Any inaccuracies in Good Documentation Practice (GDP) can have an adverse impact on auditing process. Bhavan (Bob) Mehta, Principal Consultant and Recruiter, GMP ISO Expert Services, explains more about the need for GDP and its impact on auditing process in discussion with Sachin Jagdale
Why is it necessary to keep the written records of pharmaceutical operations?
For pharma operations regulated under 21 CFR Part 211 regulations, it is critical to maintain written records to serve as objective evidence during an audit to demonstrate that regulatory requirements were met and products manufactured are in strict compliance to cGMP norms. Some of the applicable requirements that require written records are 21 CFR Part 211.68, 211.180, 211.182, 211.192, and 211.198.
Which are the commonly observed errors in Good Documentation Practice (GDP)? How do they impact the auditing process?
Commonly observed errors in GDP are:
- Records are not filled accurately
- Over-writing
- Cross-outs without explanation or justification, initial and date
- Entries not made when tasks are performed
- Backdating
- Document is not legible and complete
- Records are approved by a second reviewer and errors are not identified during the review
- Use of white-out or correction tape
- Writing an explanation for one’s own understanding that can’t be understood by others
GDP is heart of the quality system. When records with any of the above errors are given to auditors, it proves that either the organisation has a lack of understanding of GDP requirements or does not have control over its quality system. When I say control over quality system, I mean a culture has not been created and supported by providing a robust training and identifying GDP-related issues during internal audits. A number of organisations have received warning letters for not having accurate and complete written records that are free of GDP errors.
What sort of training should pharma companies impart to their employees for the same?
Pharma companies should create a robust training programme to show how GDP directly impacts 21 CFR Part 211 regulations and share warning letters for learning and growth of their employees to minimise the number of errors. In addition, pharma companies should create a programme to qualify reviewers by providing extensive training to ensure that all GDP-related issues are identified by the primary and secondary reviewers. Lastly, organisations should train their internal auditors to focus on the areas of GDP by aligning requirements to the regulations (21 CFR Part 211).
What types of documents come under GDP?
The documents that should be considered for GDP are many. A few examples are manufacturing batch records, laboratory records, Out-of-Specification (OOS) investigations, cleaning logs, calibration logs, preventive maintenance logs, validation records, complaint and CAPA investigations.
Who is usually in-charge of GDP and what kind of qualification he/ she needs to have?
Each employee shall be in-charge of GDP. The goal of the pharma company should be to have “Zero GDP-related errors”. This is possible only when each employee fully understands the GDP requirements and takes ownership of tasks. The employee should understand that by saving five minutes, they are seeding a bad practice while not meeting regulatory requirements. Ultimately, leads and supervisors should provide resources, training, and create a culture where their departments support GDP. Qualification of the individual should be done by an expert who has experience working for the previous employer or supported FDA’s warning letter related remediation projects to fully understand how to establish a robust GDP programme and to be vigil by reviewing random records in addition to ensuring adherence to requirements during an internal audit.
Explain the role of technology in maintaining GDP.
The role of technology is critical. If an organisation can afford implementing electronic batch records rather than having a paper-based documentation system, it is a much more efficient way to tackle GDP-related issues. The system can detect fields not completed by an operator and requires the operator to complete the documentation accurately before submitting the document to the second reviewer. Electronic records also keep traceability of changes assuming that it is validated and compliant to 21 CFR Part 11 regulations.
Cite a few examples where pharma companies have been punished by regulatory authorities due to GDP related issues in India?
Many pharma companies in India received warning letters for not having a robust GDP programme which ultimately contributed to data integrity issues. For example, when using a paper-based system, if the operator intentionally or unintentionally does not enter critical information, the field can be filled by someone else on a later date and this creates a data integrity issue. Going back to 2014, a number of large and small pharma companies received warning letters from the FDA. A few of the companies are Cadila Healthcare, Sun Pharma, Sri Krishna, Micro Labs and Megafine Pharma. Since GDP and data integrity are inter-related, GDP issues require regulators to review additional records and organisations spend significant resources by flying in highly-skilled consultants from the US for remediation projects to meet the FDA commitments. In addition, FDA holds approval on new drugs until pharma companies fix issues fundamentally and submit evidences to the FDA. Lastly, pharma companies aren’t allowed to sell products to US customers before warning letter related remediation is completed. Altogether, it is a significant loss for pharma companies. As a result, senior management shall use a proactive approach rather than a reactive approach to avoid issues during regulatory inspections.