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Why Outsource Sterile Compounding?

SAFETY, COMPLIANCE and ADVANTAGES TO YOU

Hospital pharmacies everywhere grapple with the cost benefit analysis between insourcing and outsourcing sterile compounded products. At SCA Pharma, we believe that outsourcing provides greater value to you in these three primary areas:

Safety

You can minimize medication errors in your facility because of our custom standards and processes, including:

BARCODING
SPECIALIZED LABELING

Prior to release, we perform testing on all end products for:

STERILITY
ENDOTOXIN
POTENCY
IDENTITY
PASSING ENVIRONMENTAL AND PERSONNEL MONITORING

Compliance

SCA Pharma adheres to cGMP, which exceeds the quality and safety standards of USP <797>

SCA Pharma deploys a team of more than 90 dedicated quality professionals, ensuring that our procedures and products meet those strict standards.

Advantages To You

You can reduce labor costs associated with drug preparation.
Our stability studies can confirm extended beyond-use dates.
Eliminate drug waste with our single-dose and ready-to-use preparations.
Enjoy increased access to a greater variety of strengths, dosage and presentation.

The Insourcing vs. Outsourcing Story: cGMP vs. USP <797>

When it comes to compounding sterile products, 503B “Outsourcing Facilities” like SCA Pharma must comply with strict cGMP (good manufacturing practices) requirements and be subject to FDA inspections. Hospital pharmacies, for now, are still able to operate according to USP <797> guidance.

This is a critical issue when weighing the costs and benefits of insourcing or outsourcing.

The differences between the regulatory guidelines are staggering. Hospitals and pharmacists should carefully weigh these differences and consider which option best assures product quality and patient safety.

Requirement:

cGMP

USP <797>

Enforced unidirectional flow of personnel and materials

Defined areas for production with line clearances

Beyond-Use-Date (BUD)/Expiration date, stability and endotoxin testing required for ALL products

Required final container sterility/potency/stability testing and reserve samples for every batch

Material testing required

Quality Control quarantine and release testing required prior to release

Continuous temperature, pressure and humidity monitoring

Daily environmental monitoring of air, surface and personnel

Full sterile garbing required

(sterile gloves only)

Fully qualified sterile disinfectants and sporicidal agents

(isopropyl alcohol only)

Required equipment, process, IT system and cleaning validation

GDP documentation required for all batches, testing, processes and validation

Change Control Required

Required Adverse Drug Event (ADE) reporting with root cause analysis

Selecting the right solution for delivering Critical Medications to your patients is one of the most important decisions you must make.

Your practitioners and your patients are relying on you.

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