AI Checklist Generator

From the makers of Manifestly Checklists

Email address

Home > Consulting > GMP Checklist

GMP Checklist

General Requirements

Ensure compliance with relevant GMP regulations and guidelines

Establish a Quality Management System (QMS) to manage GMP activities

Appoint a designated person responsible for GMP compliance

Maintain appropriate documentation for GMP procedures and records

Conduct regular internal audits to assess compliance with GMP requirements

Implement a training program to educate employees on GMP principles and practices

Personnel

Verify that personnel have appropriate qualifications and training for their assigned tasks

Document and maintain records of personnel training and qualifications

Provide ongoing GMP training and development opportunities for employees

Establish procedures for handling personnel hygiene and health requirements

Implement a gowning and personal protective equipment (PPE) policy as per GMP guidelines

Facilities and Equipment

Ensure that facilities are designed, constructed, and maintained to meet GMP standards

Establish procedures for cleaning and maintenance of facilities and equipment

Conduct regular calibration and validation of equipment as required

Implement a system for handling and controlling non-conforming equipment or facilities

Develop procedures for environmental monitoring and control within the facilities

Documentation and Records

Establish a document control system to manage GMP-related documents

Develop and maintain standard operating procedures (SOPs) for all GMP activities

Implement a change control process for managing revisions to GMP-related documents

Retain and archive GMP records as per regulatory requirements

Conduct periodic reviews of documentation and records to ensure accuracy and completeness

Production and Process Controls

Establish procedures for batch record review and approval

Implement controls for the handling, storage, and use of starting materials

Develop and maintain a system for product and process validation

Implement appropriate measures for preventing cross-contamination during production

Establish procedures for managing deviation, investigation, and CAPA (Corrective and Preventive Actions) processes

Quality Control

Establish a laboratory control system to ensure accurate and reliable test results

Implement procedures for sampling, testing, and release of finished products

Develop specifications for raw materials, intermediates, and finished products

Conduct regular stability studies to ensure product quality over time

Establish procedures for managing out-of-specification (OOS) results and product recalls

Packaging and Labeling Control

Establish controls for labeling and packaging materials to ensure product integrity

Implement procedures for inspection and approval of labeling and packaging materials

Develop and maintain labeling and packaging specifications

Conduct regular checks to ensure accurate and compliant product labeling

Establish procedures for managing packaging errors or deviations

Supplier and Contractor Management

Establish a system for evaluating and approving suppliers and contractors

Develop and maintain supplier qualification documentation and records

Conduct regular audits of suppliers and contractors to ensure compliance with GMP

Implement procedures for managing supplier or contractor non-conformances

Establish a process for handling and documenting supplier or contractor changes

Complaints and Product Recall

Establish a system for receiving, documenting, and investigating customer complaints

Develop procedures for managing product recalls or withdrawals, if required

Implement a complaint handling process to ensure timely resolution and appropriate actions

Establish a mechanism for trending and analyzing complaint data to identify potential quality issues

Conduct regular reviews of complaint and recall data for continuous improvement purposes

Continuous Improvement

Implement a system for tracking and trending quality metrics and key performance indicators

Establish procedures for conducting management reviews to assess overall GMP performance

Develop a process for implementing and tracking corrective and preventive actions

Encourage employee involvement in identifying and implementing process improvements

Conduct regular GMP training and awareness programs to reinforce a culture of continuous improvement.

Download CSV Download JSON Download Markdown

Use in Manifestly

Related Checklists

Employee Orientation Checklist

A well-designed Employee Orientation Checklist helps to ensure that new employees receive a comprehensive introduction to the company and their job duties.

view →

Client Onboarding Checklist

A Client Onboarding Checklist is essential for ensuring a smooth and successful transition of new clients into a consulting engagement.

view →

Leave of Absence Checklist

A Leave of Absence Checklist is important to ensure that all necessary steps are taken to properly document and process employee absences.

view →

Performance Evaluation Checklist

Performance Evaluation Checklists are essential for measuring an employee's performance and providing feedback to ensure they are meeting the expectations of their role.

view →

Project Kickoff Checklist

A Project Kickoff Checklist is essential to ensure that all stakeholders are on the same page and that all project objectives and expectations are clearly defined.

view →

Data Security Checklist

A Data Security Checklist is an essential tool to ensure that an organization's data is secure and protected from unauthorized access.

view →

Employee Termination Checklist

A Employee Termination Checklist ensures all necessary steps are taken to ensure a smooth and compliant termination process.

view →

Risk Management Checklist

A Risk Management Checklist is a tool to help identify, assess, and manage potential risks to an organization and its stakeholders.

view →

Client Offboarding Checklist

The Client Offboarding Checklist is critical for ensuring a successful and thorough transition process, ensuring that all stakeholders are informed and any outstanding issues are resolved.

view →

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

Light Dark