Bot Detector

Quality Assurance SOPs

SOP's listed as links are currently available. Others will be coming soon.
If SOP document does NOT open in new window properly, try RIGHT-CLICKING the link and select Save Target As... to save the file to your computer. Then open it from within your word processor.
Number Updated Reviewed  Title
9.001 4/7/05 10/18/23 Quality Assurance Officer
9.002 9/24/09 10/18/23 Quality Assurance for Nonsterile Preparations
9.002 u 8/21/19 10/18/23 Quality Assurance for Nonsterile Preparations (USP 2019)
9.003 9/24/09 10/18/23 Quality Assurance for Sterile Preparations
9.003 u 8/21/19 10/18/23 Quality Assurance for Sterile Preparations (USP 2019)
9.005 4/7/05 10/18/23 Evaluating and Selecting an Analytical Testing Laboratory
9.005.1 8/11/08 10/18/23 External Laboratory Testing
9.005.2 1/8/15 10/18/23 Responding to Out-of-Specifications Testing Results
9.005.2 u 8/21/19 10/18/23 Responding to Out-of-Specifications Testing Results (USP 2019)
9.005.3 10/26/18 10/18/23 Failure Investigation
9.006 4/7/05 10/18/23 Lab Proficiency Testing
9.008 4/7/05 10/18/23 Complaint and Mishap Rectification
9.008 u 8/21/19 10/18/23 Complaint and Mishap Rectification (USP 2019)
9.01 4/7/05 10/18/23 Certificates of Analysis of Materials Used for Pharmaceutical Compounding
9.012 3/30/15 10/18/23 Infection Control
9.013 4/7/05 10/18/23 Testing of Water Supply: Barnstead D4751 High Purity Water System
9.014 4/7/05 10/18/23 Procedures in the Event of Nonconformance of Preparations or Chemicals
9.015 4/7/05 10/18/23 Syringe - Determining the Volume Within
9.016 4/7/05 10/18/23 Product Quarantine, Storage & Release
9.016 u 8/21/19 10/18/23 Product Quarantine, Storage & Release (USP 2019)
9.018 4/7/05 10/18/23 Sample Testing Frequency
9.02 8/11/08 10/18/23 Product Quality Defect Reporting
9.021 4/7/05 10/18/23 Sterility and Endotoxin Testing
9.021.01 8/11/08 10/18/23 Pyrogen Testing
9.022 8/11/08 10/18/23 Sterility Testing
9.022.01 4/14/05 10/18/23 Soy Testing - Millipore Addi-Chek
9.022.02 4/14/05 10/18/23 Sterility Test for Ophthalmic Solutions
9.023 4/14/05 10/18/23 Quality Assessment for Injectable Solutions
9.024 4/14/05 10/18/23 Quality Assessment of Oral and Topical Liquids
9.025 4/14/05 10/18/23 Quality Assessment of Compounded Parentral Nutrition Preparations
9.026 4/14/05 10/18/23 Quality Assessment of Powder-Filled, Hard-Gelatin Capsules
9.026a 7/9/21 10/18/23 Quality Assessment of Powder-Filled, Hard-Gelatin T3 and T4 Capsules
9.027 4/14/05 10/18/23 Quality Assessment of Special Hard-Gelatin Capsules
9.028 4/14/05 10/18/23 Quality Assessment of Nasal Solutions
9.029 4/14/05 10/18/23 Physical Quality Assessment of Ointments / Creams / Gels
9.03 4/14/05 10/18/23 Particulate Testing for Sterile Preparations
9.031 4/14/05 10/18/23 Performing Physical Quality Assessment of Suppositories, Troches, Lollipops, and Sticks
9.035 7/21/08 10/18/23 Visual Inspection of a Finished Product
9.036 7/21/08 10/18/23 Checking a Compounded Prescription
9.037 7/21/08 10/18/23 Drug Quality Defect Reporting
9.038 8/11/08 10/18/23 Surface Sampling Plan
9.039 8/22/08 10/18/23 Visual Inspection of a Finished Preparation
9.040 8/22/08 10/18/23 Sterility Testing of a Finished Preparation
9.040 u 8/21/19 10/18/23 Sterility Testing of a Finished Preparation (USP 2019)
9.040.1 2/7/17 10/18/23 Method Suitability Testing For Sterility Testing of Compounded Preparations
9.040.2 10/26/18 10/18/23 Investigation of Sterility Test Failure
9.041 8/22/08 10/18/23 Performing a Sterilty Assay on Ophthalmic Solutions Using a TSB Medium Bottle
9.042 8/22/08 10/18/23 Endotoxin Testing of a Finished Preparation (Outsourced)
9.043 8/27/08 10/18/23 Measuring Particulate Matter Levels within the Compounding Hoods
9.044 8/27/08 10/18/23 Measuring Particulate Matter Levels within the Cleanroom-Clean Area
9.045 8/27/08 10/18/23 Cleanroom-Clean Area Certification Schedule
9.046 9/5/08 10/18/23 Verification of Order-Prescription to Finished Product
9.047 9/16/08 10/18/23 Microbiologist-Quality Control
9.048 8/5/10 10/18/23 Medication Error Reporting
9.049 5/14/12 10/18/23 Filing Quality Assurance Documents
9.050 5/30/12 10/18/23 Monitoring Sterile Area Using the Swab Test
9.051 5/30/12 10/18/23 Microbial Testing of Purified Water
9.052 5/30/12 10/18/23 Microbial Limit Tests
9.054 5/30/12 10/18/23 Nitrogen Vent Filter Integrity Testing
9.056 5/30/12 10/18/23 Tablet Hardness Tester
9.057 5/30/12 10/18/23 Tablet Friability Test Apparatus
9.058 5/30/12 10/18/23 Disintegration Test Apparatus
9.059 5/30/12 10/18/23 Visual Inspection
9.06 7/17/14 10/18/23 Quality Standards Continuous Improvement