AI Checklist Generator

From the makers of Manifestly Checklists

Email address

Home > Manufacturing > Pharmaceutical Facility Gap Analysis Checklist

Pharmaceutical Facility Gap Analysis Checklist

Facility Overview

Identify the facility location and type (e.g., GMP, non-GMP).

Review facility layout and design.

Assess facility age and condition.

Regulatory Compliance

Verify compliance with FDA regulations.

Confirm adherence to EMA guidelines.

Check for compliance with ICH Q7 guidelines.

Review documentation of previous inspections and findings.

Quality Management System

Evaluate the Quality Management System (QMS) in place.

Assess the effectiveness of change control procedures.

Review deviation and CAPA (Corrective and Preventive Action) processes.

Check for ongoing training programs for personnel.

Production Processes

Assess the manufacturing processes for compliance with SOPs (Standard Operating Procedures).

Evaluate equipment qualification (IQ, OQ, PQ).

Review batch record accuracy and completeness.

Check for contamination controls and practices.

Laboratory and Testing Facilities

Evaluate laboratory compliance with GLP (Good Laboratory Practices).

Review equipment calibration and maintenance records.

Assess the validation of analytical methods.

Check for appropriate sample management procedures.

Documentation and Record Keeping

Review document control practices.

Assess the accuracy and accessibility of records.

Verify retention policies for records and documents.

Check for electronic records compliance with 21 CFR Part 11.

Training and Personnel

Assess training programs for all staff.

Review training records for compliance and completeness.

Evaluate personnel qualifications and certifications.

Check for ongoing professional development opportunities.

Environmental Controls

Evaluate HVAC systems for proper functioning.

Assess cleanroom classifications and monitoring.

Check for environmental monitoring programs.

Review waste management and disposal practices.

Risk Management

Assess risk management strategies in place.

Review risk assessments for critical processes.

Check for implementation of risk mitigation measures.

Evaluate business continuity and disaster recovery plans.

Supplier and Vendor Management

Review supplier qualification processes.

Assess vendor audits and performance evaluations.

Check for compliance with supplier agreements and contracts.

Evaluate the management of raw materials and components.

Final Review and Reporting

Compile findings from all sections of the checklist.

Identify key gaps and areas for improvement.

Prepare a comprehensive gap analysis report.

Schedule a follow-up meeting to discuss findings with stakeholders.

This checklist provides a structured approach for conducting a gap analysis in pharmaceutical facilities, ensuring that all critical areas are covered for compliance and operational efficiency.

Download CSV Download JSON Download Markdown

Use in Manifestly

Related Checklists

Inventory Management

Inventory Management is essential for monitoring and controlling the stock levels of materials and products in order to optimise production, reduce costs, and improve customer service.

view →

Shipping and Receiving Checklist

A Shipping and Receiving Checklist is important to ensure accuracy, quality control, and timely delivery of products.

view →

Employee Termination

Employee termination is important for maintaining a workplace environment that is safe, productive, and free from disruption.

view →

Regulatory Compliance

Regulatory compliance is essential for ensuring that manufacturers produce safe products that meet industry and government standards.

view →

Production Planning

Production Planning is essential for optimizing resources and ensuring efficient production of goods and services.

view →

Equipment Maintenance Checklist

Equipment Maintenance Checklist helps to ensure that manufacturing equipment is properly maintained and operating at optimal levels for maximum efficiency and productivity.

view →

Employee Onboarding

Employee Onboarding is essential to ensure that new hires are quickly integrated into the organization and enabled to become productive contributors to the team.

view →

Performance Evaluation Checklist

Performance Evaluation Checklists help to ensure that all manufacturing processes are running efficiently and effectively, and that any potential issues are identified and addressed quickly.

view →

Quality Assurance

Quality Assurance ensures that products and services meet customer standards and expectations.

view →

Environmental Compliance

Environmental Compliance ensures that the manufacturing process does not harm the environment or put the health and safety of employees and communities at risk.

view →

Workplace Safety Checklist

A Workplace Safety Checklist is an essential tool for ensuring a safe and productive work environment for employees.

view →

Employee Training Checklist

Employee Training Checklists are important tools to ensure employees are properly trained in safety, quality and job-specific skills.

view →

Hey there! Here's a little about us or visit our recurring workflow SaaS: Manifestly Checklists

Light Dark