Standard Operating Procedures (SOPs)

We have extensive experience with GMPs, GCPs, GLPs, and SOPs.

Before writing cGMPs, ICH compliant SOPs, we review the current workflow of clinical supply processes and/or establish new processes.  These streamlined processes reduce in-efficiencies and maximize productivity.  The SOPs can then be written to capture the "real" processes of your staffs daily activities.

We can use our standardized template for SOPs or our clients template.

Our SOP template includes:

  Ø      Purpose

Ø      Scope

Ø      Responsibilities

Ø      Procedures

Ø      References

Ø      Attachments (if applicable)

Ø      Revision History

We ensure annual review of our SOPs and annual training of SOPs.

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