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Global Standards of Quality Assurance in Clinical Trials

Quality assurance guarantees GCP standards. GCP stands for good clinical practice. It is only through various quality assurances, the trust of customer is gained. The entire protocol includes checklists, standard inspections, project audit and documentation.

Following is the list of quality assurance in clinical trials.

1. ISO

ISO stands for International Standards Organization. It is the ultimate authorization of standards which is accepted globally for industries. ISO was formed in 1947. There are various kind of ISO standards used according to specifications. For example, ISO 11239 is used for pharmaceutical dose forms and packaging, ISO 11615 is used for product information of regulated medicines and ISO 11616 is used for the information of regulated pharmaceutical product.

When it comes to clinical trials and their quality assurance ISO 14155:2011 standard is used. This certification is given to newly-approved experimental drug after successfully clearing the ISO test protocol.

2. FDA

FDA stands for Food and Drug Administration is a federal agency of the United States Department of Health and Human Services. It was formed in 1906.It is one of the chief administrative teams that supervise the pharmaceutical products, dietary supplements, medicines and drugs for human consumption.  They administer the clinical trial sand research that supply new drugs to pharmacy and medical counters.

Although, the medicine goes through series of tests during the clinical trials and it is safe for human consumption, FDA secures the safety and effectiveness of the drug.

3. ICH

ICH stands for The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. The authorities here encourages public health through productive product registration and development by supervising the technical and scientific outlook of the entire process.

ICH promotes safety and efficacy of the clinical trials. Sometimes, there are chances of chemical agents of the drug hampering with the genetic information in the cell. It can be hazardous as it is cancerous. This is called genotoxicity.  Chemical agents when interfering with the reproductive system of the body it is known as reprotoxicity. ICH safeguards the public health from such hazards by putting forth safety guidelines for the clinical trials and research.

Their main agenda is the development of only high-quality medicines and medical procedures.

4. WHO

World Health Organization or WHO promotes research transparency when it comes to clinical trials.It was established in 1948. The ethical and integral guidelines are established with respect to clinical trials being safely and effectively conducted on humans.

The scientific and structural base of clinical research thus strengthens with the implementation of GCP guidelines put forth by World Health Organization. The rules in the guidelines differ from country to country.

It strictly promotes ethical, moral, scientific, safe and transparent clinical trials.

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