Audit Checklist for Quality Assurance Department in Pharmaceutical
🔍
Audit Checklist for Quality Assurance Department in Pharmaceutical
Explore our efficient audit checklist designed for Quality Assurance in the pharmaceutical sector, ensuring compliance, safety, and superior standards.
1
Review Quality Management System (QMS) documentation
2
Verify adherence to International Organization for Standardization (ISO) standards
3
Inspect equipment and machinery for cleanliness and functionality
4
Approval: Equipment Inspection
5
Check the quality and safety of raw materials
6
Verify proper material handling and storage
7
Inspect production process for compliance with Good Manufacturing Practices (GMP)
8
Approval: Production Process Inspection
9
Verify accuracy and completeness of batch records
10
Check the validation of critical processes
11
Examine training records and competencies of personnel
12
Check for valid calibrations of measuring and testing equipment
13
Review Corrective and Preventive Actions (CAPA)
14
Review records of product recalls and customer complaints
Inspect final product testing, release and control records
18
Review supplier evaluation and approval records
19
Approval: Supplier Evaluation Review
20
Evaluate risk management procedures
Review Quality Management System (QMS) documentation
Review the documentation related to the Quality Management System (QMS) in a friendly tone. Understand the role of this task in ensuring quality and compliance. Discuss the desired results of the review, potential challenges, and provide guidance on the required resources or tools. Use varying sentence structures and ask leading questions to keep the description engaging.
1
Quality Manual
2
Standard Operating Procedures
3
Work Instructions
4
Forms
5
Training Records
Verify adherence to International Organization for Standardization (ISO) standards
Highlight the importance of adhering to ISO standards and the impact it has on the organization. Encourage teams to ensure compliance and discuss potential challenges and their remedies. Ask questions that prompt thinking about the processes involved. Provide any relevant guidance or resources.
1
9001
2
14001
3
45001
4
27001
5
50001
Inspect equipment and machinery for cleanliness and functionality
Explain the significance of inspecting equipment and machinery in the pharmaceutical industry. Describe the potential impact of unclean or malfunctioning equipment on quality assurance. Provide suggestions for ensuring cleanliness and functional efficiency, and discuss how to report any issues found during inspection.
1
Cleanliness
2
Functionality
3
Maintenance
4
Calibration
5
Safety
Approval: Equipment Inspection
Will be submitted for approval:
Inspect equipment and machinery for cleanliness and functionality
Will be submitted
Check the quality and safety of raw materials
Discuss the importance of checking the quality and safety of raw materials used in pharmaceutical manufacturing. Explain how this task contributes to ensuring compliance with quality standards and patient safety. Provide guidance on how to perform the checks and any specific resources that may be needed.
1
Appearance
2
Purity
3
Identity
4
Storage
5
Expiration Date
Verify proper material handling and storage
Emphasize the significance of proper material handling and storage in maintaining product quality and safety. Describe the potential impact of improper handling or storage practices. Provide guidance on how to verify proper handling and storage, and suggest any specific resources or tools that may be required.
1
Temperature Control
2
Chemical Segregation
3
Proper Labeling
4
Inventory Management
5
Contamination Prevention
Inspect production process for compliance with Good Manufacturing Practices (GMP)
Explain the importance of inspecting the production process for compliance with Good Manufacturing Practices (GMP). Discuss the potential implications of non-compliance. Provide guidance on conducting the inspection, including specific areas to focus on and any required resources or tools.
1
Sanitation
2
Documentation
3
Training
4
Validation
5
Change Control
Approval: Production Process Inspection
Will be submitted for approval:
Inspect production process for compliance with Good Manufacturing Practices (GMP)
Will be submitted
Verify accuracy and completeness of batch records
Highlight the importance of verifying the accuracy and completeness of batch records. Explain how this task ensures traceability, regulatory compliance, and the production of high-quality products. Provide guidance on the verification process and any specific challenges to watch out for.
1
Product Identification
2
Raw Material Usage
3
Process Parameters
4
Quality Control Results
5
Signatures
Check the validation of critical processes
Describe the role of validating critical processes in ensuring consistent product quality. Emphasize the potential risks associated with unvalidated processes. Provide guidance on how to perform the validation check and any specific resources or tools that may be required.
1
Risk Assessment
2
Protocol Execution
3
Data Analysis
4
Report Preparation
5
Corrective Actions
Examine training records and competencies of personnel
Explain the importance of examining training records and personnel competencies. Discuss how this task contributes to ensuring a qualified workforce capable of maintaining quality standards. Provide guidance on conducting the examination and any specific challenges to consider.
1
Training Records
2
Certifications
3
Skills Assessments
4
Performance Evaluations
5
Training Needs Analysis
Check for valid calibrations of measuring and testing equipment
Describe the significance of checking for valid calibrations of measuring and testing equipment. Discuss the potential impact of inaccurate measurements or faulty equipment on product quality. Provide guidance on how to perform the checks and any specific resources or tools that may be needed.
1
Scales
2
Thermometers
3
Pressure Gauges
4
pH Meters
5
Spectrophotometers
Review Corrective and Preventive Actions (CAPA)
Highlight the importance of reviewing Corrective and Preventive Actions (CAPA) in maintaining continuous improvement. Discuss how this task contributes to identifying and resolving potential issues. Provide guidance on how to conduct the review effectively and any specific challenges to consider.
1
Root Cause Analysis
2
Effectiveness Evaluation
3
CAPA Implementation
4
Risk Mitigation
5
Documentation Compliance
Review records of product recalls and customer complaints
Explain the significance of reviewing records of product recalls and customer complaints. Discuss how this task contributes to identifying patterns, improving processes, and ensuring customer satisfaction. Provide guidance on how to conduct the review and any specific resources or tools that may be needed.
Emphasize the importance of verifying internal self-inspection (audit) procedures to ensure compliance with regulations and industry standards. Discuss how this task contributes to identifying areas for improvement and preventing non-compliance. Provide guidance on how to perform the verification and any specific challenges to consider.
1
Audit Planning
2
Documentation Review
3
Process Analysis
4
Personnel Interviews
5
Non-Conformance Classification
Inspect final product testing, release and control records
Describe the importance of inspecting final product testing, release, and control records. Discuss how this task contributes to ensuring product quality and regulatory compliance. Provide guidance on how to conduct the inspection effectively and any specific challenges to consider.
1
Product Specifications
2
Batch Release Documentation
3
Stability Testing Results
4
Quality Control Analysis
5
Quality Records
Review supplier evaluation and approval records
Explain the significance of reviewing supplier evaluation and approval records. Discuss how this task contributes to ensuring the reliability and quality of raw materials. Provide guidance on how to conduct the review and any specific challenges to consider.
1
Supplier Qualification
2
Quality Certifications
3
Audit Findings
4
Raw Material Testing
5
Compliance Documentation
Approval: Supplier Evaluation Review
Will be submitted for approval:
Review supplier evaluation and approval records
Will be submitted
Evaluate risk management procedures
Describe the importance of evaluating risk management procedures in the pharmaceutical industry. Discuss how this task contributes to identifying and mitigating potential risks. Provide guidance on how to perform the evaluation effectively and any specific challenges to consider.
