Documentation, Record and Polices are the need for Good Manufacturing Practices (GMP) compliance in Pharmaceutical Industry.
Proper documentation and record maintenance is a principal step in Good Manufacturing Practice regulations.
Good documentation is a crucial part of the quality assurance system and is needed in almost every aspect of pharmaceutical manufacturing It aims to provide high degree of assurance that the manufacturing process or quality related activities are carried out in the similar manner as they are planned and approved. It provides procedures or the detailed information regarding the process of manufacturing to the personnel’s concerned with the manufacturing and ensures that the personnel know what to and when to do. Proper record permits to keep track over the manufacturing of particular batch, starting from the receipt of raw materials to the final product release.
“If it’s not written down then it didn’t happen!”
The procedure should be clear, concise and logical. Clearly written procedure or records, prevent the errors that may arise from verbal communication. These procedures should include the formula or detailed description for various operations like manufacturing, processing and packaging of the drug product. A good procedure is that which helps the personnel to understand each and every point written it. Procedures must not be written in technical language that may unable the reader to understand the process and ultimately lead to quality failure.
GXPZONE PHARMA ACADEMY is a perfect platform for all major technical documents used in the pharmaceutical Industry. All these documents may be used as a guidance document for preparing your own documents as per your company’s quality system. All the documents are available from our Document bank and can be downloaded at a very nominal one-time payment. All these documents are updated whenever there is an updation in respective guidelines.
Following major documents are available in our document bank. All the documents are in editable MS word format which can be modified as per individual company requirements.
VALIDATION PROTOCOL
| SNO | Document Title | Document ID | File Format | Cost | Buy |
| 1. | Protocol for Purified Water System (PQ) | GXPVP-001 | MS-Word | 750.00 | Add To Cart |
| 2. | Protocol for Process Validation (Tablets) | GXPVP-002 | MS-Word | 800.00 | Add To Cart |
| 3. | Protocol for Process Validation (Capsules) | GXPVP-003 | MS-Word | 800.00 | Add To Cart |
| 4. | Protocol for Process Validation (Ointment/ Cream) | GXPVP-004 | MS-Word | 700.00 | Add To Cart |
| 5. | Protocol for Process Validation (Liquid) | GXPVP-005 | MS-Word | 700.00 | Add To Cart |
| 6. | Protocol for Process Validation (Aerosols) | GXPVP-006 | MS-Word | 800.00 | Add To Cart |
| 7. | Protocol for Process Validation (Dry Syrup) | GXPVP-007 | MS-Word | 700.00 | Add To Cart |
| 8. | Protocol for Cleaning Validation | GXPVP-008 | MS-Word | 800.00 | Add To Cart |
| 9. | Protocol for HVAC Validation (PQ) | GXPVP-009 | MS-Word | 950.00 | Add To Cart |
| 10. | Protocol for Microbial Limit Test | GXPVP-010 | MS-Word | 799.00 | Add To Cart |
| 11 | Protocol for Sterility Test Validation (Direct Inoculation) | GXPVP-011 | MS-Word | 1299.00 | Add To Cart |
| 12. | Protocol for Sterility Test Validation (Membrane Filtration) | GXPVP-012 | MS-Word | 1299.00 | Add To Cart |
