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August 2011

David Dills

Writing and Enforcing Your SOP for GxP Compliance Success - Part 2

by David R. Dills
Quality & Compliance Advisor

Writing and developing solid operational procedures is a skill that develops over time. Procedures are usually fairly technical and often describe complex subjects. These procedures are reviewed by subject-matter experts, as well as by internal and external auditors and by employees at all levels of the organization. Therefore, it is important to consider the language used when communicating an idea.

Terms like "must," "shall," and "will" indicate steps within a procedure that must be adhered to exactly with each execution. Avoid words that cause ambiguity. Words such as "periodically," "generally," "may," "should," and "can" typically indicate a preference and do not enforce consistent execution.

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Marie McKenzie Mills

Is There a Legal Requirement to Have SOPs for GCP in Europe?

by Dr. Marie McKenzie Mills
MICR, CSci, CBiol, MSB

Before addressing whether there's a European requirement for Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP), we need to consider whether ICH GCP (i.e. as provided by the International Conference on Harmonisation) remains the international standard following the publication of the Clinical Trials Directive (2001/20/EC) and the GCP Directive (2005/28/EC). Why? Mainly because the Clinical Trials Directive did not explicitly mention ICH GCP, leading to the perennial question of: which GCP should we be following? So here goes my answer, particularly for those of us affected by European legislation, with a wee bit of context to explain it.

In Europe, the principles of Good Clinical Practice were adopted in July 1996, and became operational in January 1997. These principles were laid down in the community guideline: Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), otherwise known as ICH Topic E 6 (R1) Guideline for Good Clinical Practice or ICH GCP. Despite having no uniform legal framework for implementation, ICH GCP was largely adhered to within the European Community (EC) as a set of 13 internationally recognised principles for conducting clinical trials. In turn, these were founded in the bioethical principles established in the Declaration of Helsinki. But, its adoption as a regulatory standard was neither complete nor uniform.

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According to Carl Anderson, Regulatory and Compliance Consultant, "FDA has issued a new draft guidance document on medical device clinical trials to support a Pre-Market Approval application (PMA). Approximately 30 percent of FDA regulated clinical trials are for medical devices and are regulated by the IDE regulations (21 CFR 812). The remaining 70 percent are for drugs and biologics and are regulated by the IND regulations (21 CFR 312)."
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