SOP ToolBox - Pharmaceutical Preparation Manufacturing

Pharmaceutical Preparation Manufacturing is a highly regulated industry dedicated to producing safe, effective, and high-quality medicines. It involves complex processes such as formulation, blending, filling, and packaging, all of which must meet stringent global regulatory standards. Consistency, accuracy, and compliance are paramount to ensure product quality and patient safety.

Standard Operating Procedures (SOPs) play a critical role in maintaining these standards. SOPs are step-by-step instructions that ensure operations are performed consistently and correctly, reducing errors, enhancing efficiency, and ensuring compliance with Good Manufacturing Practices (GMP). For manufacturers, SOPs are vital for achieving regulatory compliance, avoiding costly penalties, and fostering continuous improvement in operations.

Our comprehensive library of 500 recommended SOPs is designed to streamline your manufacturing processes, improve training and staff performance, and reduce risks. These SOPs cover every aspect of pharmaceutical preparation, including quality control, equipment maintenance, documentation, safety protocols, and more. By implementing well-crafted SOPs, you can strengthen your operations, maintain regulatory compliance, and enhance product quality—all while ensuring patient safety remains a top priority.

For enquiries, please write to us at Consulting@Fhyzics.net

SOP-PPM-001: Standard Operating Procedure for Raw Material Receipt and Inspection
SOP-PPM-002: Standard Operating Procedure for Raw Material Storage
SOP-PPM-003: Standard Operating Procedure for Weighing and Dispensing of Raw Materials
SOP-PPM-004: Standard Operating Procedure for Cleaning and Sanitization of Manufacturing Area
SOP-PPM-005: Standard Operating Procedure for Equipment Calibration and Maintenance
SOP-PPM-006: Standard Operating Procedure for Equipment Cleaning and Verification
SOP-PPM-007: Standard Operating Procedure for Batch Manufacturing Record Preparation
SOP-PPM-008: Standard Operating Procedure for Granulation Process
SOP-PPM-009: Standard Operating Procedure for Blending Process
SOP-PPM-010: Standard Operating Procedure for Tablet Compression
SOP-PPM-011: Standard Operating Procedure for Capsule Filling
SOP-PPM-012: Standard Operating Procedure for Coating Process
SOP-PPM-013: Standard Operating Procedure for Sterilization of Equipment and Materials
SOP-PPM-014: Standard Operating Procedure for Aseptic Filling
SOP-PPM-015: Standard Operating Procedure for Lyophilization (Freeze Drying)
SOP-PPM-016: Standard Operating Procedure for Visual Inspection of Sterile Products
SOP-PPM-017: Standard Operating Procedure for Packaging and Labeling
SOP-PPM-018: Standard Operating Procedure for Handling and Storage of Finished Products
SOP-PPM-019: Standard Operating Procedure for Stability Testing
SOP-PPM-020: Standard Operating Procedure for Environmental Monitoring
SOP-PPM-021: Standard Operating Procedure for Microbiological Testing
SOP-PPM-022: Standard Operating Procedure for Sampling of Raw Materials and Finished Products
SOP-PPM-023: Standard Operating Procedure for Water System Monitoring and Maintenance
SOP-PPM-024: Standard Operating Procedure for Handling Deviations and NonConformances
SOP-PPM-025: Standard Operating Procedure for Corrective and Preventive Actions (CAPA)
SOP-PPM-026: Standard Operating Procedure for Change Control Management
SOP-PPM-027: Standard Operating Procedure for Documentation and Record Management
SOP-PPM-028: Standard Operating Procedure for Qualification and Validation of Equipment
SOP-PPM-029: Standard Operating Procedure for Cleaning Validation
SOP-PPM-030: Standard Operating Procedure for Process Validation
SOP-PPM-031: Standard Operating Procedure for Analytical Method Validation
SOP-PPM-032: Standard Operating Procedure for Internal Audits
SOP-PPM-033: Standard Operating Procedure for Supplier Qualification and Management
SOP-PPM-034: Standard Operating Procedure for Handling of Complaints
SOP-PPM-035: Standard Operating Procedure for Recall of Products
SOP-PPM-036: Standard Operating Procedure for Product Development
SOP-PPM-037: Standard Operating Procedure for Scale-Up and Technology Transfer
SOP-PPM-038: Standard Operating Procedure for Training and Competency Assessment
SOP-PPM-039: Standard Operating Procedure for Safety and Personal Protective Equipment (PPE)
SOP-PPM-040: Standard Operating Procedure for Waste Management
SOP-PPM-041: Standard Operating Procedure for Disposal of Hazardous Waste
SOP-PPM-042: Standard Operating Procedure for Handling and Storage of Controlled Substances
SOP-PPM-043: Standard Operating Procedure for Utility System Maintenance (HVAC, Compressed Air)
SOP-PPM-044: Standard Operating Procedure for Handling of Returned Goods
SOP-PPM-045: Standard Operating Procedure for Preventive Maintenance Program
SOP-PPM-046: Standard Operating Procedure for Pest Control Management
SOP-PPM-047: Standard Operating Procedure for Preparation of Standard Solutions
SOP-PPM-048: Standard Operating Procedure for Good Documentation Practices (GDP)
SOP-PPM-049: Standard Operating Procedure for Media Fill Trials (Aseptic Processes)
SOP-PPM-050: Standard Operating Procedure for Filter Integrity Testing
SOP-PPM-051: Standard Operating Procedure for Cleaning and Disinfection of Isolators
SOP-PPM-052: Standard Operating Procedure for In-Process Controls
SOP-PPM-053: Standard Operating Procedure for Sterility Testing