| 13. | Protocol for Media Fill Validation (Dry Powder Injection) | GXPVP-013 | MS-Word | 1299.00 | Add To Cart |
| 14. | Protocol for Media Fill Validation (SVP Injection) | GXPVP-014 | MS-Word | 1299.00 | Add To Cart |
| 15. | Protocol for Media Fill Validation (LVP Injection) | GXPVP-015 | MS-Word | 1299.00 | Add To Cart |
| 16. | Protocol for Autoclave Validation | GXPVP-016 | MS-Word | 900.00 | Add To Cart |
| 17. | Protocol for Disinfectant Validation | GXPVP-017 | MS-Word | 499.00 | Add To Cart |
| 18. | Protocol for Dry Heat Sterilizer Validation (DHS) | GXPVP-018 | MS-Word | 799.00 | Add To Cart |
| 19. | Protocol for Sterilized Sterility Test Media Storage Validation | GXPVP-019 | MS-Word | 550.00 | Add To Cart |
| 20. | Protocol for Sterilized Culture Media Storage Validation | GXPVP-020 | MS-Word | 800.00 | Add To Cart |
| 21. | Protocol for Glassware Cleaning Validation | GXPVP-021 | MS-Word | 399.00 | Add To Cart |
| 22. | Protocol for Hold time Study of Inprocess Samples | GXPVP-022 | MS-Word | 349.00 | Add To Cart |
| 23. | Protocol for Water for injection (WFI) System (PQ) | GXPVP-023 | MS-Word | 550.00 | Add To Cart |
| 24. | Protocol for Bacterial Endotoxin Test Validation | GXPVP-024 | MS-Word | 455.00 | Add To Cart |
QUALITY SYSTEM
| SNO | Document Title | Document ID | File Format | Cost | Buy |
| 1. | Site Master File (SMF) | GXPQS-001 | MS-Word | 1399.00 | Add To Cart |
| 2. | Quality Manual (QM) | GXPQS-002 | MS-Word | 900.00 | Add To Cart |
| 3. | Validation Master Plan (VMP) | GXPQS-003 | MS-Word | 1299.00 | Add To Cart |
| 4. | Process Validation Master Plan (PVMP) | GXPQS-004 | MS-Word | 700.00 | Add To Cart |
| 5. | Computer System Validation Master Plan (CSVMP) | GXPQS-005 | MS-Word | 700.00 | Add To Cart |
| 6. | Calibration Master Plan (CMP) | GXPQS-006 | MS-Word | 600.00 | Add To Cart |
| 7. | Cleaning Validation Master Plan (CVMP) | GXPQS-007 | MS-Word | 800.00 | Add To Cart |
SOP QUALITY ASSURANCE
| SNO | Document Title | Document ID | File Format | Cost | Buy |
| 1. | Preparation, Review, Approval, Control and Revision of Standard Operating Procedures | SOP-QA-01 | MS-Word | 650.00 | Add To Cart |
| 2. | Good Documentation Practices | SOP-QA-02 | MS-Word | 550.00 | Add To Cart |
| 3. | Preparation, Review and Approval of Validation Master Plan | SOP-QA-03 | MS-Word | 500.00 | Add To Cart |
| 4. | Process Validation | SOP-QA-04 | MS-Word | 750.00 | Add To Cart |
| 5. | Document Control Procedure | SOP-QA-05 | MS-Word | 600.00 | Add To Cart |
| 6. | Handling of Deviation | SOP-QA-06 | MS-Word | 750.00 | Add To Cart |
| 7. | Collection, Storage, Review and Destruction of Retain Samples | SOP-QA-07 | MS-Word | 650.00 | Add To Cart |
| 8. | Change Control Procedure | SOP-QA-08 | MS-Word | 750.00 | Add To Cart |
| 9. | Cleaning Validation | SOP-QA-09 | MS-Word | 900.00 | Add To Cart |
| 10. | Self Inspection Procedure | SOP-QA-10 | MS-Word | 900.00 | Add To Cart |
| 11 | Handling of Market Returns | SOP-QA-11 | MS-Word | 650.00 | Add To Cart |
| 12. | Handling of Market Complaint | SOP-QA-12 | MS-Word | 750.00 | Add To Cart |
| 13. | Drug Product Recall | SOP-QA-13 | MS-Word | 700.00 | Add To Cart |
| 14. | Signature Identification | SOP-QA-14 | MS-Word | 500.00 | Add To Cart |
| 15. | Handling of Corrective Action and Preventive Action (CAPA) | SOP-QA-15 | MS-Word | 600.00 | Add To Cart |
