118 | Water System performance Review |
| 119 | Handling of Field alert Report |
| 120 | Entry and Exit Procedure for Raw Material Sampling Area |
| 121 | Handling of Audits |
| 122 | Function of Quality Department |
| 123 | Adverse Drug Event |
| 124 | Procedure for Sending of Documents to Contract Giver |
| 125 | Export Consignment Checking Procedure |
| 126 | Issuance Procedure of Master Production/Packing and Control Record (MPCR) and IN process Formats |
| 127 | Computer System management |
| 128 | Temperature Mapping Study |
| 129 | User access and password management |
| 130 | Procedure for Calibration of Instruments through External Agency |
| 131 | Signature Identification for batch production/Packing and Control Record |
| 132 | Generation and Issuance Procedure for Additional Raw/Packing material and Miscellaneous Items |
| 133 | Hazard Analysis and Critical Control Points |
| 134 | Operation Of Minitab 18 |
| 135 | Execution of Qualification protocol and Handling of Validation Deviation |
| 136 | Personnel Qualification of Aseptic Processing Area and Sterility Testing Area |
© 2024 Pharmaceuticals Index. All rights reserved.