SOP-PPM-054: Standard Operating Procedure for Endotoxin Testing
SOP-PPM-055: Standard Operating Procedure for Microbial Limits Testing
SOP-PPM-056: Standard Operating Procedure for pH and Conductivity Testing
SOP-PPM-057: Standard Operating Procedure for HPLC Analysis
SOP-PPM-058: Standard Operating Procedure for Gas Chromatography (GC) Analysis
SOP-PPM-059: Standard Operating Procedure for UV-Vis Spectrophotometry
SOP-PPM-060: Standard Operating Procedure for Infrared (IR) Spectroscopy
SOP-PPM-061: Standard Operating Procedure for Dissolution Testing
SOP-PPM-062: Standard Operating Procedure for Particle Size Analysis
SOP-PPM-063: Standard Operating Procedure for Karl Fischer Titration
SOP-PPM-064: Standard Operating Procedure for Assay by Titration
SOP-PPM-065: Standard Operating Procedure for Visual Inspection of Packaging
SOP-PPM-066: Standard Operating Procedure for Blister Packaging Operations
SOP-PPM-067: Standard Operating Procedure for Strip Packaging Operations
SOP-PPM-068: Standard Operating Procedure for Bottle Filling and Capping
SOP-PPM-069: Standard Operating Procedure for Label Printing and Reconciliation
SOP-PPM-070: Standard Operating Procedure for Barcode Verification
SOP-PPM-071: Standard Operating Procedure for Cold Chain Management
SOP-PPM-072: Standard Operating Procedure for Temperature and Humidity Monitoring
SOP-PPM-073: Standard Operating Procedure for Control of Microbial Contamination
SOP-PPM-074: Standard Operating Procedure for Gowning and Entry to Cleanrooms
SOP-PPM-075: Standard Operating Procedure for Cleanroom Behavior and Practices
SOP-PPM-076: Standard Operating Procedure for Air Handling Unit (AHU) Operation
SOP-PPM-077: Standard Operating Procedure for HEPA Filter Integrity Testing
SOP-PPM-078: Standard Operating Procedure for Cleanroom Classification and Requalification
SOP-PPM-079: Standard Operating Procedure for Environmental Impact Assessment
SOP-PPM-080: Standard Operating Procedure for Laboratory Instrument Calibration
SOP-PPM-081: Standard Operating Procedure for Out-of-Specification (OOS) Investigations
SOP-PPM-082: Standard Operating Procedure for Out-of-Trend (OOT) Investigations
SOP-PPM-083: Standard Operating Procedure for Handling of Reference Standards
SOP-PPM-084: Standard Operating Procedure for Preparation and Storage of Reagents
SOP-PPM-085: Standard Operating Procedure for Cleaning and Maintenance of Balances
SOP-PPM-086: Standard Operating Procedure for Control of Analytical Data
SOP-PPM-087: Standard Operating Procedure for Backup and Archival of Laboratory Data
SOP-PPM-088: Standard Operating Procedure for Requalification of Laboratory Instruments
SOP-PPM-089: Standard Operating Procedure for Training in Laboratory Safety
SOP-PPM-090: Standard Operating Procedure for Laboratory Waste Disposal
SOP-PPM-091: Standard Operating Procedure for Preparation of Stability Protocols
SOP-PPM-092: Standard Operating Procedure for Stability Chamber Monitoring
SOP-PPM-093: Standard Operating Procedure for Data Integrity Compliance
SOP-PPM-094: Standard Operating Procedure for Water for Injection (WFI) System Operation
SOP-PPM-095: Standard Operating Procedure for Clean Steam System Operation
SOP-PPM-096: Standard Operating Procedure for Compressed Air System Monitoring
SOP-PPM-097: Standard Operating Procedure for Nitrogen System Operation
SOP-PPM-098: Standard Operating Procedure for Deviation Handling in Manufacturing
SOP-PPM-099: Standard Operating Procedure for Risk Assessment and Mitigation
SOP-PPM-100: Standard Operating Procedure for Emergency Preparedness and Response
SOP-PPM-101: Standard Operating Procedure for Investigation of Product Complaints
SOP-PPM-102: Standard Operating Procedure for Market Recall Procedures
SOP-PPM-103: Standard Operating Procedure for Product Quarantine and Release
SOP-PPM-104: Standard Operating Procedure for Document Control System
SOP-PPM-105: Standard Operating Procedure for Master Formula Preparation
SOP-PPM-106: Standard Operating Procedure for Annual Product Quality Review (APQR)
SOP-PPM-107: Standard Operating Procedure for Batch Numbering System
SOP-PPM-108: Standard Operating Procedure for Finished Product Release
SOP-PPM-109: Standard Operating Procedure for Stability Sample Management
SOP-PPM-110: Standard Operating Procedure for Retention Sample Management
SOP-PPM-111: Standard Operating Procedure for HVAC System Maintenance
SOP-PPM-112: Standard Operating Procedure for Utility Qualification
SOP-PPM-113: Standard Operating Procedure for Manufacturing Process Optimization
SOP-PPM-114: Standard Operating Procedure for Cleaning of Glassware
SOP-PPM-115: Standard Operating Procedure for pH Meter Calibration and Use
SOP-PPM-116: Standard Operating Procedure for Conductivity Meter Calibration
SOP-PPM-117: Standard Operating Procedure for Water Sampling and Testing
SOP-PPM-118: Standard Operating Procedure for Cleaning and Maintenance of HPLC Systems
SOP-PPM-119: Standard Operating Procedure for Handling Cytotoxic Drugs
SOP-PPM-120: Standard Operating Procedure for Manufacturing of Oral Solid Dosage Forms
SOP-PPM-121: Standard Operating Procedure for Manufacturing of Oral Liquid Dosage Forms
SOP-PPM-122: Standard Operating Procedure for Manufacturing of Parenteral Preparations
SOP-PPM-123: Standard Operating Procedure for Manufacturing of Ophthalmic Preparations
SOP-PPM-124: Standard Operating Procedure for Manufacturing of Topical Preparations
SOP-PPM-125: Standard Operating Procedure for Dispensing Controlled Substances
