Process Validation Protocol and Report

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

It is usually presented in the form of a report in tables, charts, statistics, and graphs or on spread sheets etc. This data may be used to arrive at important decisions within the organisation or with external organisations. So the data report has to be produced in such a way that it meets the aims and

1.1 Describe the purpose and benefits of organising data so that it can be analysed

Always make sure that the data you collect serves the purpose of the report you are going to prepare

Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and

research. (Grounder, 2013) Today pharmaceutical companies are held to a very high safety standard when it comes to marketing

The main center within the FDA for the evaluation of medication is known as the Center for Drug Evaluation and Research. The center evaluates all drugs before they are sold. It currently evaluates more than 10,000 drugs that are on the market to ensure that highest standards of those drugs. They also monitor media broadcasts to make sure that messages portrayed are truthful to consumers. Lastly, they provide health care professionals as well as consumer’s information pertaining safest and most effective ways to use drugs. There are three phases that the CDER uses when evaluating drug.

Physicians must prove that there is no other comparable or satisfactory alternative in order to diagnose, monitor, or treat their patient’s condition or disease. They must also conclude that the potential risk of the product is not greater than the risk of the disease or condition (Expanded Access 1). The FDA must also determine that here have been enough tests done already to provide sufficient evidence as to the safety and effectiveness of the product and its use in the case (Expanded Access 1). In addition, the FDA must also be certain that by providing this product to patients outside of the clinical trial it will not interfere with the clinical trial, and the FDA acceptance of the drug (Expanded Access 1). Another requirement is that the company developing the pharmaceutical product, or the clinical investigator, submits a treatment plan (clinical protocol) for the patient, which must follow the FDA’s regulations for INDs (Investigational New Drug) or IDEs (Investigational Device Exemption Application), which describe the use of the investigational product (Expanded Access 1). Pharmaceutical companies must also submit a draft of the Data Development Plan (Expedited Access Pathway Program).

To better understand the issues associated with the prescription drug industry, it would first be best to understand their development and approval process. For a new drug to enter the market, it must first undergo a lengthy and often expensive research and development. Once a company submits an application for a new drug, it is their responsibility to provide the evidence showing its safety and effectiveness. Until they have undergone these criteria of guidelines and standards set in place, they will not receive FDA approval.

Before any biopharmaceutical company can begin to manufacture a desired product, the company is required by law to establish an adequate facility to support a safe and efficient manufacturing process. The US Food and Drug Administration (FDA) department under the authority of the Federal Food, Drug, and Cosmetic Act determines whether or not a specific manufacturing facility is approved. Furthermore, companies must adhere to the Good Manufacturing Practice Regulations (GMP) specifically those described in ICH Q7 in order to effectively fulfill FDA requirements. The fundamental purpose of the regulations beforehand is to accomplish a system that ensures products are consistently produced and controlled to the highest standards and thus prevent human safety risks that may not be reduced through testing the final

In-process inspection and test to determine the status of the process (rather than for product acceptance). .

A contract manufacturing company has been analysing a tablet product by the method described in the British Pharmacopoeia (BP) monograph. This is the method detailed on the product License and BP methods are generally considered to be validated. After trend analysis for the annual Product Quality Review (PQR) report, it has been discovered that 5 batches were rejected in 2013 due to high out of specification assay results. Furthermore, several batches had assay values close to the upper specification limit. The release specification limits for the product are 95-105%.

This is the phase where the requirements are noted, feedback regarding requirements are obtained from users