Building Your First Quality Management System for GMP Compliance

If you’ve been following along in this series, you already know what GMP is and why it matters. We also talked about how building a strong GMP culture helps new manufacturers stay consistent, confident, and inspection-ready as they grow.

The next practical question becomes: “Where do we actually start?”

This is where a structured Quality Management System (QMS) provides the necessary framework. A QMS doesn’t need to be complex or expensive to be effective. However, it does need to be comprehensive and most importantly, followed.

This article walks through how new manufacturers can build a practical, paper-based QMS that meets GMP expectations and works to simplify and standardize procedures that will inevitably improve and streamline your operations.

What a QMS Really Is (and What It Isn’t)

At its core, a Quality Management System is a set of documented processes and controls a company uses to consistently make safe, compliant products and meet FDA requirements. It defines how work is done, how quality is confirmed, and how issues are identified, corrected, and prevented.

It’s not:

• A single binder you pull out for inspections
• A one-time project
• Something that only involves Quality

A working QMS shows up in everyday operations. It connects procedures, training, records, and accountability into one system that supports safe, consistent manufacturing.

FDA regulations across industries— pharmaceuticals, dietary supplements, OTCs, and cosmetics, etc.—expect manufacturers to have written procedures, trained personnel, and records that demonstrate control. A well-developed QMS is how these expectations come together in an organized way.

Start with Documents—but Don’t Get Stuck There

Most companies begin their QMS by writing procedures, and that’s the right place to start. Standard Operating Procedures (SOPs), batch records, specifications, and logs create the structure your system will rely on.

The key is how you approach them.

Before approving initial documents:

• Review them carefully with necessary department heads to get input and make edits
• Dry-run operational procedures and batch records
• Walk through them on the floor to see what works and what doesn’t

It’s much easier to make changes before approval than after. That said, waiting for perfection can stall progress entirely. Your change process exists so documents can evolve as your operation grows.

Starting matters more than starting perfectly.

Approving, Training, and Actually Using Your Procedures

Once documents are ready, they need to move through approval and then into real use.

A practical approach:

• Approve related documents in manageable groups
• Train relevant team members before use
• Put procedures into action

One of the most common inspection findings comes from companies that have approved procedures but don’t actually follow them. Inspectors aren’t looking for beautiful binders—they’re looking for alignment between what’s written and what’s happening.

If you create a procedure, train it. If you train it, use it. And once it’s in use, stay consistent.

Paper-Based Systems Can Work—When They’re Organized

Not every manufacturer needs electronic QMS software to be compliant. Many early-stage companies successfully operate paper-based systems when they’re well controlled.

A few best practices:

• Keep original signed documents in organized binders
• Scan approved documents and store them as PDFs
• Mirror your binder structure in electronic folders
• Password-protect controlled forms and logs

Common binder categories often include:

• SOPs
• Change requests
• Quality records
• Materials and suppliers
• Labels and packaging
• Batch records by product
• CAPAs, deviations, and complaints

What matters most is that documents are controlled, accessible, and consistently used.

Assign Ownership Early

A QMS doesn’t manage itself. One of the smartest moves a company can make early on is assigning clear ownership.

This doesn’t mean one person does everything but someone needs to be responsible for:

• Driving documents through the approval and/or change control progress
•  Coordinating training
• Tracking changes and follow-ups

This role is often referred to as a QMS Champion. Without ownership, even well-written systems tend to stall.

Leadership alignment matters here as well. When management supports the system and follows the same procedures as everyone else, the message is clear: quality isn’t optional.

Using Drafts the Right Way

When rolling out new batch records or operational documents, many companies benefit from using a draft alongside the original.

Here’s how that works:

• Use the approved version for actual documentation
• Use the draft copy to capture notes and improvements
• Revise the draft until it’s ready for formal approval

This approach allows teams to learn and refine without losing compliance or traceability.

What Inspectors and Auditors Expect to See

Whether you’re preparing for an FDA inspection or a third-party GMP audit, expectations are consistent across industries.

Inspectors want to see:

• Procedures that reflect real operations
• Evidence that employees are trained
• Records that show the system has been in use over time
• A functioning change process

If certification is the goal, auditors typically expect to see about three months of active system use before an audit. That’s why starting early matters—waiting until an inspection is scheduled is often too late.

FDA guidance emphasizes that quality systems should support continuous improvement, not just compliance on paper. A QMS that evolves based on real data, deviations, and feedback is a strong system

A Realistic Timeline for New Manufacturers

Building a functional QMS takes time, and that’s normal.

A typical progression looks like this:

Months 1–3

• Develop, review and approve SOPs
• Train staff
• Qualify suppliers
• Develop and adopt specifications and master manufacturing records

Months 4–6

• Conduct internal audits
• Address gaps and trends
• Perform management review
• Prepare for GMP certification or inspection

Most companies reach a stable, inspection-ready system within six to twelve months, depending on complexity and available resources.

To support this process, we’ve created a practical implementation guide that walks through:

• Document preparation and approval
• Paper-based storage best practices
• Ownership and rollout tips
• Common pitfalls to avoid

This guide is designed for real teams building real systems that work with for their business.

Download the QMS Implementation Tips Guide to use alongside this article as you build or refine your Quality Management System

You Don’t Have to Build It Alone

A Quality Management System is one of the most important foundations a manufacturer will put in place. When done well, it supports growth, protects your product, and builds confidence across your organization.

At cGMP Consulting, we help manufacturers turn GMP requirements into systems that work in everyday operations. We work with clients that are starting from scratch and those that are enhancing an existing system, we meet you where you are and help you move forward with minimal disruption to your business.

If you’re ready to build a QMS that supports compliance without slowing you down, we’re here to help. Contact us today so we can help you on your journey.