SOP-PPM-126: Standard Operating Procedure for Capsule Printing and Inspection
SOP-PPM-127: Standard Operating Procedure for Visual Inspection of Injectable Products
SOP-PPM-128: Standard Operating Procedure for Cleaning Validation Sampling
SOP-PPM-129: Standard Operating Procedure for Product Transfer Between Facilities
SOP-PPM-130: Standard Operating Procedure for Risk Management in Manufacturing
SOP-PPM-131: Standard Operating Procedure for Quality Risk Management (QRM)
SOP-PPM-132: Standard Operating Procedure for Conducting Quality Audits
SOP-PPM-133: Standard Operating Procedure for Supplier Qualification Audits
SOP-PPM-134: Standard Operating Procedure for Inventory Management
SOP-PPM-135: Standard Operating Procedure for Warehouse Management
SOP-PPM-136: Standard Operating Procedure for Cold Storage Monitoring
SOP-PPM-137: Standard Operating Procedure for Handling Expired Materials
SOP-PPM-138: Standard Operating Procedure for Reworking and Reprocessing
SOP-PPM-139: Standard Operating Procedure for Artwork Control and Approval
SOP-PPM-140: Standard Operating Procedure for Quality Control Sample Management
SOP-PPM-141: Standard Operating Procedure for Water for Injection Sampling
SOP-PPM-142: Standard Operating Procedure for Equipment Breakdown Handling
SOP-PPM-143: Standard Operating Procedure for Safety Incident Reporting
SOP-PPM-144: Standard Operating Procedure for Health and Safety Training
SOP-PPM-145: Standard Operating Procedure for Use of Autoclaves
SOP-PPM-146: Standard Operating Procedure for Laminar Air Flow Maintenance
SOP-PPM-147: Standard Operating Procedure for Filter Replacement
SOP-PPM-148: Standard Operating Procedure for Steam Sterilization
SOP-PPM-149: Standard Operating Procedure for Biological Indicators in Sterilization
SOP-PPM-150: Standard Operating Procedure for Preventive Maintenance of Laboratory Equipment
SOP-PPM-151: Standard Operating Procedure for UV Light Intensity Monitoring
SOP-PPM-152: Standard Operating Procedure for Glassware Washing and Sterilization
SOP-PPM-153: Standard Operating Procedure for Media Preparation for Microbiology
SOP-PPM-154: Standard Operating Procedure for Bioburden Testing
SOP-PPM-155: Standard Operating Procedure for Mycoplasma Testing
SOP-PPM-156: Standard Operating Procedure for Viral Contamination Testing
SOP-PPM-157: Standard Operating Procedure for Quality Control of Excipients
SOP-PPM-158: Standard Operating Procedure for API Testing
SOP-PPM-159: Standard Operating Procedure for Out-of-Control (OOC) Investigations
SOP-PPM-160: Standard Operating Procedure for End-Product Testing
SOP-PPM-161: Standard Operating Procedure for Identification of Unknown Substances
SOP-PPM-162: Standard Operating Procedure for Labeling and Packaging Quality Control
SOP-PPM-163: Standard Operating Procedure for Packaging Material Inspection
SOP-PPM-164: Standard Operating Procedure for Preparation of Cleaning Logs
SOP-PPM-165: Standard Operating Procedure for Preventive Maintenance Documentation
SOP-PPM-166: Standard Operating Procedure for Routine Environmental Monitoring
SOP-PPM-167: Standard Operating Procedure for HVAC Filter Replacement
SOP-PPM-168: Standard Operating Procedure for Control of Microbiological Contamination in Cleanrooms
SOP-PPM-169: Standard Operating Procedure for Compressed Gas System Operation
SOP-PPM-170: Standard Operating Procedure for Personal Hygiene in Manufacturing Areas
SOP-PPM-171: Standard Operating Procedure for Electronic Data Backup
SOP-PPM-172: Standard Operating Procedure for Cybersecurity in Pharmaceutical Manufacturing
SOP-PPM-173: Standard Operating Procedure for Periodic Product Review
SOP-PPM-174: Standard Operating Procedure for Self-Inspection
SOP-PPM-175: Standard Operating Procedure for Validation Master Plan Preparation
SOP-PPM-176: Standard Operating Procedure for Protocol Preparation and Approval
SOP-PPM-177: Standard Operating Procedure for Computerized System Validation
SOP-PPM-178: Standard Operating Procedure for Automated System Operation
SOP-PPM-179: Standard Operating Procedure for Data Review and Approval
SOP-PPM-180: Standard Operating Procedure for Root Cause Analysis
SOP-PPM-181: Standard Operating Procedure for Product Yield Calculation
SOP-PPM-182: Standard Operating Procedure for Handling Spillage in Clean Areas
SOP-PPM-183: Standard Operating Procedure for Calibration of Thermometers and Hygrometers
SOP-PPM-184: Standard Operating Procedure for Use of Analytical Balances
SOP-PPM-185: Standard Operating Procedure for Sample Receipt and Registration
SOP-PPM-186: Standard Operating Procedure for Preparation of Test Reports
SOP-PPM-187: Standard Operating Procedure for Deviations in Analytical Testing
SOP-PPM-188: Standard Operating Procedure for Trending Analytical Results
SOP-PPM-189: Standard Operating Procedure for Trending Environmental Monitoring Results
SOP-PPM-190: Standard Operating Procedure for Trending Water System Results
SOP-PPM-191: Standard Operating Procedure for Facility Cleaning and Sanitization
SOP-PPM-192: Standard Operating Procedure for Quality Control of Packaging Components
SOP-PPM-193: Standard Operating Procedure for Control of Reference Samples
SOP-PPM-194: Standard Operating Procedure for Annual Calibration Schedule Preparation
SOP-PPM-195: Standard Operating Procedure for Use of Stability Chambers
SOP-PPM-196: Standard Operating Procedure for Line Clearance in Manufacturing
SOP-PPM-197: Standard Operating Procedure for Cleaning Between Batches
