
Quality Assurance
This pharmacy is classified as an FDA 503(a) pharmacy and is licensed by the California State Board of Pharmacy. This facility is tested by an accredited laboratory service agency whose responsibility is to validate Mariner's Facility to meet the specifications of ISO 5, ISO 7 & ISO 8 of the United States Pharmacopeia's (USP).
This pharmacy is classified as an FDA 503(a) pharmacy and is licensed by the California State Board of Pharmacy. This facility is tested by an accredited laboratory service agency whose responsibility is to validate Mariner's Facility to meet the specifications of ISO 5, ISO 7 & ISO 8 of the United States Pharmacopeia's (USP).
- Electronic balances are certified annually by an ISO- 17025 Accredited Metrology Laboratory.
- ISO-8 anteroom certified every six month with viable & non-viable particle counts
- ISO-7 buffer room certified every six month with viable & non-viable particle counts
- ISO-5 Laminar Flow Hood certified every six month with viable & non-viable particle counts
- Continuous environmental monitoring and alert system employed
- Surface sampling monthly to ensure absence of growth
- Sterility/Endotoxin/Potency & Method of Suitability available for selected formulas
- Media Fill for Low, Med, High Risk for all Compounders every 6 month
- Infusion Specialty Department is Accredited by Accreditation Commission for Health Care (ACHC)
- Compounding Labs (both Sterile & Non-sterile Compounding) are independently accredited by Pharmacy Compounding Accreditation Board (PCAB)
Personnel & Process Validation
Pharmacists and Pharmacy Technicians who manipulate sterile IV admixtures must have impeccable aseptic techniques. They are trained by third party agency and must pass the Personal Aseptic Technique Test and semi-annual competency in order to participate in compounding activities.