Documentation and Quality Systems: Success is in the Details!

As a consultant, I work with a variety of pharmaceutical and biotech companies in many different stages of drug development. Some companies are trying to get their first drug into the clinic, while others are working on their first marketing approval. In the current industry environment, an increasing amount of work is outsourced as companies become leaner and more virtual with a razor focus on delivering a new drug or technology to patients. Contract manufacturing organizations of all shapes and sizes have sprung-up to handle the constant flow of novel technologies emerging to help fight a myriad of diseases. With all this novelty, innovation, and push to move forward, some basics are getting overlooked.

Documentation is an area that has taken a hard hit as scientists are more focused on PowerPoint presentations than reports. As a result, critical experiments and procedures are not recorded in the level of detail necessary to be reproduced or fully understood, or for the proper conclusions to be reached. You may think a PowerPoint presentation is sufficient, but consider this: after a year or two or longer, when the employee has departed the company or a potential partner is reviewing the documents as part of due diligence, will a PowerPoint presentation, a few notebook pages, and a spreadsheet be enough?

Quality Systems is another area that is often overlooked. Companies working on the licensing application may have well developed quality systems and groups, but often times there is considerable variation in these systems, and companies in earlier stages of development are not always able to implement fully functioning groups in the time needed. The FDA and EMA have made it clear that even virtual companies are required to have Quality Systems, with an explicit requirement written into the US CFR in 2012. In January 2015, the FDA launched its own Office of Pharmaceutical Quality to create a single, unified division with quality responsibility. I met recently with a new client who was more than a year from filing their IND. The client had hired their Director of Quality and was drafting SOPs. I complimented them on their forward thinking because I felt they were ahead of the curve. They replied that they were concerned they had not started soon enough!

Documentation and Quality Systems are intertwined, and it’s best to put these areas in place early, well before you are looking at submitting your IND, making your first batch of cGMP material, or gathering documents for diligence. These are busy and stressful times, but if you take the time early on to ensure that your company has organized, complete, and reviewed documentation, you’ll thank yourself, and your employees, potential partners, and reviewers will thank you too!

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