What's the best way to prepare GMP documentation and records for inspections?

1 Define the scope and purpose

The first step to prepare GMP documentation and records for inspections is to define the scope and purpose of the inspection. This will help you identify the relevant documents and records that you need to review, update, and organize. Depending on the type and level of inspection, you may need to provide different kinds of documentation and records, such as standard operating procedures (SOPs), batch records, validation reports, quality manuals, training records, deviation reports, corrective and preventive actions (CAPAs), audit reports, and so on. You should also understand the objectives and expectations of the inspector, and the criteria and guidelines that they will use to evaluate your documentation and records.

2 Review and update your documentation and records

The next step is to review and update your documentation and records to ensure that they are accurate, complete, and consistent. You should check for any errors, gaps, discrepancies, or outdated information in your documents and records, and make the necessary corrections or revisions. You should also verify that your documentation and records are aligned with the current standards and regulations, as well as your internal policies and procedures. You should document any changes or updates that you make, and obtain the appropriate approvals and signatures.

3 Organize and label your documentation and records

The third step is to organize and label your documentation and records to make them easy to access and retrieve. You should have a clear and logical system for storing, indexing, and categorizing your documents and records, such as by product, process, department, or function. You should also use consistent and descriptive labels, titles, and codes for your documents and records, and include relevant information such as dates, versions, authors, reviewers, and status. You should also ensure that your documentation and records are protected from unauthorized access, modification, or damage, and that you have backups or copies in case of loss or damage.

4 Prepare a summary and a checklist

The fourth step is to prepare a summary and a checklist of your documentation and records for inspections. A summary is a brief overview of your documentation and records, highlighting the main points, features, or achievements. A checklist is a detailed list of your documentation and records, indicating their location, format, and availability. A summary and a checklist can help you communicate and demonstrate your compliance status to the inspector, and also help you identify and address any missing or incomplete documentation or records before the inspection.

5 Train and brief your staff

The fifth step is to train and brief your staff on how to handle documentation and records for inspections. Your staff should be familiar with the scope and purpose of the inspection, and the documentation and records that are required. They should also know how to access, present, and explain your documentation and records to the inspector, and how to answer any questions or requests that they may have. You should also train and brief your staff on how to follow the GMP principles and practices, such as data integrity, document control, change management, quality management, and risk management.

6 Monitor and follow up

The final step is to monitor and follow up on the inspection process and the inspection results. You should keep track of the documentation and records that are reviewed, requested, or sampled by the inspector, and document any feedback, comments, or findings that they may provide. You should also follow up on any issues, deficiencies, or non-conformities that are identified by the inspector, and provide the necessary documentation or records to support your corrective or preventive actions. You should also maintain a record of the inspection outcome, such as a report, a certificate, or a letter of compliance.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?