How do you avoid common GMP documentation and record risks?

1 Risk 1: Incomplete or inaccurate documentation

One of the most common GMP documentation and record risks is having incomplete or inaccurate documentation. This can happen when you do not follow the standard operating procedures (SOPs) for documenting and recording your activities, when you do not update your documentation and records regularly, when you do not verify or review your documentation and records for accuracy and completeness, or when you do not correct or report any errors or discrepancies in your documentation and records. Incomplete or inaccurate documentation can compromise the quality and traceability of your products, as well as the integrity and credibility of your data and evidence. To avoid this risk, you should always follow the SOPs for documentation and record keeping, use approved templates and formats, use clear and consistent language and terminology, use only authorized signatures and dates, and ensure that your documentation and records are complete, accurate, legible, and current.

2 Risk 2: Unauthorized or improper access to documentation and records

Another common GMP documentation and record risk is having unauthorized or improper access to your documentation and records. This can happen when you do not have adequate security measures and controls in place to protect your documentation and records from unauthorized access, modification, deletion, or disclosure, whether they are in paper or electronic form. Unauthorized or improper access to your documentation and records can compromise the confidentiality and integrity of your information, as well as the reliability and validity of your data and evidence. To avoid this risk, you should always follow the SOPs for access and authorization of documentation and records, use secure storage and backup systems, use passwords and encryption methods, use audit trails and logs, and ensure that your documentation and records are accessible only to authorized personnel and for authorized purposes.

3 Risk 3: Inconsistent or non-compliant documentation and record practices

A third common GMP documentation and record risk is having inconsistent or non-compliant documentation and record practices. This can happen when you do not have a clear and comprehensive documentation and record management system in place, when you do not follow the applicable regulations and standards for documentation and record keeping, when you do not have adequate training and awareness programs for your staff, or when you do not have effective monitoring and evaluation mechanisms for your documentation and record performance. Inconsistent or non-compliant documentation and record practices can compromise the compliance and quality of your products, as well as the reputation and trust of your customers and regulators. To avoid this risk, you should always follow the SOPs for documentation and record management, use a document control system, use a record retention and disposal policy, follow the relevant regulations and standards for documentation and record keeping, provide regular training and awareness programs for your staff, and conduct periodic audits and reviews of your documentation and record performance.

4 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?