Standard Operating Procedures (SOPs)

QC2 offers the following Standard Operating Procedure (SOP) services, which are customized for your specific project and budget needs:

SOP Gap Analysis

Gap analysis of SOPs, work instructions, and associated documents to assess compliance with current regulatory requirements as applicable, including 21 CFR Parts 11, 50, 54, 56, 58, 312, and 314, and ICH GCP guidelines, as well as to provide comparison against industry standards and best practices.  Feedback is provided for workflow improvements and  additional quality measures, best practices, or changes needed to meet regulatory requirements are identified.

SOP Review and Revision

Review and revision of SOPs to ensure compliance with GCPs, GLPs, cGMPs, ICH guidelines, and current industry standards and best practices, and also to confirm SOPs reflects current processes.

SOP Preparation

Preparation of new SOPs and framework for SOP systems that are compliant with GCPs, GLPs, cGMPs, applicable regulations, and ICH guidelines, and reflect current industry standards and best practices.