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.
3 Tips To Get The Best Bang For Your Mock Inspection Buck
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
About the Author

Penelope Przekop, CEO
Penelope Przekop is a is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial PV expertise. During the early 2000s, she developed and oversaw the first global PV quality and compliance departments established for Wyeth as well as Johson & Johnson. Her work includes qualification and oversight of numerous PV vendors covering all aspects of clinical safety and post-marketed PV. Penelope has facilitated numerous PV regulatory inspections. She frequently leads and conducts PV mock inspections and provides in-depth PV training.
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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.
On Jan. 31, 2024, the FDA, in collaboration with the Duke-Margolis Institute for Health Policy, convened a public workshop, Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches.
On Jan. 31, 2024, the FDA, in collaboration with the Duke-Margolis Institute for Health Policy, convened a public workshop, Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches.
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.
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.
Find out the reasons why our industry, your company, and employees should value the unique skillset of the quality and compliance professionals more than ever in decentralized pharma.
Find out the reasons why our industry, your company, and employees should value the unique skillset of the quality and compliance professionals more than ever in decentralized pharma.