| 16. | Preparation, Review and Approval of Equipment, Utilities Qualification Document | SOP-QA-16 | MS-Word | 700.00 | Add To Cart |
| 17. | Handling of Incidence | SOP-QA-17 | MS-Word | 750.00 | Add To Cart |
| 18. | Qualification of Area | SOP-QA-18 | MS-Word | 700.00 | Add To Cart |
| 19. | Technology Transfer of New Product | SOP-QA-19 | MS-Word | 800.00 | Add To Cart |
| 20. | Handling of Out of Specification (OOS) Results | SOP-QA-20 | MS-Word | 850.00 | Add To Cart |
| 21. | Management of Stability Studies | SOP-QA-21 | MS-Word | 900.00 | Add To Cart |
| 22. | Product Traceability & Retrieval (Mock Recall) | SOP-QA-22 | MS-Word | 650.00 | Add To Cart |
| 23. | Risk Analysis | SOP-QA-23 | MS-Word | 850.00 | Add To Cart |
| 24. | Qualification of Auditor | SOP-QA-24 | MS-Word | 600.00 | Add To Cart |
| 25. | Handling of Out of Trend Results | SOP-QA-25 | MS-Word | 700.00 | Add To Cart |
| 26. | Tracking of Regulatory Updates | SOP-QA-26 | MS-Word | 650.00 | Add To Cart |
| 27. | Qualification of Contract Analytical Laboratory | SOP-QA-27 | MS-Word | 550.00 | Add To Cart |
| 28. | Rounding Off the Numerals used for Manufacturing Activities | SOP-QA-28 | MS-Word | 650.00 | Add To Cart |
| 29. | Online Rejection of Raw Materials and Packing Materials | SOP-QA-29 | MS-Word | 700.00 | Add To Cart |
| 30. | Passivation | SOP-QA-30 | MS-Word | 500.00 | Add To Cart |
| 31. | Execution of Pharmacopoeial Changes | SOP-QA-31 | MS-Word | 800.00 | Add To Cart |
| 32. | Preparation of Calibration Manual | SOP-QA-32 | MS-Word | 700.00 | Add To Cart |
SOP QUALITY CONTROL
| SNO | Document Title | Document ID | File Format | Cost | Buy |
| 1. | Good Laboratory Practices | SOP-QC-01 | MS-Word | 800.00 | Add To Cart |
| 2. | Sample Tracing and Release / Reject Procedure for Raw Material | SOP-QC-02 | MS-Word | 700.00 | Add To Cart |
| 3. | Calibration of Quality Control Instruments | SOP-QC-03 | MS-Word | 850.00 | Add To Cart |
| 4. | Annual Maintenance Contract and Preventive Maintenance of Laboratory Instruments | SOP-QC-04 | MS-Word | 800.00 | Add To Cart |
| 5. | Preparation of Volumetric Solutions and Test Reagents | SOP-QC-05 | MS-Word | 750.00 | Add To Cart |
| 6. | Preparation of Specifications, Methods of Analysis and Standard Test Procedures | SOP-QC-06 | MS-Word | 700.00 | Add To Cart |
| 7. | Qualification of Analyst for Analytical Techniques | SOP-QC-07 | MS-Word | 850.00 | Add To Cart |
| 8. | Sample Tracing and Release / Reject Procedure for In-process / Finished Product | SOP-QC-08 | MS-Word | 800.00 | Add To Cart |
| 9. | Training Programme for Quality Control Personnel | SOP-QC-09 | MS-Word | 700.00 | Add To Cart |
| 10. | Handling of Reference Standard and Preparation of Working Standard | SOP-QC-10 | MS-Word | 900.00 | Add To Cart |
| 11 | Analytical Method Validation | SOP-QC-11 | MS-Word | 900.00 | Add To Cart |
| 12. | Determination of Shelf Life Period of Volumetric Solutions | SOP-QC-12 | MS-Word | 750.00 | Add To Cart |
| 13. | Handling of Out of Calibration (OOC) Results | SOP-QC-13 | MS-Word | 600.00 | Add To Cart |
| 14. | Rounding Off Procedure for Analytical Numeric Values | SOP-QC-14 | MS-Word | 650.00 | Add To Cart |
| 15. | Column Management | SOP-QC-15 | MS-Word | 800.00 | Add To Cart |
| 16. | Handling of Laboratory Incidents | SOP-QC-16 | MS-Word | 850.00 | Add To Cart |
| 17. | Chromatographic Practices | SOP-QC-17 | MS-Word | 900.00 | Add To Cart |