SOP-PPM-198: Standard Operating Procedure for Handling Power Failures
SOP-PPM-199: Standard Operating Procedure for Emergency Shutdown Procedures
SOP-PPM-200: Standard Operating Procedure for Fire Safety and Evacuation
SOP-PPM-201: Standard Operating Procedure for Spill Response and Cleanup
SOP-PPM-202: Standard Operating Procedure for Handling of Hazardous Chemicals
SOP-PPM-203: Standard Operating Procedure for Calibration of Pressure Gauges
SOP-PPM-204: Standard Operating Procedure for Calibration of Weighing Balances
SOP-PPM-205: Standard Operating Procedure for Calibration of pH Meters
SOP-PPM-206: Standard Operating Procedure for Preventive Maintenance of HVAC Systems
SOP-PPM-207: Standard Operating Procedure for Inspection of Incoming Raw Materials
SOP-PPM-208: Standard Operating Procedure for Inspection of Packaging Materials
SOP-PPM-209: Standard Operating Procedure for Sampling Techniques in Quality Control
SOP-PPM-210: Standard Operating Procedure for Stability Study Management
SOP-PPM-211: Standard Operating Procedure for Preparation of Quality Control Reports
SOP-PPM-212: Standard Operating Procedure for Quality Assurance in Batch Release
SOP-PPM-213: Standard Operating Procedure for Line Clearance in Packaging
SOP-PPM-214: Standard Operating Procedure for Equipment Logbook Management
SOP-PPM-215: Standard Operating Procedure for Electronic Batch Records
SOP-PPM-216: Standard Operating Procedure for Good Warehousing Practices (GWP)
SOP-PPM-217: Standard Operating Procedure for Reconciliation of Batch Records
SOP-PPM-218: Standard Operating Procedure for Label Reconciliation
SOP-PPM-219: Standard Operating Procedure for Change Control Evaluation
SOP-PPM-220: Standard Operating Procedure for Quality Review Board (QRB) Meetings
SOP-PPM-221: Standard Operating Procedure for Regulatory Compliance Audits
SOP-PPM-222: Standard Operating Procedure for Recall Effectiveness Checks
SOP-PPM-223: Standard Operating Procedure for Temperature Mapping of Storage Areas
SOP-PPM-224: Standard Operating Procedure for Cold Chain Validation
SOP-PPM-225: Standard Operating Procedure for Equipment Installation Qualification (IQ)
SOP-PPM-226: Standard Operating Procedure for Equipment Operational Qualification (OQ)
SOP-PPM-227: Standard Operating Procedure for Equipment Performance Qualification (PQ)
SOP-PPM-228: Standard Operating Procedure for Filter Validation
SOP-PPM-229: Standard Operating Procedure for Process Simulation Studies
SOP-PPM-230: Standard Operating Procedure for Media Fill Validation
SOP-PPM-231: Standard Operating Procedure for HVAC Qualification
SOP-PPM-232: Standard Operating Procedure for Water System Qualification
SOP-PPM-233: Standard Operating Procedure for Cleaning Equipment Logs
SOP-PPM-234: Standard Operating Procedure for Cross-Contamination Prevention
SOP-PPM-235: Standard Operating Procedure for Manufacturing Area Monitoring
SOP-PPM-236: Standard Operating Procedure for Dispensing and Weighing of Raw Materials
SOP-PPM-237: Standard Operating Procedure for Handling Broken Glass in Cleanrooms
SOP-PPM-238: Standard Operating Procedure for Disposal of Expired Materials
SOP-PPM-239: Standard Operating Procedure for Visual Inspection of Ampoules and Vials
SOP-PPM-240: Standard Operating Procedure for Handling and Maintenance of Syringe Filters
SOP-PPM-241: Standard Operating Procedure for Particle Count Monitoring
SOP-PPM-242: Standard Operating Procedure for Preparation of Reference Standards
SOP-PPM-243: Standard Operating Procedure for Use of Sonicators
SOP-PPM-244: Standard Operating Procedure for Calibration of HPLC Columns
SOP-PPM-245: Standard Operating Procedure for Use of Gas Analyzers
SOP-PPM-246: Standard Operating Procedure for Temperature Monitoring Systems
SOP-PPM-247: Standard Operating Procedure for Training in Cleanroom Practices
SOP-PPM-248: Standard Operating Procedure for Cleaning and Maintenance of Pipettes
SOP-PPM-249: Standard Operating Procedure for Stability Protocol Preparation
SOP-PPM-250: Standard Operating Procedure for Control of Active Pharmaceutical Ingredients (API)
SOP-PPM-251: Standard Operating Procedure for Preparation of Analytical Test Reports
SOP-PPM-252: Standard Operating Procedure for Preparation of Calibration Certificates
SOP-PPM-253: Standard Operating Procedure for Handling of Glass Breakage in Clean Areas
SOP-PPM-254: Standard Operating Procedure for Control of Temperature and Humidity in Laboratories
SOP-PPM-255: Standard Operating Procedure for Use of Centrifuges
SOP-PPM-256: Standard Operating Procedure for Reagent Shelf-Life Monitoring
SOP-PPM-257: Standard Operating Procedure for Operation of Lyophilizers
SOP-PPM-258: Standard Operating Procedure for Process Water Testing
SOP-PPM-259: Standard Operating Procedure for Control of Packaging Component Quality
SOP-PPM-260: Standard Operating Procedure for Use of Fume Hoods
SOP-PPM-261: Standard Operating Procedure for Storage of Laboratory Samples
SOP-PPM-262: Standard Operating Procedure for Control of Laboratory Glassware
SOP-PPM-263: Standard Operating Procedure for Daily Cleaning of Laboratory Equipment
SOP-PPM-264: Standard Operating Procedure for Disposal of Microbiological Waste
SOP-PPM-265: Standard Operating Procedure for Handling of Biological Samples
SOP-PPM-266: Standard Operating Procedure for Use of Incubators
SOP-PPM-267: Standard Operating Procedure for Calibration of Spectrophotometers
SOP-PPM-268: Standard Operating Procedure for Operation of Laminar Flow Cabinets
