SOP Customization
Compounders and GMP facilities involved in aseptic or non-sterile drug production must maintain detailed, site-specific SOPs to meet state, federal, and accreditation requirements.
Off-the-shelf SOP templates may seem convenient—but they often fall short in inspections. Your procedures must align with your actual workflows, equipment, and personnel roles.
Restore Health Consulting customizes your SOPs to reflect your facility’s unique operations and to support compliance with:
State Boards of Pharmacy
FDA and DEA expectations
USP <797>, <795>, and <800>
Accreditation standards like PCAB and NABP
Why Leverage a Consultant for SOP Writing?
Whether you're preparing for an inspection or building a new program, we’ll ensure your documentation is defensible, compliant, and actionable.