APP Pharmaceuticals (APP) strives to lade in the United States and Canada to be a leader for injectable pharmaceuticals. The company, philosophy is to provide excellent products and services by hiring dedicated and committed employees to meet our customers' needs. Our primary goal is to improve the health and care of patients who use our pharmaceutical products.
II. Background/Overview of APP Pharmaceuticals
APP was established in 1996 and has quickly become one of the industry leaders in providing one stop shopping for very commonly used products to very special products to meet the needs of a wide range of patients. There market produces 142 products in over 400 doses and formulations. A few of the clinical areas they cover are: Cardiac Care, Dialysis, Emergency, Intensive Care, OB/GYN, Operating Rooms, Oncology, Orthopedics, Pediatrics, Psychiatry and Radiology. (APP Pharmaceuticals, unkown)
APP is the number three generic injectable supplier in the United States, and the only U.S. generic company with a dedicated cephalosporin injectable plant. APP currently employees over 1800 employees in North America with manufacturing facilities in Melrose Park, Illinois, Grand Island, New York, Raleigh, North Carolina. The corporate headquarters, science production and technology center is located in Skokie, Illinois. (APP Pharmaceuticals, unkown)
As mentioned previously has 140 products and these products range can be classified into 3 families of pharmaceutical families which are Herapin, Diprivan and Naropin.
The focus on the quality management begins with the supplier. The supplier for Heparin uses an Active Pharmaceutical Ingredient (API) along with a very update to date purification technology and provides trustworthy traceability to materials. SP's supplier ensures USP testing is performed prior to shipping any product to us.
Once the product arrives at their manufacturing site another round of USP testing for quality and purity is again conducted. The product is filled into vials and a thorough inspection is completed before packaging and labeling is performed. Once the final product tests are completed the product is again inspected and tested to ensure USP standards are met.
III. Introduction to the Problem
APP has recently experienced quality issues that have resulted in compromised patient safety, poor customer service, citations from the Food and Drug Administration (FDA) and producing substandard products. Most specifically the challenge has been with the Heparin. The initial analysis performed as regards to the Heparin quality issues can be defined into two categories patient safety and contamination of the Heparin.
On February 29, 2012 the Food and Drug Administration (FDA) reported "under 'a fine mess.' the FDA has tagged SP Pharmaceuticals for so many systemic problems -insects; vials with missing labels; failed assays; contamination; floating particles and a failure to file reports or follow-up complaints - that the agency has instructed the executive team to "undertake a comprehensive and global assessment," according to a warning letter issued last week."
"The letter, in fact, reads like a how-to list - how to screw up, in this case. What is likely to generate wider notice, though, is a reference to problems a potential trend of failed assay results for different batches of both the active pharmaceutical ingredient and finished product. Now, the FDA wants APP to submit a three-year history of test results and subsequent internal investigations." (Pickett, 2012)