Free Essay About Pharmaceutical Manufacturing

Type of paper: Essay

Topic: Drugs, Manufacture, Manufacturer, Quality, Patient, Nursing, Law, Regulator

Pages: 2

Words: 550

Published: 2020/10/23

On November 7 of 2007, the Public Health Service Food and Drug Administration issued a warning letter to Amerifit Brands, Inc. (this is a manufacturing drug company on the 11 State Street, Woburn, Massachusetts). The Food and Drug Administration (FDA) conducted investigations of the facility as from April 10 to May 10, 2007. When the investigation were concluded, the investigators of the regulator found that the manufacturer had violated some section of the FDA's current good manufacturing practice (CGMP) rules on the 21 title which are commonly referred as Code of Federal regulation specifically sections 210 and 211. These violations caused adulterations to the drugs which made the drugs poor in quality or dangerous to the human health.
The regulator found the procedures and method used in the manufacturing, processing, and storage of the drugs don’t conform or comply with the regulation set forth by the CGMP. These regulations make sure that the manufacturer of drugs meets the safety standards and they are safe for human consumption. Additionally, the manufacturer must demonstrate that purity and the quality of the drugs are not compromised in any way.
After the inspections the officers of the Food and Drug Administration (FDA) found that the manufacture failed to confirm whether each batch released to the market conform to the final descriptions of the drugs. The officers found that the manufacture did not test the drugs before they were released to the market. Thus, the manufacture was not sure whether the drugs match the description of the strength and the identity of the active ingredients which are acclaim to be on the drug specifications details. The regulator requires the manufacturer to conduct scientific test on the drugs to confirm the specification on the ingredient’s strength, quality and purification. Additionally, the manufacture failed to assess the reliability of the suppliers of the drugs to the market. According to the regulator rules the manufacturer is required to conduct regular tests to check whether the suppliers are reliable and the quality or safety of the drugs are not compromised or violated. Moreover, the investigator found that the manufacturer used component such as containers which have been rejected since they did not meet the specifications on the quality and purity strength specified in the code of federal regulations
The inspectors found that the manufacture did not inspect the raw materials of the drugs if they have meets the quality, strength and purity as specified in the law. Additionally, the manufacturer did not check or test whether the ingredients in the in-process materials are still active and they meet the safety standards. Various samples collected in various sections of the production were not tested to identify their purity, quality and strength. The manufacturer also did not have a credible data which will specify the expiration date of the drugs. Furthermore, the manufacturer did not have a good control system which will prevent mix-up of the drugs or the raw materials during the manufacturing process. The stores where the drugs were stored were not monitored to check whether the temperature and the humidity were appropriate for storing the drugs and the identity of the drugs were not altered by inappropriate temperature and humidity.
The manufacturer did not have records to show the expiry date of the raw materials in the stores. The manufacture also failed to conduct an annual quality test of its drugs to check whether there was a need to change the process of manufacturing or the ingredients of the drugs. Lastly the manufacturer did not update the information of the drugs with the regulator in the past two years to show any changes or any challenges met in the course of production.
These are serious violation on the part of the manufacturer since the safety of the drugs is compromised. The drugs are dangerous to the public since they can be contaminated with impurities. Thus, instead of curing the disease the patient is suffering from, the drug introduces another illness or poison the patient. This can have devastating effect on the life of the patient since the patient can die or developed complications which are incurable. It is very important to know the expiry date of the drugs. The drug which has expired might not be able to cure the patient since it has lost its strength. On the other hand, an expired drug can be poisonous hence kills the patient.

Works Cited

FAD. "Amerifit Brands, Inc 07-Nov-07." U S Food and Drug Administration Home Page. N.p., 2009. Web. 27 Jan. 2015. <>.

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