McGuff Compounding Pharmacy

Our home since early 1999. Our modern facility has undergone two major upgrades to meet the changing needs of our customers, State Board of Pharmacy and the FDA.

Our Management Team

Over 100 years of combined experience in Pharmacy, Compounding Pharmacy, ISO Quality Systems, Current Good Manufacturing Practices, Regulatory Affairs, and Customer Care.

Quality Systems Group

It is highly unusual for a compounding pharmacy to have a separate department devoted solely to quality systems. This group operates independently of our Pharmacists to review/inspect procedures, products, and perform audits to assure the highest standards are acheived.

ISO Certified by Independent Auditors

We are proud to be the very first compoundng pharmacy to achieve the
ISO 9001:2000 Quality Systems-Model for Quality Assurance in: Product Design, Product Development, Production, Installation and Servicing.

It All Starts Here

A telephone conversation with one of our pharmacists. All of our pharmacists are Doctors of Pharmacy and are available to help answer any questions that you may have.

We Compound Many Types of Medications

Even though we compound a wide variety of medications we do not compound everything. We have a fifteen-page qualification procedure that is used to evaluate each new medication. It is vitally important that we understand all the peculairities of each product before we decide to make it.

Encapsulation

Oral administration of compounded medications is by far the most common route of administration. Compounding is an art as well as a science. Our pharmacists rely their expertise, our quality system and our independent quality systems group to provide consistent, uniform and reliable medications.

Route of Administration

Troches, Capsules, Creams, Suppositories, Gels, Solutions and Suspensions. As compounding pharmacists we are able to change the route of administration of many commercially available medications. This is done to make them better tolerated or to improve adsorption.

Injections

Injections represent a very special and complex route of administration. In California, a pharmacy that compounds injections is required to have a special license and is inspected by specially trained pharmacy inspectors. Our pharmacists and technicians are proud of our sterile compounding facility and products.

Class 100, 10,000 and 100,000 Clean Rooms

Our compounding pharmacy is built around a core of class 100 filling stations. Each filling station is in a class 10,000 clean room which in turn is surrounded by class 100,000 clean rooms. This requires three different levels of gowning.

Independent Calibration

A pharmacist must rely on the equipment in the pharmacy. The equipment must be tested on a regular basis to assure accuracy or performance. The McGuff Compounding Pharmacy retains independent auditors that inspect all critical equipment. Complete documentation of equipment calibration is retained for inspection.

Magnehelic Gauges

Air pressure is critical to the maintenance of a sterile fill operation. Our class 100 sterile filling stations maintain a positive pressure greater than the class 10,000 clean rooms. The class 10,000 clean rooms maintain a positive pressure to the class 100,000 clean rooms. The Magnehelic gauges allow us to visually verify air pressure differentials.

Synergy of Compounding and Manufacturing

Our pharmacy is collocated within our FDA registered sterile fill manufacturing facility. Both companies work together to provide exceptional products to our customers. No other pharmacy that we are aware of has CFR Title 21 cGMP compliant water for injection loop, vial washing and vial depyrogenation. Water for injection is a critical component of any injectable medication.

Pharmacists and Pharmacy Technicians

Outstanding employees make an outstanding company. Training and validation are the cornerstones that make outstanding employees. McGuff Compounding Pharmacy maintains ongoing training and validation trials to assure all employees are current with accepted pharmacy practices.

Aseptic Filling of Injections

Micro HEPA air filters produce an ultra clean environment for the aseptic fill of injections and protect each sterile filling station. Each filling station and clean room is environmentally independent of the others to prevent cross contamination of products.

Specially Designed Pass Through Protection

Each clean room is designed to protect the product and to maximize efficiency. Our specially designed pass through allows only one side of the pass through to be open at any time. This assures product integrity and allows for the easy transition of product out of the sterile fill rooms.

The First of Many Inspections

After crimping, each vial produced is visually inspected for particulates against a black and then a white background. Each pharmacist and technician is not only trained on how to perform this operation but must pass a visual exam by a licensed Ophthalmologist. We are serious about quality.

Evacuated Chamber Test

A representative sample of each injection is placed into a vacuum chamber upside down to test for leaks. The seal of each vial is a critical component to assure sterility of the medication inside. Many competing pharmacies pierce the rubber stopper to fill the vial. We do not. Our products withstand this sort of testing.

Our ISO 9001:2000 and cGMP Approved Microbiology Lab

McGuff Compounding Pharmacy and it's sister company, McGuff Pharmaceuticals, Inc. maintain an independent laboratory to test our compounded medications prior to finished product release. Many tests are done in-house but not all. We are very proud of our microbiology lab and our independent quality systems people who run it.

Endotoxin Testing

Endotoxin is a complex bacterial toxin composed of protein, lipid, and polysaccharide, which are released only upon lysis of a cell. Endotoxins in injectable medications beyond a certain level may cause serious health problems, even death. There is no legal obligation for a compounding pharmacy to test each batch of injections for endotoxins. McGuff Compounding Pharmacy believes the safety of our patients comes first and therefore tests each batch of injections for endotoxins even though it is not required.

Sterility Testing of Injections

All injectable medications must be sterile when injected. However, compounding pharmacies are not required to test each injectable batch for sterility. To assure the continued health of McGuff pharmacy patients we test for sterility on each batch of injections produced. Additionally, we do not puncture the rubber stopper. This assures the patient that the contents of the vial remain sterile until used.

Sterility Testing of Injections, Continued

Many pharmacies do not test for sterility for two reasons. First, it costs extra money and second, it takes about two weeks. The McGuff microbiology lab uses the same U.S.P. procedures to test for sterility as manufacturers of injectable medications.

Finished Goods Cage

The McGuff Compounding Pharmacy anticipates prescriptions and produces products in a just-in-time environment that includes the two-week delay for sterility testing. When an injection passes endotoxin and sterility testing it is placed into our finished goods cage for protection. Refrigerated products are kept in a secure refrigerated area that is thermostatically controlled and temperature verified by chart recorder.

Product Safety and On-Time Delivery

The pharmacists fill your order and it is packed in our special boxes for protection. We deliver anywhere in the United States and its protectorates in two-days. Overnight is available. Please call or send us an e-mail if you have questions or comments. We are here to help!