Audit Checklist for Product Development Department

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This document presents a comprehensive audit checklist for the Product Development Department, highlighting the key and most effective checkpoints applicable to a pharmaceutical company.   A. DOCUMENTATION AND RECORD MANAGEMENT Availability of approved Standard Operating Procedures (SOPs) for all activities SOP review and revision frequency compliance Document numbering and version control system Master document control […]

This document presents a comprehensive audit checklist for the Product Development Department, highlighting the key and most effective checkpoints applicable to a pharmaceutical company.

 

A. DOCUMENTATION AND RECORD MANAGEMENT

  1. Availability of approved Standard Operating Procedures (SOPs) for all activities
  2. SOP review and revision frequency compliance
  3. Document numbering and version control system
  4. Master document control procedures
  5. Authorization signatures on all documents
  6. Document distribution and retrieval records
  7. Obsolete document handling procedures
  8. Electronic document management system validation
  9. Laboratory notebook maintenance and review
  10. Raw data recording practices
  11. Error correction procedures (single line, initials, date)
  12. Use of permanent ink for documentation
  13. Blank space handling in records
  14. Attachment and labeling of supplementary data
  15. Document archival and retention policies
  16. Retrieval system for archived documents
  17. Batch record template approval process
  18. Protocol and report approval workflows
  19. Cross-referencing between related documents
  20. Legibility and completeness of handwritten entries

B. QUALITY MANAGEMENT SYSTEM

  1. Quality policy documentation and communication
  2. Quality objectives and KPIs for development
  3. Management review meeting records
  4. Internal audit schedule and execution
  5. CAPA system effectiveness
  6. Quality risk management procedures
  7. Supplier qualification program
  8. Contract laboratory qualification
  9. Out-of-specification (OOS) investigation procedures
  10. Out-of-trend (OOT) investigation procedures
  11. Complaint handling related to development batches
  12. Annual product quality review for development
  13. Quality agreements with external partners
  14. Deviation management system
  15. Change control procedures
  16. Product quality review meetings
  17. Quality metrics trending and analysis
  18. Continuous improvement initiatives
  19. Quality culture and awareness programs
  20. Customer feedback integration into development

C. PERSONNEL AND TRAINING

  1. Organizational chart with clear reporting lines
  2. Job descriptions for all positions
  3. Qualification requirements for each role
  4. Training matrix and curriculum
  5. Initial training records for new employees
  6. Ongoing/refresher training compliance
  7. GMP training documentation
  8. Safety training records
  9. Competency assessment procedures
  10. Training effectiveness evaluation
  11. External training and conference attendance
  12. Cross-training programs
  13. Trainer qualification records
  14. Training on new SOPs before implementation
  15. Role-specific technical training
  16. Documentation practices training
  17. Data integrity training
  18. Equipment operation training
  19. Training records accessibility and completeness
  20. Succession planning and knowledge transfer

D. FACILITIES AND ENVIRONMENT 

  1. Facility layout and material flow diagrams
  2. Personnel flow patterns
  3. Cleanroom classification and certification
  4. Environmental monitoring program
  5. Temperature and humidity monitoring
  6. Pressure differential monitoring and records
  7. HVAC system qualification
  8. Air handling unit maintenance
  9. HEPA filter integrity testing
  10. Lighting adequacy in work areas
  11. Pest control program
  12. Cleaning and sanitation procedures
  13. Cleaning validation for development areas
  14. Segregation of different product types
  15. Containment facilities for potent compounds
  16. Waste disposal procedures
  17. Utilities qualification (water, gases, compressed air)
  18. Emergency systems (power backup, safety showers)
  19. Access control to development areas
  20. Facility maintenance and repair records

E. EQUIPMENT MANAGEMENT 

  1. Equipment inventory and identification
  2. Equipment qualification protocols (IQ/OQ/PQ)
  3. Qualification status documentation
  4. Preventive maintenance schedules
  5. Maintenance records and logs
  6. Calibration program and schedules
  7. Calibration certificates and traceability
  8. Out-of-calibration investigation
  9. Equipment cleaning procedures
  10. Equipment use logs
  11. Equipment status labeling
  12. Critical instrument identification
  13. Spare parts inventory management
  14. Equipment change control
  15. User access controls for equipment
  16. Equipment validation for intended use
  17. Breakdown/repair documentation
  18. Equipment performance trending
  19. Retired equipment handling
  20. Shared equipment management protocols

F. RAW MATERIALS AND EXCIPIENTS 

  1. Vendor qualification and approval
  2. Material specifications and COAs
  3. Incoming material inspection procedures
  4. Sampling procedures for raw materials
  5. Material identity testing
  6. Storage conditions compliance
  7. Material status labeling (quarantine/approved/rejected)
  8. Expiry/retest date management
  9. FIFO/FEFO inventory management
  10. Reference standard management
  11. Excipient compatibility studies
  12. Material safety data sheets availability
  13. Controlled substance handling procedures
  14. Material reconciliation procedures
  15. Rejection and return procedures

