Nothing good comes out of chaos and in an industry where minute errors can wreak havoc, following regulations and maintaining standards is a must. The quality and efficacy of pharmaceutical products is directly proportional to quality assurance and control. Hence, a reliable approach to maintaining these standards is indispensable for the larger good. The reason behind this strict control is the health of masses.

Reliance on the manufacturer

None of the both, a pharmacy or medical professional, can tell the difference between a quality product and an otherwise inferior one by just looking. Owing to this reality, the sole responsibility lies on the manufacturing department – In this case, the pharmaceutical industry. There are multiple factors during the whole process that can affect the production and quality of the drug, therefore implementation of strict protocol and regulations is important.

How do best practices help?

There are best practices for each process and emphasizing on these practices helps achieve the goal in a smooth manner. In pharmaceutical industry, these can be called as drug trails, discovery, distribution, manufacture, and storage – particularly not in this sequence. All of these encompass pertinent good practices for laboratory, clinics, manufacturing, distribution, and storage.

Guidelines by Region

Regulations and standards vary by country and region. This in reality only bolsters the importance of protocol for this industry. For the United States of America, these standards are kept in check by Food and Drug Administration (FDA) in the form of Current Good Manufacturing Practice Regulations. FDA inspects and issues guidance for manufacturers and distributors around the world. However, these guidelines don’t bind the manufacturers to follow them only and any alternative is acceptable as long as it fulfills the requirements and follows the regulations.

For European Union, the story is a bit different. For every member state, there is a competent authority that is in charge of authorizing and registering the importers and manufacturers. The compliance should be in accordance with the EU Good manufacturing Practices (GMPs). Now the assessment frequency largely depends on the risk assessment. However, if an importer is importing any drug then the responsibility lies solely on the importer to ensure compliance with GMP.

What exactly are GMPs?

Now what exactly are these GMPS or practices that we have been talking about? It’s a set of regulations which encircles everyone from the manufacturer to senior management to those in charge of any process involved. From making sure whether the process is safe, adequate, and complies with the assigned regulations to assuring hygiene and disinfection of materials and equipment involved, everything comes under Good Manufacturing Practices.

Martin Dow along with other pharmaceutical companies therefore takes all of these standards and regulations very seriously and aims to maintain the highest level of protocols assigned. This consideration is especially important because it affects the collective health of society. There is a set of regulations for personnel, personal hygiene, equipment, premises, waste disposal, and materials. These need to be followed in true spirit and letter because things can really go south, otherwise.