Goa Pharmaceutical Manufacturers' Association (GPMA) will be collaborating with Medicines and Healthcare products Regulatory Agency (MHRA) to conduct a one day seminar on inspection and regulatory practices. Through this event the GPMA wants to sensitise the pharma exporters about what to expect during an MHRA inspection.
This event will be held at Hotel Goa Marriott, Panaji on October 15 and will be addressed by Good Manufacturing Practices (GMP) senior inspectors Michael Woodhall and John Clarke from MHRA UK.
This will be the first time that GPMA will be working along with MHRA for the benefit of the pharmaceutical industry. Arun Naik, president, Goa Pharmaceutical Manufacturers Association (GPMA), informed that this event is being organised with a view to inform and train the Indian manufacturer's on the requirements that a company has to go through for the MHRA certification.
“The European market is very lucrative for the Indian manufacturer's but they have very strict rules that are needed to be adhered by the Indian companies if they want to do business there. What we aim to do is provide a platform to the pharma companies to clear their doubts directly with the MHRA officials so that they can assist us with detailed guidance on the certification process,” Naik said.
As of now, nearly 20 units from Goa have MHRA approval and are engaged in doing business with the European countries. He added, “Europe has a huge market potential for the Indian pharma manufacturers which is prompting many to get MHRA certification. Moreover, the process for getting this certification is very difficult and once it is obtained there are tremendous advantages for the companies that helps in boosting their business.”
MHRA certification lasts for two to three years depending upon the period for which it is being certified by the officials.
Naik stressed that this is a rare occasion where MHRA directly involves itself with technical people from pharma manufacturers in India. He urged all the pharma companies vying to get MHRA certification which is a must for exports to most of Europe, to be part of it.
This event is expected to benefit individuals from different operating areas such as manufacturing, quality control, quality assurance, analytical development, regulatory affairs, validation teams and personnel responsible for GMP compliance and performance etc.