SOP-PPM-269: Standard Operating Procedure for Conducting Aseptic Fill-Finish Operations
SOP-PPM-270: Standard Operating Procedure for Cleaning and Sterilization of Tools
SOP-PPM-271: Standard Operating Procedure for Maintenance of Stability Chambers
SOP-PPM-272: Standard Operating Procedure for Verification of Analytical Methods
SOP-PPM-273: Standard Operating Procedure for Trending of Microbial Data
SOP-PPM-274: Standard Operating Procedure for Process Control Sampling
SOP-PPM-275: Standard Operating Procedure for Use of Analytical Standards
SOP-PPM-276: Standard Operating Procedure for Training Documentation
SOP-PPM-277: Standard Operating Procedure for Employee Competency Assessment
SOP-PPM-278: Standard Operating Procedure for Handling of Stability Failures
SOP-PPM-279: Standard Operating Procedure for Training on Safety Procedures
SOP-PPM-280: Standard Operating Procedure for Validation of Packaging Processes
SOP-PPM-281: Standard Operating Procedure for Conducting Root Cause Investigations
SOP-PPM-282: Standard Operating Procedure for Management of Contamination Risks
SOP-PPM-283: Standard Operating Procedure for Microbial Identification Techniques
SOP-PPM-284: Standard Operating Procedure for Calibration of Conductivity Meters
SOP-PPM-285: Standard Operating Procedure for Air Quality Monitoring in Cleanrooms
SOP-PPM-286: Standard Operating Procedure for Preparation of SOPs and Guidelines
SOP-PPM-287: Standard Operating Procedure for Trending and Analysis of Deviation Data
SOP-PPM-288: Standard Operating Procedure for Handling of GMP Documentation
SOP-PPM-289: Standard Operating Procedure for Preparation of Incident Reports
SOP-PPM-290: Standard Operating Procedure for GMP Self-Inspection
SOP-PPM-291: Standard Operating Procedure for Data Integrity Audits
SOP-PPM-292: Standard Operating Procedure for Use of Disinfectants in Cleanrooms
SOP-PPM-293: Standard Operating Procedure for Analytical Data Management
SOP-PPM-294: Standard Operating Procedure for Trending Stability Study Results
SOP-PPM-295: Standard Operating Procedure for Electronic Data Security
SOP-PPM-296: Standard Operating Procedure for Preventive Maintenance of Laboratory Instruments
SOP-PPM-297: Standard Operating Procedure for Quality Control of Aseptic Processes
SOP-PPM-298: Standard Operating Procedure for Use of Sterile Filtration Systems
SOP-PPM-299: Standard Operating Procedure for Line Clearance in Quality Control
SOP-PPM-300: Standard Operating Procedure for Disposal of Chemical Waste
SOP-PPM-301: Standard Operating Procedure for Equipment Labeling and Identification
SOP-PPM-302: Standard Operating Procedure for Handling and Storage of Finished Goods
SOP-PPM-303: Standard Operating Procedure for Validation of Cleaning Processes
SOP-PPM-304: Standard Operating Procedure for HVAC System Maintenance
SOP-PPM-305: Standard Operating Procedure for Training on Good Documentation Practices (GDP)
SOP-PPM-306: Standard Operating Procedure for Validation Master Plan Preparation
SOP-PPM-307: Standard Operating Procedure for Preparation of Annual Product Review
SOP-PPM-308: Standard Operating Procedure for Media Preparation in Microbiology
SOP-PPM-309: Standard Operating Procedure for Control of Non-Conforming Materials
SOP-PPM-310: Standard Operating Procedure for Calibration of UV-Visible Spectrophotometers
SOP-PPM-311: Standard Operating Procedure for Operation of Autoclaves
SOP-PPM-312: Standard Operating Procedure for Conducting Gap Assessments
SOP-PPM-313: Standard Operating Procedure for Microbial Limit Testing
SOP-PPM-314: Standard Operating Procedure for Requalification of Equipment
SOP-PPM-315: Standard Operating Procedure for Handling Returned Goods
SOP-PPM-316: Standard Operating Procedure for Packaging Validation
SOP-PPM-317: Standard Operating Procedure for Disinfection Validation
SOP-PPM-318: Standard Operating Procedure for Operation of Water Purification Systems
SOP-PPM-319: Standard Operating Procedure for Conducting Risk Assessments
SOP-PPM-320: Standard Operating Procedure for Qualification of Compressed Air Systems
SOP-PPM-321: Standard Operating Procedure for Handling and Disposal of Waste Solvents
SOP-PPM-322: Standard Operating Procedure for Environmental Monitoring in Laboratories
SOP-PPM-323: Standard Operating Procedure for Trending of Process Data
SOP-PPM-324: Standard Operating Procedure for Use of Stability Chambers
SOP-PPM-325: Standard Operating Procedure for Operation of HPLC Systems
SOP-PPM-326: Standard Operating Procedure for Operation of Gas Chromatography Systems
SOP-PPM-327: Standard Operating Procedure for Sterility Testing
SOP-PPM-328: Standard Operating Procedure for Use of Analytical Balances
SOP-PPM-329: Standard Operating Procedure for Water Sampling Techniques
SOP-PPM-330: Standard Operating Procedure for Handling of Reference Standards
SOP-PPM-331: Standard Operating Procedure for Cleaning and Maintenance of Laminar Flow Hoods
SOP-PPM-332: Standard Operating Procedure for Temperature-Controlled Storage
SOP-PPM-333: Standard Operating Procedure for Control of Printed Packaging Materials
SOP-PPM-334: Standard Operating Procedure for Labeling Control in Manufacturing
SOP-PPM-335: Standard Operating Procedure for Validation of Analytical Methods
SOP-PPM-336: Standard Operating Procedure for Qualification of Warehouse Facilities
SOP-PPM-337: Standard Operating Procedure for Handling Deviations in Production
SOP-PPM-338: Standard Operating Procedure for Visual Inspection of Filled Units