| 18. | Sample management in Quality Control lab | SOP-QC-18 | MS-Word | 700.00 | Add To Cart |
| 19. | Trending and Monitoring Effectiveness of Analyst performance | SOP-QC-19 | MS-Word | 600.00 | Add To Cart |
| 20. | Review of Audit trials | SOP-QC-20 | MS-Word | 750.00 | Add To Cart |
| 21. | Sampling of Raw materials | SOP-QC-21 | MS-Word | 800.00 | Add To Cart |
| 22. | Receiving and Storage of chemicals and solvents | SOP-QC-22 | MS-Word | 600.00 | Add To Cart |
| 23. | Retesting of Raw materials | SOP-QC-23 | MS-Word | 700.00 | Add To Cart |
| 24. | Preparation and Storage of Mobile phase | SOP-QC-24 | MS-Word | 550.00 | Add To Cart |
SOP MICROBIOLOGY
| SNO | Document Title | Document ID | File Format | Cost | Buy |
| 1. | Good microbiological laboratory practices | SOP-MB-01 | MS-Word | 700.00 | Add To Cart |
| 2. | Maintenance and Sub Culturing of Pure Cultures and Environment Isolates | SOP-MB-02 | MS-Word | 700.00 | Add To Cart |
| 3. | Sampling and Testing of Raw Water, Potable water, Process Water, Soft Water, Purified water and DM Water | SOP-MB-03 | MS-Word | 650.00 | Add To Cart |
| 4. | Disposal of Contaminated Materials and Cleaning of Contaminated Glassware | SOP-MB-04 | MS-Word | 700.00 | Add To Cart |
| 5. | Preparation and Sterilization of Medium for Specified Microorganisms | SOP-MB-05 | MS-Word | 650.00 | Add To Cart |
| 6. | Preparation and Sterilization of Medium for Total Viable Aerobic Count and Environmental Monitoring new | SOP-MB-06 | MS-Word | 700.00 | Add To Cart |
| 7. | Enumeration of Total Viable Spore Count in Biological Indicators | SOP-MB-07 | MS-Word | 750.00 | Add To Cart |
| 8. | Handling of Out of Specification Results in Microbiological Testing | SOP-MB-08 | MS-Word | 800.00 | Add To Cart |
| 9. | Procedure fumigation and defumigation | SOP-MB-09 | MS-Word | 700.00 | Add To Cart |
| 10. | Determination of Total Viable Aerobic Count in Raw materials, Semi-finished & Finished Products | SOP-MB-10 | MS-Word | 700.00 | Add To Cart |
| 11 | Bioburden Determination of Compressed Nitrogen Gas | SOP-MB-11 | MS-Word | 800.00 | Add To Cart |
| 12. | Environmental monitoring of non-sterile area by active and passive air sampling | SOP-MB-12 | MS-Word | 750.00 | Add To Cart |
| 13. | Growth Promotion Test and Preparation of Culture Suspension | SOP-MB-13 | MS-Word | 600.00 | Add To Cart |
| 14. | Entry and Exit Procedure in Microbiology | SOP-MB-14 | MS-Word | 650.00 | Add To Cart |
| 15. | Receiving and Storage of Dehydrated Medium | SOP-MB-15 | MS-Word | 800.00 | Add To Cart |
| 16. | Microbial Monitoring of Linen | SOP-MB-16 | MS-Word | 650.00 | Add To Cart |
| 17. | Bioburden Determination of Compressed Air | SOP-MB-17 | MS-Word | 700.00 | Add To Cart |
| 18. | Handling of Out of Trend Results in Environmental Monitoring and Water Analysis | SOP-MB-18 | MS-Word | 700.00 | Add To Cart |
| 19. | Validation Procedure for Checking Efficacy of Disinfectant and Cleaning Procedure | SOP-MB-19 | MS-Word | 600.00 | Add To Cart |
| 20. | Identification and Isolate of Micro-organisms | SOP-MB-20 | MS-Word | 750.00 | Add To Cart |
SOP HR
| SNO | Document Title | Document ID | File Format | Cost | Buy |
| 1. | Accident handling and action at factory premises | SOP-HR-01 | MS-Word | 700.00 | Add To Cart |
| 2. | Washing issuance and maintenance of linen | SOP-HR-02 | MS-Word | 500.00 | Add To Cart |
