Partner Article

Pharmaceutical Compliance – Safety and Quality

Pharmaceutical industry is one where the stakes are high, but a small error during development and manufacturing stage may cause huge losses to the company. An estimated 20% of the expenditure is spent for research and development. Every year pharmaceutical companies are also spending a lot of money for fighting cases of violation of regulations, in the form of fines and auditing charges. Also there are losses due to recall of products for non-conformation of norms. To minimize such expenses a modern day, pharmaceutical industry should have an efficient pharmaceutical compliance team.

Safety and quality are the two main pillars on which the pharmaceutical regulations are framed. Even though the regulatory authority is different in different countries like ICH in Europe, Japan and US, FDA of US, MHRA of UK, EMA of Europe, Health Canada, CDSCO of India etc., common guide lines including that of WHO(medicine) are accepted by all.

A company’s compliance program should include elements such as a team of experienced managers and trained staff, policies and regulations, internal monitoring and auditing, rapid response and corrective actions, imparting training and a good communication system. In many countries there are firms which impart pharmaceutical training. Courses are available in product development, manufacturing support, R&D support, and in-house training. These help professionals to update their knowledge of latest regulations and standards in pharmaceutical industry. In every pharmaceutical industry members of the compliance team should be asked to attend such courses as continuation of professional development.

As a part of making the pharmaceutical industry more error proof, authorities and private firms are regularly conducting pharmaceutical training seminars in various countries, like CBI net of US and London based Pharma compliance. In these conferences, discussions are carried out regarding the challenges faced by the pharmaceutical industry. Companies should send their pharmaceutical regulatory compliance team members so that they will be aware of the latest trends in the industry.

Pharmacy training is also an important aspect in the subject of pharmaceutical compliance. Pharma webinar uses latest web conferencing techniques where one can get access to seminars conducted by experts in pharmaceutical industry. WTG pharma and Fleming Europe host pharmaceutical webinars live on demand where one can log in and listen. In addition WHO, UNICEF and UNFPA are conducting pharmaceutical training seminars in various countries.

Pharmaceutical regulatory requirements vary from country to country. The manufacturing and marketing of pharmaceuticals has become a complex affair due to the various laws and regulations concerning market authorization, clinical trials, orphan drug protection, patent rights among others. These regulatory requirements are needed to protect health and safety of the population. As per a study by WHO 74% of the countries have medical laws to control production, market access, promotion and pricing of pharmaceutical products.

This was posted in Bdaily's Members' News section by Marcia Carlan .