Quality Assurance SOPs

SOP's listed as links are currently available. Others will be coming soon.
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Number Title
9.001 Quality Assurance Officer
9.002 Quality Assurance for Nonsterile Preparations
9.003 Quality Assurance for Sterile Preparations
9.005 Evaluating and Selecting an Analytical Testing Laboratory
9.005.1 External Laboratory Testing
9.005.2 Responding to Out-of-Specifications Testing Results
9.005.3 Failure Investigation
9.006 Lab Proficiency Testing
9.008 Complaint and Mishap Rectification
9.01 Certificates of Analysis of Materials Used for Pharmaceutical Compounding
9.012 Infection Control
9.013 Testing of Water Supply: Barnstead D4751 High Purity Water System
9.014 Procedures in the Event of Nonconformance of Preparations or Chemicals
9.015 Syringe - Determining the Volume Within
9.016 Product Quarantine, Storage & Release
9.018 Sample Testing Frequency
9.02 Product Quality Defect Reporting
9.021 Sterility and Endotoxin Testing
9.021.01 Pyrogen Testing
9.022 Sterility Testing
9.022.01 Soy Testing - Millipore Addi-Chek
9.022.02 Sterility Test for Ophthalmic Solutions
9.023 Quality Assessment for Injectable Solutions
9.024 Quality Assessment of Oral and Topical Liquids
9.025 Quality Assessment of Compounded Parentral Nutrition Preparations
9.026 Quality Assessment of Powder-Filled, Hard-Gelatin Capsules
9.027 Quality Assessment of Special Hard-Gelatin Capsules
9.028 Quality Assessment of Nasal Solutions
9.029 Physical Quality Assessment of Ointments / Creams / Gels
9.03 Particulate Testing for Sterile Preparations
9.031 Performing Physical Quality Assessment of Suppositories, Troches, Lollipops, and Sticks
9.035 Visual Inspection of a Finished Product
9.036 Checking a Compounded Prescription
9.037 Drug Quality Defect Reporting
9.038 Surface Sampling Plan
9.039 Visual Inspection of a Finished Preparation
9.040 Sterility Testing of a Finished Preparation
9.040.1 Method Suitability Testing For Sterility Testing of Compounded Preparations
9.040.2 Investigation of Sterility Test Failure
9.041 Performing a Sterilty Assay on Ophthalmic Solutions Using a TSB Medium Bottle
9.042 Endotoxin Testing of a Finished Preparation (Outsourced)
9.043 Measuring Particulate Matter Levels within the Compounding Hoods
9.044 Measuring Particulate Matter Levels within the Cleanroom-Clean Area
9.045 Cleanroom-Clean Area Certification Schedule
9.046 Verification of Order-Prescription to Finished Product
9.047 Microbiologist-Quality Control
9.048 Medication Error Reporting
9.049 Filing Quality Assurance Documents
9.050 Monitoring Sterile Area Using the Swab Test
9.051 Microbial Testing of Purified Water
9.052 Microbial Limit Tests
9.054 Nitrogen Vent Filter Integrity Testing
9.056 Tablet Hardness Tester
9.057 Tablet Friability Test Apparatus
9.058 Disintegration Test Apparatus
9.059 Visual Inspection
9.06 Quality Standards Continuous Improvement