There are four simple sentences that define the concept of compliance and its relationship to Standard Operating Procedures (SOPs) — Say what you do. Do what you say. Prove it. Improve it.
Despite this concept seeming simple, the number one topic of 483 observations for biologics, drugs, and devices from 2013 through 2017 included failure to follow SOPs, procedures not in writing, and lack of adequate procedures.
In this comprehensive guide, gain practical insight into the need for SOPs, how to write them, and what should be included in them. Explore the application of SOPs to the pharmaceutical, biotechnology, and medical device industries. This useful text offers a simple, yet, straight forward approach to writing SOPs, highlighting their importance in maintaining compliant operations critical to manufacturing quality products.
Upon finishing this book, you'll be able to not only write out SOPs but also follow them to fully maintain compliance.
Table of Contents:
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- Introduction: What is an SOP and Why Do We Write Them?
- Regulatory Requirements for SOPs
- Defining the Requirements of SOPs
- Seven Essential Elements of SOPs
- Avoiding Pitfalls in SOPs
- Additional Considerations for SOPs
About the Authors
Susan Schniepp has 37 years' experience in Quality Assurance. She is a Distinguished Fellow with Regulatory Compliance Associates Inc. advising clients on overall Quality and Compliance strategies. As an active member of PDA, Sue currently serves on the Board of Directors and has been a member of the PDA/FDA Joint Regulatory Conference since 2001. Sue is currently Past Chair of PDA's Regulatory Affairs/Quality Advisory Board, chairing the group from 2012-2015.
Brian Matye, CEO, Regulatory Compliance Associates Inc. Brian Matye's career spans over 25 years in senior engineering leadership roles at Baxter, GE Healthcare and Medtronic, with experience in all phases of high reliability systems, medical product development and deployment, life cycle management, quality assurance and project management.
Jeanne Moldenhauer, Excellent Pharma Consulting, has more than 25 years of experience in the pharmaceutical industry. She chairs the Environmental Monitoring/Microbiology Interest Group of PDA, serves on the Scientific Advisory Board of PDA, founded the Rapid Microbiology Users Group ™ and is a member of ASQ and RAPS. She is the author of several texts published by PDA/DHI and numerous articles published in industry journals.