Quality Commitment
Quality Is Built Into Our DNA — Not Added at the End
At MediCraft, quality is not a department — it's the operating philosophy of every person in our building. We've assembled a leadership team whose combined experience in pharmacy regulation, compliance, and formulation science gives us a foundation that most compounding pharmacies spend years trying to build.
Where We Stand
Accreditation, Stated Plainly
Four standards, and exactly where MediCraft sits against each one today.
PCAB Accreditation — Actively In Progress
We are currently working through the formal PCAB accreditation process. Our SOPs, cleanroom practices, and quality systems are already built to PCAB standards — accreditation is the formal recognition of work we are doing every day.
USP 795 · 797 · 800 Compliance
Non-sterile compounds (795) · Sterile compounds (797) · Hazardous drug handling (800)
ISO Class Cleanrooms
Controlled environments with automated cleaning and environmental monitoring
LegitScript Certification
Pursuing recognized e-commerce compliance certification
Accreditation Roadmap
On the Path to PCAB & LegitScript
Our SOPs, cleanroom practices, and quality team are already built to those standards. Accreditation is the formal recognition of work we're already doing every day.
Contact Us About QualityThe People Behind the Quality
A Leadership Team Built for the Highest Standard
Our quality infrastructure wasn't designed by consultants — it was built by people who have spent careers setting the rules others follow. Every SOP, every protocol, every quality checkpoint at MediCraft traces back to this team.
Ex–Board of Pharmacy Inspector
Our Quality Partner spent years as an official Board of Pharmacy inspector — the same role responsible for auditing and enforcing compliance at pharmacies across the state. He now brings that regulatory perspective inside our walls, helping us build SOPs that don't just meet inspection standards — they reflect how inspectors think.
SOP Architecture · Regulatory Preparedness · Compliance Auditing
Director of Quality & Compliance Officer
Our Director of Quality oversees every standard operating procedure from cleanroom entry protocols to batch release criteria. As our internal Compliance Officer, they ensure every process — from raw material receiving to patient shipment — is documented, defensible, and consistently executed to the letter.
SOP Management · Batch Oversight · Regulatory Compliance
Formulation Expert
Formulation is a science, not a template. Our in-house Formulation Expert brings deep pharmaceutical chemistry expertise to every compound we develop — evaluating excipient compatibility, delivery mechanism optimization, stability data, and beyond-use dating with the rigor of a research laboratory.
Formula Development · Stability Analysis · Excipient Science
Senior Production Engineer — Big Pharma Background
Most compounding pharmacies have never had a production engineer on their team. MediCraft does. Our Senior Production Engineer comes from one of the largest pharmaceutical manufacturing companies in the world — bringing large-scale GMP production experience, process automation expertise, and a manufacturing mindset that most pharmacies our size simply don't have access to. They are responsible for engineering the production workflows, equipment validation, and process controls that ensure every batch is produced consistently, efficiently, and to the highest possible standard.
GMP Production · Process Automation · Equipment Validation · Manufacturing Quality · Batch Process Engineering
Lead Pharmacist & Formulation Expert — Quality Engineering Background
At the clinical and scientific core of MediCraft is a licensed pharmacist who is also a trained formulation expert with deep roots in quality engineering and pharmaceutical production. This isn't a background built in a single setting — it spans 503A compounding, 503B outsourcing, and cGMP manufacturing environments, giving MediCraft's formulation and quality leadership a perspective that most compounding pharmacies can't replicate. Every compound we produce, every SOP we follow, and every quality decision we make reflects that multi-disciplinary foundation.
Licensed Pharmacist · Formulation Science · Quality Engineering · 503A · 503B · cGMP · Production Background
Chief Technology Officer & API Integration Specialist
Technology should remove friction, not create it. Our CTO is also a seasoned API specialist with the capability to integrate MediCraft's systems with virtually any practice management software, pharmacy platform, or EMR/EHR system on the market. Whether your practice runs on Epic, Athenahealth, DrChrono, or a custom system — our CTO can build the connection and make the data flow seamlessly. From provider onboarding to real-time prescription tracking to automated refill workflows, every touchpoint is engineered to work within the tools your team already uses.
EMR/EHR Integration · API Development · Provider Onboarding · Order Workflow · Software Interoperability
SOPs & Accreditation
Written by Regulators. Executed by Pharmacists.
Standard Operating Procedures at MediCraft were not purchased from a template library. They were written from the ground up by a team that includes a former Board of Pharmacy inspector — someone who has personally evaluated SOP systems at dozens of pharmacies across the state.
Every SOP reflects not just what the rules require, but what an inspector looks for, what failure modes look like, and how to build systems that hold up under the most rigorous scrutiny. We are currently working through the formal PCAB accreditation submission process. MediCraft has not yet received PCAB accreditation — but our SOP library, quality team, and cleanroom practices are already written and operating to that standard. Accreditation is the formal recognition of a quality system we are already running.
- Full SOP library spanning compounding, cleaning, QA, and dispensing
- Written with active input from ex–Board of Pharmacy inspector
- Reviewed and updated quarterly by our Compliance Officer
- PCAB-aligned protocols ahead of formal accreditation submission
- Every staff member trained and documented on applicable SOPs
Facility & Automation
Automated Where It Matters Most
Human attention is essential in compounding — but so is eliminating human error from repeatable mechanical tasks. MediCraft has invested in facility automation that protects product integrity, ensures consistency across every batch, and documents every order on camera before it leaves the building.
Automated Cleanroom Cleaning Systems
Our cleanrooms are equipped with automated surface cleaning equipment that executes validated cleaning cycles with consistent chemical coverage and contact times — eliminating variability in one of the most compliance-critical tasks in sterile compounding. Every cycle is logged, timestamped, and available for audit.
