What can we expect during the VPP uniform inspection?
After you have submitted your application and payment, your pharmacy may be inspected at any time. You are expected to be familiar with, and be operating under, all applicable regulations. The inspection is a snapshot in time.
As this is a general inspection, some items may not be required by the state of residence. The VPP inspection observes alignment with USP Nonsterile <795>, Sterile <797>, Hazardous Drug Compounding <800>, and Nuclear/Radiopharmaceutical <825>, as applicable. NABP does not make a determination of “passed” with regard to any specific state regulations.
- General Pharmacy Inspection
- Nonsterile Compounding Inspection
- Sterile Compounding Inspection
- Hazardous Drug Compounding
- Nuclear/ Radiopharmaceutical
The General Pharmacy Inspection covers questions in the following areas:
- General Operations and Licensure
- Personnel
- Facility and Security
- Product Receipt and Inventory
- Prescription Processing
- Patient Counseling and Communication
- Quality Assurance/Quality Improvement Program
The information and comments obtained in the nonsterile compounding and sterile compounding supplement inspections are based on USP Chapters <795> and <797>, respectively. An inspection against current Good Manufacturing Practices (cGMPs) is not conducted.
The Nonsterile Compounding Inspection covers questions in the following areas:
- Standard Operating Procedures (SOPs) for Compounded Nonsterile Preparations (CNSPs)
- Designated Person(s) and Personnel Training Program
- Compounding Personal Hygiene and Garbing
- Buildings and Facilities
- Cleaning and Sanitizing
- Equipment and Components
- Master Formulation Records (MFR) and Compounding Records (CR)
- Labeling
- Establishing Beyond Use Dating (BUDs)
- Quality Assurance (QA), Quality Control (QC), and Quality Management (QM)
- CNSP Packaging
- Compounding Personnel Observations
- Records Review
The Sterile Compounding Inspection covers questions in the following areas:
- Standard Operating Procedures (SOPs) for Compounded Sterile Preparations (CSPs)
- CSPs – Immediate Use, Proprietary Vial/Bag Systems, and Blood-Derived
- Facility Design and Engineering Controls
- Certification and Environmental Monitoring
- Compounding Personal Hygiene and Garbing
- Media-Fill
- Cleaning and Disinfection
- Components
- Equipment and Supplies
- Compounding Personnel Observations
- Sterilization and Depyrogenation
- Master Formulation and Compounding Records (CR)
- Establishing Beyond Use Dating (BUDs)
- Finished Preparation Release Checks and Tests
- CSP Packaging, Shipping and Transport
- Quality Assurance (QA) and Quality Control (QC)
- Personnel Training and Evaluation
- Records Review
The Hazardous Drug Compounding Inspection covers questions in the following areas:
- General Information and Scope
- List of Hazardous Drugs
- Personnel Responsibilities
- Documentation and Standard Operating Procedures (SOPs)
- Personnel Training
- Personal Protective Equipment
- Facilities and Engineering Controls
- Environmental Quality and Control – Surface wipe sampling
- Receiving
- Labeling, Packaging, Transport, and Disposal
- Dispensing, Packaging, and Compounding Processes
- Deactivating and Decontaminating (Cleaning and Disinfecting are performed in accordance with Chapters <795> and <797>)
- Spill Control
The Nuclear/Radiopharmaceutical Inspection covers questions in the following areas:
- Immediate Use of Sterile Radiopharmaceuticals
- Personnel Qualifications, Training, and Hygiene
- Aseptic Qualifications
- Gloved Fingertip and Thumb Sampling
- Media-Fill Testing
- Reevaluation, Retraining, and Requalification
- Timing of Reevaluation and Requalification
- Ancillary Personnel
- Hand Hygiene and Garbing for Immediate Use Preparations
- Hand Hygiene and Garbing for Buffer Areas and Segregated Radiopharmaceutical Processing Area
- Facilities and Engineering Controls
- Facility and Security
- Facility Design and Environmental Controls
- Types of Secondary Engineering Controls and Design
- The Radiopharmaceutical Processing Environment
- Types of Primary Engineering Controls (PECs) and Placement
- Air-Exchange Requirements
- Creating Areas to Achieve Easily Cleanable Conditions
- Classified Areas
- Segregated Radiopharmaceutical Processing Area (SRPA)
- Water Sources
- Placement and Movement of Materials
- Classified Areas
- Remote Aseptic Processing Involving a Hot-Cell
- Environmental Controls
- Establishing and Maintaining Pressure Differentials
- Ambient Atmosphere for Immediate Use Preparations
- SRPA with Vertical Flow ISO Class 5 PEC(s) for Radiopharmaceutical Preparations
- An ISO Class 8 Buffer Area with Vertical Flow ISO Class 5 PEC(s) with an Adjacent ISO Class 8 Ante-Room
- An ISO Class 7 Buffer Area with Vertical Flow ISO Class 5 PEC(s) with an Adjacent ISO Class 8 Ante-Room
- Hot-Cell
- Certification of PEC and Environment in which the PEC is located
- Daily Monitoring of Environment
- Microbial Air and Surface Monitoring
- General Monitoring Requirements
- Monitoring Air Quality for Viable Airborne Particles
- Viable Air Sampling: Timing and Locations
- Data Evaluation and Action Levels
- Monitoring Surfaces for Viable Particles
- Surface Sampling: Timing and Locations
- Sampling Procedures
- Data Evaluation and Action Levels
- Cleaning and Disinfecting
- Minimum Frequency for Cleaning and Disinfecting Surfaces in Classified Areas and within the perimeter of the SRPA
- Cleaning, Disinfecting, and Sporicidal Agents
- Cleaning Supplies
- Cleaning and Disinfecting the PEC
- Disinfecting Supplies for Classified Areas and SRPAs
- Disinfecting Critical Sites
- Cleaning and Disinfecting Items from Patient Care Area
- Assigning Beyond Use Dating (BUDs)
- Documentation
- Master Formulation Record (MFR)
- Records for Preparation with Minor Deviations/Compounding
- Preparation
- Preparation Following Manufacturer Instructions
- Nonsterile Preparations
- Sterile Preparations
- Preparation with Minor Deviations
- Preparation of Radiolabeled Blood Components
- Preparation of Radiolabeled Red Blood Cells for Immediate Use
- Preparation Following Manufacturer Instructions
- Compounding
- Compounding Nonsterile Radiopharmaceuticals
- Sterile Compounding
- Sterile Compounding Using Nonsterile Drug Substance or Components
- Dispensing and Radioassay
- Labeling
- Direct Infusion Systems
- Transporting Generators Between Facilities
- Repackaging
- Quality Assurance (QA) and Quality Control (QC)
- Notification About and Recall of Out-of-Specification Dispensed Radiopharmaceuticals
- Complaint Handling
- Adverse Event Reporting