GMP Process Design and Implementation

From Receiving to Shipping, Systems That Fit

From receiving of ingredients to making and shipping product out the door, we set up the simple systems your team needs to operate with ease and confidence. That means SOPs written for your actual operation rather than someone else's template, batch records your operators can complete correctly the first time, and a quality management system sized to your company instead of a binder built for a corporation ten times your size.

• Custom SOP development for your operation
• Quality management system design and setup
• Batch record and documentation templates
• Staff training on new systems and procedures

Implemented With Your Team, Not Handed Over

We do not hand over a stack of documents and disappear. We stay through implementation, train your staff on the new procedures, and adjust the systems based on how they perform on your floor. Process design usually begins with a GMP gap assessment so the build addresses your real gaps, and it pairs naturally with our GMP training programs when your whole team needs to come up to speed.

Common Questions

Do you write SOPs for us or with us?

Both, depending on what you need. We draft custom SOPs built around your actual operation, then refine them with your team so the procedures describe work the way it really happens. We train your staff on every system we set up.

Can you build a quality system from scratch?

Yes. For startups setting up their first FDA-regulated facility, we design the complete system: quality manual, SOPs, batch records, training program, and document control, scaled to your size and product type.

Which industries do you design processes for?

Cosmetics, dietary supplements, food, medical devices, and drugs and pharmaceuticals, with every workflow tailored to your products and the regulations that apply to them.