SOP-PPM-339: Standard Operating Procedure for Aseptic Area Entry and Exit
SOP-PPM-340: Standard Operating Procedure for Water for Injection (WFI) System Monitoring
SOP-PPM-341: Standard Operating Procedure for Management of Analytical Instrumentation
SOP-PPM-342: Standard Operating Procedure for Packaging Material Sampling
SOP-PPM-343: Standard Operating Procedure for Preparation of Calibration Schedules
SOP-PPM-344: Standard Operating Procedure for Filter Integrity Testing
SOP-PPM-345: Standard Operating Procedure for Use of Electronic Document Management Systems
SOP-PPM-346: Standard Operating Procedure for Analytical Method Transfer
SOP-PPM-347: Standard Operating Procedure for Management of Raw Data in Quality Control
SOP-PPM-348: Standard Operating Procedure for Preparation of Cleaning Validation Protocols
SOP-PPM-349: Standard Operating Procedure for Disinfectant Efficacy Testing
SOP-PPM-350: Standard Operating Procedure for Sampling Plan Preparation
SOP-PPM-351: Standard Operating Procedure for Sterilization Process Validation
SOP-PPM-352: Standard Operating Procedure for Filter Qualification
SOP-PPM-353: Standard Operating Procedure for Reprocessing of Non-Conforming Batches
SOP-PPM-354: Standard Operating Procedure for Regulatory Submission Preparation
SOP-PPM-355: Standard Operating Procedure for Cleaning of Cleanroom Garments
SOP-PPM-356: Standard Operating Procedure for Media Fill Trials
SOP-PPM-357: Standard Operating Procedure for Management of Vendor Qualification
SOP-PPM-358: Standard Operating Procedure for Aseptic Process Simulation
SOP-PPM-359: Standard Operating Procedure for Handling Out-of-Specification Results
SOP-PPM-360: Standard Operating Procedure for Equipment Decommissioning
SOP-PPM-361: Standard Operating Procedure for Quality Risk Management
SOP-PPM-362: Standard Operating Procedure for Monitoring of Compressed Gases
SOP-PPM-363: Standard Operating Procedure for Operation of Freeze Dryers
SOP-PPM-364: Standard Operating Procedure for Use of Conductivity Meters
SOP-PPM-365: Standard Operating Procedure for Reagent Inventory Management
SOP-PPM-366: Standard Operating Procedure for Process Validation Protocol Preparation
SOP-PPM-367: Standard Operating Procedure for Laboratory Incident Management
SOP-PPM-368: Standard Operating Procedure for Identification of Microbial Contaminants
SOP-PPM-369: Standard Operating Procedure for pH Measurement and Calibration
SOP-PPM-370: Standard Operating Procedure for Electronic Record Keeping
SOP-PPM-371: Standard Operating Procedure for Analytical Method Development
SOP-PPM-372: Standard Operating Procedure for Microbial Sampling Techniques
SOP-PPM-373: Standard Operating Procedure for Stability Testing of Finished Products
SOP-PPM-374: Standard Operating Procedure for Management of Change Control Requests
SOP-PPM-375: Standard Operating Procedure for Documentation Control
SOP-PPM-376: Standard Operating Procedure for Training on GMP Regulations
SOP-PPM-377: Standard Operating Procedure for Batch Record Review
SOP-PPM-378: Standard Operating Procedure for Use of High-Purity Water Systems
SOP-PPM-379: Standard Operating Procedure for Preparation of Master Batch Records
SOP-PPM-380: Standard Operating Procedure for Warehouse Management
SOP-PPM-381: Standard Operating Procedure for Handling and Storage of APIs
SOP-PPM-382: Standard Operating Procedure for Qualification of Cold Storage Units
SOP-PPM-383: Standard Operating Procedure for Calibration of Analytical Instruments
SOP-PPM-384: Standard Operating Procedure for Validation of Mixing Processes
SOP-PPM-385: Standard Operating Procedure for Conducting Internal Audits
SOP-PPM-386: Standard Operating Procedure for Management of Product Complaints
SOP-PPM-387: Standard Operating Procedure for Quality Metrics Reporting
SOP-PPM-388: Standard Operating Procedure for Handling Product Recalls
SOP-PPM-389: Standard Operating Procedure for GMP Training Program
SOP-PPM-390: Standard Operating Procedure for Visual Inspection of Components
SOP-PPM-391: Standard Operating Procedure for Use of Dissolution Testers
SOP-PPM-392: Standard Operating Procedure for Management of Environmental Monitoring Data
SOP-PPM-393: Standard Operating Procedure for Investigation of Atypical Results
SOP-PPM-394: Standard Operating Procedure for Endotoxin Testing
SOP-PPM-395: Standard Operating Procedure for Media Growth Promotion Testing
SOP-PPM-396: Standard Operating Procedure for Calibration of Laboratory Equipment
SOP-PPM-397: Standard Operating Procedure for Data Integrity Monitoring
SOP-PPM-398: Standard Operating Procedure for Qualification of Manufacturing Equipment
SOP-PPM-399: Standard Operating Procedure for Sampling of Bulk Materials
SOP-PPM-400: Standard Operating Procedure for Management of GMP Audits
SOP-PPM-401: Standard Operating Procedure for Investigation of Non-Conformances
SOP-PPM-402: Standard Operating Procedure for Maintenance of Stability Chambers
SOP-PPM-403: Standard Operating Procedure for Cleaning Validation in Aseptic Processing
SOP-PPM-404: Standard Operating Procedure for Sampling and Testing of Packaging Materials
SOP-PPM-405: Standard Operating Procedure for Handling and Disposal of Biohazard Waste
SOP-PPM-406: Standard Operating Procedure for Line Clearance in Manufacturing Areas
SOP-PPM-407: Standard Operating Procedure for Cleaning and Maintenance of Production Areas
SOP-PPM-408: Standard Operating Procedure for Calibration of Digital Thermometers
SOP-PPM-409: Standard Operating Procedure for Operation of Centrifuges
