Editable Quality Assurance SOP Free Download
Editable Quality Assurance SOP Free Download
Welcome to “Editable Quality Assurance SOP,” your premier source for pharmaceutical manufacturing SOPs tailored for the quality assurance department. Our blog provides editable SOPs designed to meet the stringent standards of the pharmaceutical industry. Stay informed with the latest regulatory updates, best practices, and expert guidance to ensure your quality assurance processes are compliant, efficient, and effective. Join us in achieving excellence in pharmaceutical manufacturing.
Editable Quality Assurance SOP:
|
S. No. |
SOP No. | SOP Title |
Click to Download |
| 1 | QA001 | SOP ON SOP | |
| 2 | QA002 | Format Issuance and Control | |
| 3 | QA003 | Change Control System | |
| 4 | QA004 | Deviation control | |
| 5 | QA005 | Training of Plant Personnel | |
| 6 | QA006 | Site Master File | |
| 7 | QA007 | Preparation of General Test Procedures | |
| 8 | QA008 | Validation of equipments / instruments / system / process / method. | |
| 9 | QA009 | Procedure For Issuance of BMR &BPR in Production Department | |
| 10 | QA010 |
Batch Numbering System |
|
| 11 |
QA011 |
Initiation and execution of stability studies | |
| 12 | QA012 | Investigation Of Laboratory Failure Results During Stability Studies | |
| 13 | QA013 | Validation Master Plan | |
| 14 | QA014 | Preparation and Control of product Manual, Batch Manufacturing Record (BMR)and Batch Packing Record(BPR) | |
| 15 | QA015 | Procedure for Review of BMR&BPR | |
| 16 | QA016 | Job Responsibilities | |
| 17 | QA017 | Procedure for Documentation & Recording In Quality Assurance | |
| 18 | QA018 | Preparation , Issuance & Retrieval of Analytical Test Data Sheets | |
| 19 | QA019 | Batch Release | |
| 20 | QA020 | Annual Product Review | |
| 21 | QA021 | Handling Of Rejected Material | |
| 22 | QA022 | Handling Of Returned Goods | |
| 23 | QA023 | Procedure For Handling Of Out Of Specification Results | |
| 24 | QA024 |
Documents Storage Period |
|
| 25 | QA025 | Procedure For Expiry Date | |
| 26 | QA026 | Assigning code numbers to Raw material, Packing material and Finished products | |
| 27 | QA027 | Self Inspection | |
| 28 | QA028 | Review Of Documents | |
| 29 | QA029 | Equipment Numbering System | |
| 30 | QA030 | Personnel Qualification | |
| 31 | QA031 | Corrective & Preventive Action For Non-Conforming Results in Total Microbial Count in Water Samples | |
| 32 | QA032 | Investigations | |
| 33 | QA033 |
Authorized Signatories |
|
| 34 | QA034 | Procedure for Validation Criteria | |
| 35 | QA035 | To Make Correction In Records | |
| 36 | QA036 |
Handling Of Market Complaints |
|
| 37 | QA037 | Investigation Of Non-conforming Material | |
| 38 | QA038 | Non-Conforming Material Review & Disposition | |
| 39 | QA039 | Preparation Of Art Works | |
| 40 | QA040 | Vendor Qualification | |
| 41 | QA041 | Sampling Of In Process and Finished Drug Product | |
| 42 | QA042 |
Disinfectant Usage Policy |
|
| 43 | QA043 | Control Of Product Labels | |
| 44 | QA044 | Handling And Control Of Drawings / Schematic Layouts | |
| 45 | QA045 | Procedure For Product Recall | |
| 46 | QA046 | Corrective & Preventive action for Non-conforming results in Microbiological Environmental Monitoring | |
| 47 | QA047 | Procedure For Batch Record Docket Archival | |
| 48 | QA048 | Common Vendor Qualification & Approval for Packing Material | |
| 49 | QA049 | Procedure For Sampling And Analysis Of Water Sample After Cleaning | |
| 50 | QA050 | Preparation and control of Master formula record | |
| 51 | QA051 | Procedure for Sampling of Finished Product | |
| 52 | QA052 | Sampling of IN-Process Samples | |
| 53 | QA053 | Analysis and Release of Finished Product Samples. | |
| 54 | QA054 | Line Clearance Procedure for Manufacturing and Packing Operation |
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