G. FORMULATION DEVELOPMENT 

  1. Pre-formulation study documentation
  2. Drug-excipient compatibility studies
  3. Formulation development protocols
  4. Design of Experiments (DoE) application
  5. Critical Quality Attributes (CQA) identification
  6. Critical Process Parameters (CPP) identification
  7. Prototype formulation records
  8. Scale-up considerations in development
  9. Formulation optimization studies
  10. Placebo formulation development
  11. Comparative dissolution studies
  12. Bioavailability enhancement strategies
  13. Modified release formulation development
  14. Formulation stability indicating methods
  15. Packaging compatibility studies
  16. Photostability studies
  17. Container closure system selection
  18. Preservative efficacy testing
  19. Formulation robustness studies
  20. Technology platform documentation

H. ANALYTICAL METHOD DEVELOPMENT 

  1. Method development protocols
  2. Method suitability studies
  3. Method validation master plan
  4. Specificity/selectivity validation
  5. Linearity and range validation
  6. Accuracy validation
  7. Precision (repeatability, intermediate, reproducibility)
  8. Detection limit determination
  9. Quantitation limit determination
  10. Robustness studies
  11. System suitability parameters
  12. Reference standard characterization
  13. Impurity identification and qualification
  14. Forced degradation studies
  15. Method transfer protocols
  16. Method transfer acceptance criteria
  17. Analytical method lifecycle management
  18. Method verification procedures
  19. Compendial method verification
  20. Analytical target profile documentation

I. STABILITY STUDIES 

  1. Stability study design and protocols
  2. ICH guidelines compliance
  3. Stability chamber qualification
  4. Stability chamber monitoring and alarms
  5. Stability sample management
  6. Stability testing schedule adherence
  7. Stability indicating method validation
  8. Stability data trending and analysis
  9. Out-of-specification stability results handling
  10. Photostability study design
  11. Stress testing conditions
  12. Container closure integrity during stability
  13. Stability commitments to regulatory agencies
  14. Annual stability program
  15. Stability data reporting and archival

J. PROCESS DEVELOPMENT AND SCALE-UP 

  1. Process development documentation
  2. Process flow diagrams
  3. Critical process parameters identification
  4. Process design space definition
  5. Quality by Design (QbD) implementation
  6. Scale-up protocols and reports
  7. Process validation strategy
  8. Technology transfer protocols
  9. Manufacturing site qualification
  10. Process capability studies
  11. In-process controls development
  12. Process analytical technology (PAT) application
  13. Batch size justification
  14. Equipment train qualification
  15. Process risk assessment (FMEA)

K. LABORATORY CONTROLS 

  1. Laboratory SOPs availability and currency
  2. Reagent and solution preparation records
  3. Reagent labeling (name, concentration, date, expiry)
  4. Volumetric solution standardization
  5. Reference standard storage and handling
  6. Working standard preparation
  7. Laboratory sample management
  8. Sample retention policies
  9. Laboratory waste management
  10. Safety equipment availability and inspection
  11. Laboratory housekeeping standards
  12. Instrument logbooks maintenance
  13. Out-of-specification investigation records
  14. Laboratory data review and approval
  15. Trending of laboratory results

L. DATA INTEGRITY 

  1. Data integrity policy and awareness
  2. ALCOA+ principles implementation
  3. Audit trail review procedures
  4. Electronic signature compliance (21 CFR Part 11)
  5. User access management
  6. Password policies
  7. Data backup and recovery
  8. Standalone instrument data management
  9. Spreadsheet validation
  10. Chromatographic data system validation
  11. Raw data definition and protection
  12. Metadata management
  13. True copy procedures
  14. Hybrid system controls
  15. Data integrity risk assessments

M. REGULATORY COMPLIANCE

  1. Regulatory intelligence gathering
  2. Pre-submission meeting documentation
  3. IND/IMPD compilation process
  4. NDA/MAA dossier preparation
  5. CTD format compliance
  6. Regulatory commitment tracking
  7. Annual report preparation
  8. Post-approval change management
  9. Regulatory agency correspondence
  10. Global registration strategy

N. CLINICAL SUPPLIES 

  1. Clinical batch manufacturing
  2. Blinding and labeling procedures
  3. Clinical supplies packaging
  4. Randomization code management
  5. Comparator sourcing and testing
  6. Clinical supply chain management
  7. Temperature excursion handling
  8. Clinical batch release
  9. Expiry extension studies
  10. Reconciliation of clinical supplies

O. TECHNOLOGY TRANSFER 

  1. Technology transfer protocols
  2. Knowledge transfer documentation
  3. Sending site assessment
  4. Receiving site qualification
  5. Comparative batch analysis
  6. Equipment equivalence assessment
  7. Critical parameter transfer
  8. Analytical method transfer
  9. Gap analysis and remediation
  10. Technology transfer close-out reports

P. RISK MANAGEMENT 

  1. Quality risk management procedures
  2. Risk assessment tools (FMEA, HACCP, FTA)
  3. Risk prioritization matrix
  4. Risk mitigation strategies
  5. Residual risk evaluation
  6. Risk communication procedures
  7. Periodic risk review
  8. Product lifecycle risk assessment
  9. Supplier risk assessment
  10. Cross-contamination risk assessment

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