Standard operating procedures (SOPs) have become the documentation backbone of our industry and, yes, at times, a major pain in the neck. Those of us who were around during the 80s may be able to recall fuzzy memories of SOPs being a thing . Fast forward to 2019, past the birth of ICH, the evolution of outsourcing, the techno explosion and the FDA’s 21 CFR Part 11, the EU obsession with quality systems, and the more recent rise of the big vendor. Today, we’re buried in mountains of SOPs.

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When it comes to GCP audits and inspections, low-hanging fruit says a lot about the tree. Welcome to the mind of an auditor/inspector. I’m going to share the thought process auditors and inspectors commonly use while reviewing job descriptions, CVs, and organizational (org) charts. Ensuring these documents are in tip-top shape is a no-brainer given the high odds they will be requested and reviewed. While establishing excellent processes for SOP and training documentation and maintenance can be complex, updating job descriptions, CVs, and org charts is perhaps one of the simplest processes within the quality system.

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Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.

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Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. Many have exciting products with fantastic preclinical and/or clinical results, great platforms for long-term company growth and licensing possibilities, outstanding medical and technical expertise, and support from intellectual/academic experts. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.

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