Our Standards
Quality & Manufacturing
01 · The cGMP Pathway
What Is a cGMP Facility?
FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (cGMP) regulations. The cGMP regulations for drugs establish minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. These strict standards are designed to minimize risks to patient safety by ensuring that each medication consistently meets its intended identity, quality, purity, and labeled strength.
The approval process for new and generic drug marketing applications includes a review of the manufacturer’s compliance with cGMP. The FDA assessors and investigators determine whether the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to market.
Why the Manufacturing Pathway Matters
- Application of current Good Manufacturing Practice (cGMP) requirements
- Routine risk-based FDA inspection of the cGMP facility
- Requirements for product and adverse-event reporting
- Production and quality systems designed for sterile compounding
- Ability to supply high quality, ready to administer medications with longer BUDs than drugs compounded only to USP standards
02 · OurPharma Overview
Manufactured by OurPharma
OurPharma is an FDA-registered cGMP facility located in Fayetteville, Arkansas. It serves hospitals, health systems, surgery centers, medical and dental groups with ready to administer compounded pharmaceuticals for clinical use.
OurPharma’s quality system includes vendor qualification & audits, incoming material review, controlled aseptic processing, continuous environmental monitoring, finished-product visual inspection, third-party laboratory testing and quality review before batch release.
OurPharma Quality Systems
- Regulated by the FDA, DEA & State Boards of Pharmacy
- Drug Distributor Accredited by the NABP
- A 24,000-square-foot cGMP facility with dedicated cleanroom space
- 24/7 Environmental monitoring of temperature, humidity, non-viable particulate and differential air pressures with Lighthouse constant monitoring system
- Vendor qualification and controls over incoming materials
- Aseptic processing in an ISO 5 environment
- Visual inspection of 100% of finished units
- Testing for all product batches that includes identity, potency, sterility, endotoxin, sub-visible particulates, pH and appearance
- Independent Quality review of testing, monitoring and batch records before release
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