GDP Bootcamp©
The client, a sterile production facility of a multi national pharmaceutical company has received criticism by regulatory agencies for not following their SOPs and not documenting deviations from such SOPs and the QA organization of the client for failing to oversee the compliant execution of its Production Process Control Documentation, often referred to as batch records. As part of a bigger settlement with the regulatory agency, the client agreed to retrospective and prospective batch record review by a third party. The batch record review was performed by consultants of QORM LLC.
The expert reviewers soon noticed that the client had very tight documentation SOPs. It appeared they were the result of tightening the SOPs every time a “new” situation arose, a new exception was discovered or necessary, or a “new” type of issue with the documentation was discovered. The changes appeared to come so fast that there was a lot of confusion and frustration on both, the production floor, as well with the QA reviewers tasked with making the records compliant with regulations and SOPs.
Consultants of QORM engaged in several projects with the client to improve this situation. We convinced the client that, apart from many technical, content, and lay out changes to the batch record a “back to basics” approach to the understanding of Good Documentation Practices would be necessary. Out of this effort, the GDP Bootcamp © was born.
SOP
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Very specific
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Instructions based ( do this, don't do this)
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Regulatory requirement
Concept Based Training
Bootcamp
What guiding principles?
What is the purpose of GDP?
Increse ownership of GDP
Case Studies
Concept based training improves SOP based training
The 5 Principles of GDP
The GDP Boot Camp relies on 5 principles for compliant documentation, which are: Completeness, Accuracy, Clarity, Transparency, and Authentication. The Boto Camp posits that, if you follow these 5 principles, in most cases (if not all) you should have documentation that can withstand regulatory scrutiny.
These principles, in the case of our client, became part of the regular “lingo”. We often overheard QA specialists and manufacturing operators arguing their cases using exactly these terms, and not reverting to whether a particular case was discussed just like this in the documentation SOP or whether it presented “new” scenario that was NOT covered by the documentation SOP.
The 5 Principles of GDP
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Completeness
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Accuracy
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Clarity
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Transparency
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Authentication
If you follow these 5 prinicples you will be allright!
The Purpose of Documentation
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The FDA is the broker of trust between the patient and the manufacturer
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Documentation is the vehicule of information between the FDA and the manufacturer, allowing the FDA to endorse your product
The Purpose of Documentation
The purpose of documentation is to enhance the trust between the manufacturer and the patient (with the FDA being the broker between). Our experience was that this part resonated particularly well with operators who previously thought that “they just couldn’t get it right”. This part appeals to the professional pride of operators and QA reviewers, and helps them understand that this is not an us-vs-them game, but that – just like Product Quality itself – the documentation quality is the result of a mutual effort.
Like with many other things quality, there rarely is a true rejection of its value on the side of operators or QA personnel, but often there is a misunderstanding as to what the different roles entail. If the operator understands the value of documentation as part of product quality, he/she is more likely realize that QA, which is charged with ensuring compliance of documentation is part of a quality, and not an abusive process.
Mockup Examples to Enhance Understanding of 5 Principles
Before diving into case studies, a section of the training expands on the meaning of the 5 principles. Simple, mocked up examples are discussed, and the connection is drawn on why a certain behavior in documentation is necessary for any or all of the 5 principles be followed.
The examples would show typical real life examples as they have been observed by QORM batch record reviewers.
The purpose of this discussion is to understand certain documentation issues not as breaking with a particular SOP, but as breaking with the 5 principles. The course participants were asked to discuss remediations of the situation in terms of these 5 principles. An important realization of these discussions was that often there is more than one way of doing a correction with the 5 principles still being followed.
Anonymized Case Studies
A set of case studies derived from actual documentation is the basis for a detailed discussion. In these discussion, the participants analyze existing documentations with its flaws, and develop solutions in improving the documentation so that the 5 principles would be followed. They then defend their findings in front of the entire group. The discussions were always lively, and often revealed deeper issues with the setup of the documentation itself. These findings were reported to the client and incorporated in the remediation efforts. Most of all, though, the discussion improved the ownership of the learned content.
Measurable Success
The training was rolled out over a period of 6 month. In this time, the Right-First-Time ratio of records reviewed by QORM Consultants improved from below 50% to over 85%.
The trainign was rolled out to several 100 operators, QA analysts, and later Tech Services and Facilities staff. It routinely had approval rating of over 95%.
The output of the lively discussions enriched several remediation groups with tactical advice. But most of all, after about 1 month of training we started to notice that staff was using the 5 principles to argue documentation among each other and with the 3rd party reviewers.
Statistics provided using QORM's proprietary review and reporting software.