About Us
cGMP Compounding
Facts About the Current Good Manufacturing Practices (cGMPs)

FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (cGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives.


What are cGMPs?

cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors.

Outsourcing Facility
Outsourcing Facilities

The Drug Quality and Security Act, signed into law on November 27, 2013, creates a new section 503B in the FDCA. Under section 503B, a compounder can become an “outsourcing facility.”

The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.

Drugs compounded by an outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not from current good manufacturing practice (CGMP) requirements.

Outsourcing facilities:

• Must comply with cGMP requirements;

• Will be inspected by FDA according to a risk-based schedule; and

• Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.



What We Do

In November 2013, the Drug Quality and Security Act was enacted into law and established the designation of registered Outsourcing Facilities. Outsourcing Facilities are subject to additional government oversight and must implement strict manufacturing standards. These standards, called Current Good Manufacturing Practices (cGMPs), are designed to ensure the quality and safety of compounded medications.

The compounding that is performed in an outsourcing facility does not require an individual prescription. These facilities are able to produce pharmaceutical products that are not commercially available which in turn can be sold to offices, clinics and hospitals. These services are invaluable in times of drug shortages and for products that are not commercially marketed.

Our 503B Outsourcing Facility complies with cGMP standards including:

Full sterile gowning compliant with cGMP regulations.

Environmental monitoring of air, cleanroom surfaces and personnel.

Processes designed to ensure that every formulation conforms to high standards for identity, strength, quality, and purity.

Each batch of sterile product is tested prior to release: USP <71> compliant sterility testing and USP <85> compliant endotoxin

Cleaning, Sterilization and Process Validation protocols.

Stability programs

Products and Services
··· AND MORE ···

 

We can help you through nation-wide drug
stortages. We can supply combinations,
strengths and dosage forms not
commercially available.

 

Contact
Initial Consultation is free, with no obligation
keyboard_arrow_up