| 3. | Security Checks | SOP-HR-03 | MS-Word | 650.00 | Add To Cart |
| 4. | Recruitment of Technician and workmen. | SOP-HR-04 | MS-Word | 700.00 | Add To Cart |
| 5. | Pre employment and periodic medical check up | SOP-HR-05 | MS-Word | 650.00 | Add To Cart |
| 6. | Personal Health & hygiene. | SOP-HR-06 | MS-Word | 500.00 | Add To Cart |
| 7. | Operation, cleaning & inspection of insectocutor. | SOP-HR-07 | MS-Word | 450.00 | Add To Cart |
| 8. | Material management. | SOP-HR-08 | MS-Word | 700.00 | Add To Cart |
| 9. | Integrated Pest Management services. | SOP-HR-09 | MS-Word | 550.00 | Add To Cart |
| 10. | Key Deposition and issuance procedure. | SOP-HR-10 | MS-Word | 400.00 | Add To Cart |
| 11 | Internal and external mail movement. | SOP-HR-11 | MS-Word | 500.00 | Add To Cart |
| 12. | Footware cleaning and Sanitization. | SOP-HR-12 | MS-Word | 650.00 | Add To Cart |
| 13. | First Aid appliance and training. | SOP-HR-13 | MS-Word | 500.00 | Add To Cart |
| 14. | Entry Exit procedure . | SOP-HR-14 | MS-Word | 550.00 | Add To Cart |
| 15. | Cleaning of Drain Chambers | SOP-HR-15 | MS-Word | 500.00 | Add To Cart |
| 16. | Scrap Disposal | SOP-HR-16 | MS-Word | 650.00 | Add To Cart |
SOP ENGINEERING
| SNO | Document Title | Document ID | File Format | Cost | Buy |
| 1. | Operation and Sanitization of Purified Water Plant | SOP-EN-01 | MS-Word | 700.00 | Add To Cart |
| 2. | Power Failure Management | SOP-EN-02 | MS-Word | 700.00 | Add To Cart |
| 3. | Procedure for Calibration of Instruments by Out Side Agencies | SOP-EN-03 | MS-Word | 650.00 | Add To Cart |
| 4. | Procedure for Building Maintenance | SOP-EN-04 | MS-Word | 700.00 | Add To Cart |
| 5. | Procedure to Attend Break Down | SOP-EN-05 | MS-Word | 650.00 | Add To Cart |
| 6. | Procedure for Colour Coding of Utility Line | SOP-EN-06 | MS-Word | 500.00 | Add To Cart |
| 7. | Preventive Maintenance Programme | SOP-EN-07 | MS-Word | 650.00 | Add To Cart |
| 8. | Preventive Maintenance of Purified Water System | SOP-EN-08 | MS-Word | 800.00 | Add To Cart |
| 9. | Preventive Maintenance of Effluent Treatment Plant | SOP-EN-09 | MS-Word | 600.00 | Add To Cart |
| 10. | Maintaining the Machine History Card | SOP-EN-10 | MS-Word | 400.00 | Add To Cart |
| 11 | Cleaning and Preventive Maintenance of Filter Cleaning Booth | SOP-EN-11 | MS-Word | 500.00 | Add To Cart |
| 12. | Procedure for Monitoring of Luminance and Noise Level in Working Area | SOP-EN-12 | MS-Word | 650.00 | Add To Cart |
| 13. | Temperature and Relative Humidity Monitoring in Production / Warehouse area | SOP-EN-13 | MS-Word | 500.00 | Add To Cart |
| 14. | Challenge Test for Dumping Valve in Operation of Purified Water System | SOP-EN-14 | MS-Word | 550.00 | Add To Cart |
| 15. | Time verification and correction against GPS synchronized clock | SOP-EN-15 | MS-Word | 800.00 | Add To Cart |
| 16. | System access control procedure for manufacturing and utility equipments | SOP-EN-16 | MS-Word | 650.00 | Add To Cart |
| 17. | Alarm Management | SOP-EN-17 | MS-Word | 500.00 | Add To Cart |
| 18. | Procedure for power change over | SOP-EN-18 | MS-Word | 600.00 | Add To Cart |
| 19. | Receipt, Testing, Storage and handling of chemicals | SOP-EN-19 | MS-Word | 500.00 | Add To Cart |
| 20. | Preventive maintenance & challenge test of UPS | SOP-EN-20 | MS-Word | 450.00 | Add To Cart |