SOP-PPM-410: Standard Operating Procedure for Pest Control in Production Facilities
SOP-PPM-411: Standard Operating Procedure for Handling of Highly Potent Active Pharmaceutical Ingredients (HPAPIs)
SOP-PPM-412: Standard Operating Procedure for Process Change Control
SOP-PPM-413: Standard Operating Procedure for Validation of Sterile Filtration
SOP-PPM-414: Standard Operating Procedure for Qualification of Steam Sterilizers
SOP-PPM-415: Standard Operating Procedure for Sampling of Water for Injection (WFI)
SOP-PPM-416: Standard Operating Procedure for Process Robustness Studies
SOP-PPM-417: Standard Operating Procedure for Data Backup and Recovery in Quality Control
SOP-PPM-418: Standard Operating Procedure for Deviation Reporting and Investigation
SOP-PPM-419: Standard Operating Procedure for Periodic Product Review
SOP-PPM-420: Standard Operating Procedure for Packaging Line Reconciliation
SOP-PPM-421: Standard Operating Procedure for Reworking of Non-Compliant Products
SOP-PPM-422: Standard Operating Procedure for Cleaning and Disinfection of Controlled Areas
SOP-PPM-423: Standard Operating Procedure for Operation of Lyophilizers
SOP-PPM-424: Standard Operating Procedure for Microbial Identification
SOP-PPM-425: Standard Operating Procedure for Use of Differential Scanning Calorimeters (DSC)
SOP-PPM-426: Standard Operating Procedure for Conducting Pre-Approval Inspections (PAI)
SOP-PPM-427: Standard Operating Procedure for Storage of Controlled Substances
SOP-PPM-428: Standard Operating Procedure for Analytical Instrument Qualification (AIQ)
SOP-PPM-429: Standard Operating Procedure for Aseptic Sampling Techniques
SOP-PPM-430: Standard Operating Procedure for Corrective and Preventive Actions (CAPA)
SOP-PPM-431: Standard Operating Procedure for Label Reconciliation in Packaging
SOP-PPM-432: Standard Operating Procedure for Stability Study Management
SOP-PPM-433: Standard Operating Procedure for Handling and Storage of Cold Chain Products
SOP-PPM-434: Standard Operating Procedure for Validation of Blending Processes
SOP-PPM-435: Standard Operating Procedure for Process Simulation Studies
SOP-PPM-436: Standard Operating Procedure for Water System Sanitization
SOP-PPM-437: Standard Operating Procedure for Visual Inspection of Sterile Products
SOP-PPM-438: Standard Operating Procedure for Analytical Method Verification
SOP-PPM-439: Standard Operating Procedure for Management of Product Hold and Release
SOP-PPM-440: Standard Operating Procedure for Cleaning and Maintenance of Pass Boxes
SOP-PPM-441: Standard Operating Procedure for Handling of Cytotoxic Compounds
SOP-PPM-442: Standard Operating Procedure for Continuous Process Verification
SOP-PPM-443: Standard Operating Procedure for Validation of Weighing Balances
SOP-PPM-444: Standard Operating Procedure for Cleaning Validation in Non-Sterile Areas
SOP-PPM-445: Standard Operating Procedure for Control of Packaging Line Operations
SOP-PPM-446: Standard Operating Procedure for Use of Fourier Transform Infrared Spectroscopy (FTIR)
SOP-PPM-447: Standard Operating Procedure for Gowning Procedures in Cleanrooms
SOP-PPM-448: Standard Operating Procedure for Operation of Tablet Compression Machines
SOP-PPM-449: Standard Operating Procedure for Management of Product Complaints and Investigations
SOP-PPM-450: Standard Operating Procedure for Operation of Capsule Filling Machines
SOP-PPM-451: Standard Operating Procedure for Validation of Lyophilization Cycles
SOP-PPM-452: Standard Operating Procedure for Operation of Blister Packaging Machines
SOP-PPM-453: Standard Operating Procedure for Particulate Matter Testing
SOP-PPM-454: Standard Operating Procedure for Stability Testing of APIs
SOP-PPM-455: Standard Operating Procedure for Use of Atomic Absorption Spectrophotometers (AAS)
SOP-PPM-456: Standard Operating Procedure for Out-of-Trend (OOT) Investigations
SOP-PPM-457: Standard Operating Procedure for Bioburden Testing
SOP-PPM-458: Standard Operating Procedure for Handling of Controlled Drug Substances
SOP-PPM-459: Standard Operating Procedure for Operation of Fluid Bed Dryers
SOP-PPM-460: Standard Operating Procedure for Preventive Maintenance Scheduling
SOP-PPM-461: Standard Operating Procedure for Raw Material Retesting
SOP-PPM-462: Standard Operating Procedure for Operation of Granulation Equipment
SOP-PPM-463: Standard Operating Procedure for Investigation of Cross-Contamination Incidents
SOP-PPM-464: Standard Operating Procedure for Operation of Coating Pans
SOP-PPM-465: Standard Operating Procedure for Management of Quality Control Reference Materials
SOP-PPM-466: Standard Operating Procedure for Process Capability Analysis
SOP-PPM-467: Standard Operating Procedure for Conducting Media Fill Simulations
SOP-PPM-468: Standard Operating Procedure for Cleanroom Monitoring
SOP-PPM-469: Standard Operating Procedure for Operation of High-Shear Mixers
SOP-PPM-470: Standard Operating Procedure for Batch Numbering System
SOP-PPM-471: Standard Operating Procedure for Operation of Rotary Tablet Presses
SOP-PPM-472: Standard Operating Procedure for Use of Karl Fischer Titration
SOP-PPM-473: Standard Operating Procedure for Qualification of Refrigerators and Freezers
SOP-PPM-474: Standard Operating Procedure for Cleaning and Maintenance of HVAC Filters
SOP-PPM-475: Standard Operating Procedure for Handling Temperature Excursions
SOP-PPM-476: Standard Operating Procedure for Filter Validation Studies
SOP-PPM-477: Standard Operating Procedure for Documentation of Corrective Actions