Automated Vial Crimping Machines
Every injectable vial produced at MediCraft is sealed with a validated automated crimping machine — not by hand. This ensures consistent, uniform crimp quality across every vial in every batch, eliminating the risk of improper seals that can compromise sterility and product integrity.
Environmental Monitoring Technology
Our ISO-classified cleanrooms are continuously monitored with automated environmental control systems tracking air particulate counts, temperature, humidity, and pressure differentials in real time — with alarm thresholds that trigger immediate review before any product is affected.
Video-Verified Fulfillment
Every order is filmed during pick, pack, and seal — before the package ever leaves our premises. The footage is matched to the prescription number and archived alongside the shipping record, so what went into the box is documented, not assumed.
Chain of Custody
Every Package Filmed. Every Shipment Tracked.
What Gets Recorded
On every order
Pick & Verify
The finished product is pulled against the prescription on camera, with lot and beyond-use date visible in frame.
Pack & Protect
Contents, quantity, ancillary supplies, and cold-chain packaging are filmed as they go into the box.
Seal & Label
The carton is sealed and the shipping label applied on camera, tying the recording to a specific tracking number.
Hand-Off & Track
Carrier pickup is logged and tracking goes live — visible to the provider in the portal from that moment forward.
Why It Matters
- Resolves "wrong item" and "missing item" claims with recorded evidence, not recollection
- Distinguishes fulfillment errors from carrier damage and loss in transit
- Confirms cold-chain packaging was applied correctly before dispatch
- Supports investigation of any adverse event or product complaint after the fact
- Strengthens recall readiness — every shipped unit ties back to a lot and a recording
- Footage available to prescribers on request for any order we fulfilled
API & Raw Material Sourcing
We Don't Just Buy Ingredients — We Vet Them
The quality of a compound begins long before it enters our cleanroom. Our raw material qualification process is one of the most rigorous in the compounding industry — because we know that what goes in determines what comes out.
Supplier Qualification
Every API and raw material supplier must pass our internal vendor qualification process before a single ingredient is purchased — including review of FDA registration, quality agreements, and facility audit status.
Certificate of Analysis Review
Every incoming lot is accompanied by a full Certificate of Analysis from the manufacturer, reviewed by our pharmacist and quality team against established specifications before acceptance.
Identity Testing on Receipt
We do not accept vendor documentation at face value. Every raw material is identity-tested upon receipt using validated analytical methods to confirm it is exactly what it claims to be.
Potency & Purity Verification
Beyond identity, we verify potency and purity through independent, FDA-registered third-party laboratory testing before any ingredient is cleared for use in patient compounds.
Before it enters the cleanroom
FDA-Registered Sources Only
MediCraft sources all Active Pharmaceutical Ingredients (APIs) and excipients exclusively from FDA-registered manufacturers and distributors. We do not accept raw materials from unverified or overseas sources without validated documentation and independent testing.
Our Formulation Expert evaluates each supplier on an ongoing basis — reviewing stability data, manufacturing history, and any FDA warning letters or recalls. When a supplier's quality record raises a question, we find a better one before it ever becomes a patient safety issue.
- FDA-registered suppliers only — no exceptions
- Ongoing supplier performance monitoring
- Immediate supplier review triggered by any FDA action
- Quarantine and rejection protocol for non-conforming lots
Finished Product Testing
Every Batch Tested. Every Time. No Exceptions.
Potency Testing
Every batch verified at labeled concentration by third-party registered lab
Sterility Testing
USP ⟨71⟩ sterility testing on all sterile compounded preparations
Endotoxin Testing
Bacterial endotoxin (LAL) testing for all injectable formulations
Container Integrity & Appearance
100% visual inspection — particulates, color, clarity, crimp quality
Third-Party Lab Verification
Our finished products are tested exclusively by independent, FDA-registered analytical laboratories — no conflicts of interest. Every potency, sterility, and endotoxin result is produced by a third party with no stake in the outcome. Test reports are available to providers upon request.
Full Batch Record Traceability
Every compound is linked to a complete batch record — from the raw material lot numbers used to the final test results and dispensing record. Fully traceable, fully documented, and ready for any audit.
No Shipment Without Release
Nothing leaves MediCraft without pharmacist review of the complete batch record and passing test results. Product that doesn't meet specification is rejected and destroyed — not released, not repriced, not shipped.
The full path, receipt to release
Inbound — raw material
- 01
Supplier
FDA-registered, qualified
- 02
COA review
Against specification
- 03
Identity test
On receipt, validated method
- 04
Potency & purity
Third-party lab
Released to cleanroom
Outbound — finished product
- 01
Compounded
ISO 5 primary control
- 02
Sterility
USP <71>
- 03
Endotoxin
LAL, injectables
- 04
Pharmacist release
Full batch record
Shipped to patient
Technology-Enabled Quality
From Rx Received to Package Shipped — Seamlessly Tracked
The Technology Layer
A Seamless Process, Built by Our Own CTO
Most pharmacies stitch together off-the-shelf software and hope it works. MediCraft has an in-house CTO who is also a skilled API specialist — someone who doesn't just manage technology, but builds the integrations that make your practice's workflow truly seamless.
Whatever software your practice runs — Epic, Athenahealth, DrChrono, Kareo, Jane, a custom EHR, or anything else — our CTO can build the API connection to integrate MediCraft directly into your existing systems. No double entry, no manual status checks, no friction.
- EMR/EHR integration with any major or custom platform
- API-level connectivity — not just portal logins
- E-prescribing with real-time order tracking in your system
- Automated refill and status notifications pushed to your workflow
- Secure, HIPAA-compliant data handling at every integration point
- Custom reporting and analytics available for high-volume practices
Ready to Partner with MediCraft?
Join the providers who trust MediCraft to craft the precision compounds their patients need.