Current Peptide Compliance

Establishing a quality management system from scratch can feel overwhelming, particularly for peptide startups and smaller compounding operations that lack dedicated regulatory staff. The good news: with the right framework and prioritization, you can build a functional, audit-ready QMS in 90 days.

Days 1-30: Foundation

The first month focuses on establishing your quality infrastructure. Define your quality policy and organizational structure, including the independence of your quality unit. Create your document control system — every SOP, form, and record you produce from this point forward needs a controlled home. Draft your core quality SOPs: document control, deviation management, CAPA, change control, and management review. These five procedures form the backbone of every effective QMS.

Days 31-60: Operations

Month two turns to operational procedures. Develop your manufacturing SOPs including batch production records, equipment qualification protocols, cleaning validation procedures, and environmental monitoring programs. Build your quality control procedures for incoming material testing, in-process controls, finished product release, and stability testing. Establish supplier qualification procedures and begin qualifying your critical material suppliers.

Days 61-90: Compliance and Launch

The final month addresses regulatory compliance and readiness. Implement your adverse event reporting system, complaint handling procedures, and recall procedures. Create your training program and begin qualifying personnel on critical SOPs. Conduct an internal audit against your complete system to identify gaps before any external scrutiny. Finally, hold your first management review to formally launch the QMS and establish your continuous improvement cycle.

Want to accelerate your QMS build? Current Peptide Compliance offers a 60+ SOP template package that cuts months off your implementation timeline. Learn more.