SOP-PPM-478: Standard Operating Procedure for Operation of Packaging Inspection Systems
SOP-PPM-479: Standard Operating Procedure for Qualification of Warehouse Temperature Mapping
SOP-PPM-480: Standard Operating Procedure for Monitoring of Relative Humidity
SOP-PPM-481: Standard Operating Procedure for Conducting Product Stability Trending
SOP-PPM-482: Standard Operating Procedure for Use of Microbial Air Samplers
SOP-PPM-483: Standard Operating Procedure for Management of Raw Material Expiry Dates
SOP-PPM-484: Standard Operating Procedure for Management of GMP Audit Observations
SOP-PPM-485: Standard Operating Procedure for Operation of Induction Sealers
SOP-PPM-486: Standard Operating Procedure for Use of Polarimeters
SOP-PPM-487: Standard Operating Procedure for Identification and Handling of Counterfeit Products
SOP-PPM-488: Standard Operating Procedure for Container Closure Integrity Testing
SOP-PPM-489: Standard Operating Procedure for Use of Turbidimeters
SOP-PPM-490: Standard Operating Procedure for Conducting Moisture Content Analysis
SOP-PPM-491: Standard Operating Procedure for Validation of Blister Packaging Processes
SOP-PPM-492: Standard Operating Procedure for Wastewater Treatment System Monitoring
SOP-PPM-493: Standard Operating Procedure for Trending of Environmental Monitoring Data
SOP-PPM-494: Standard Operating Procedure for Validation of Clean-in-Place (CIP) Systems
SOP-PPM-495: Standard Operating Procedure for Cold Chain Distribution Management
SOP-PPM-496: Standard Operating Procedure for Sampling of Liquid Products
SOP-PPM-497: Standard Operating Procedure for Stability Testing of Biological Products
SOP-PPM-498: Standard Operating Procedure for Reconciliation of Bulk Products
SOP-PPM-499: Standard Operating Procedure for Operation of Visual Inspection Machines
SOP-PPM-500: Standard Operating Procedure for Process Validation Report Preparation

About Fhyzics

Fhyzics Business Consultants Private Limited, specializes in Consulting, Certifications and Executive Development Program (EDP) in the domains of business analysis, new product development and supply chain management. Fhyzics is a global leader in the design, development, implementation and auditing of Standard Operating Procedures and serves companies across the globe in over 50 verticals. Fhyzics offers the certification programs of APICS/ASCM, USA; CIPS, UK; IREB, Germany; IIBA, Canada; PDMA, USA and BCS, UK.

Please write to us at Consulting@Fhyzics.net or speak to us at +91-900-304-9000

Terms and Conditions of SOP ToolBox & SOP Template

As part of the SOP ToolBox, you will receive SOP Templates as listed in this page.
Fhyzics’ SOP Team works Monday through Friday from 9:00 AM to 5:00 PM (Indian Local Time). A response will be provided within 4 hours for purchases made during this window. Purchases made outside of this window will take up to 1 business day.
Refund is NOT admissible after the commencement of delivery of our service either in part or full. Hence, we request potential clients evaluate the suitability of SOP ToolBox / SOP Templates before purchase by asking for samples from our team. You can reach out to the SOP Team at +91-900-304-9000 (WhatsApp) or email at Consulting@Fhyzics.net.
We take necessary care to recommend an exhaustive list of SOP Templates for you to choose from based on your industry or function or a combination of industry-function. Some degree of customization would still be required at your end on the SOP Templates.
We would request you to provide your organization name, address, and logo to customise the SOP Documents.
SOP ToolBox is not a ready-to-download document or software. Rather, it is specifically customised for your needs from our base SOP Document Repository.
SOP Templates may have references to software, applications, checklists, forms, agreements, process maps and other resources/documents. The deliverable for an SOP Template / ToolBox is only the SOP Template and it doesn’t include the above items referenced within the SOP Template.
Disclaimer Statement: The Standard Operating Procedures (SOPs) Templates provided by the Fhyzics team are developed with due diligence, taking into account industry norms, geographical factors, regulatory requirements, and specific contexts to the best of our ability. Despite our commitment to quality and relevance, these documents are crafted remotely at a significantly reduced cost, without the benefit of on-site visits or direct, elaborate interactions with key stakeholders of the client's business. It is important to acknowledge that while we strive for excellence, our remote development process may not capture all nuances of a business's unique operational environment. Therefore, the documents delivered by Fhyzics should be regarded as a preliminary resource or starting point (hence named SOP Template). We strongly recommend that you thoroughly review these documents with qualified experts familiar with your specific operational context before proceeding with implementation. This review is crucial to ensure that the documents align with your business's processes and comply with all relevant regulations and best practices.

Please write to us at Consulting@Fhyzics.net or speak to us at +91-900-304-9000

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SOP ToolBox - Pharmaceutical Preparation Manufacturing

SOP Templates for Pharmaceutical Preparation Manufacturing

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