Even as the European Medicines Agency (EMA) has released Annexe 11 –Computerized Systems guidelines, the Indian pharma industry and the regulatory authorities are also keen to have similar norms to prove efficiency in global markets.

The Annexe 11 –Computerized Systems guidelines is a supplement to its GMP Guide Chapter 4 on documentation to account for the increased use and complexity of computerized systems in the drug-manufacturing segment. The annexe relates to all kinds of computerized systems that are used as part of GMP-regulated activities. The updated Annexe will take effect from June 30, 2011.

Now the Indian pharma industry is also keen to have similar norms to prove efficiency in global markets.  Commenting on the it, Indian pharma industry and regulatory officials stated that they are also looking for a similar guidelines which would help to prove the competence and reliability of drug manufacturers in the global market.

India has over 150 USFDA approved facilities which is highest outside the US and an increasing number of EMA approved production units. US is following the GAMP-V (Good Automated Manufacturing Practices.) guidelines. The US regulatory major has commenced joint inspections with EMA beginning with European Union. Very soon a similar initiative is likely to be followed in other countries. Since India is a key hub for contract manufacture and production for the regulated regions of US and EU, it will need to view the implementation of computerized systems guidelines sooner, stated Kaushik Desai, chairman, Industrial Pharmacy Division, Indian Pharmaceutical Association (IPA).

“But the reality is that Indian expertise is limited in computerized systems from a drug regulator and industry perspective. Currently, this component is outsourced by majority of companies. Sooner or later, the computerization norms will need to implemented by the Indian drug regulatory authority, he added.

Another fact is that government of India has identified information technology and the pharma sector as knowledge industries. But there is a huge challenge for the pharma sector to attract the expertise going by the lucrative prospects of professional growth in the IT industry. Therefore, Indian pharma industry requires intensive and broad based training in IT skills not just at among industry personnel but more critical at the inspectorate grade in the drug control offices across the country, averred the IPA Industrial Pharmacy Division chairman.

The Annexe which is featured in the Electronic Newsletter of Pharmaceutical Technology (ENPT) was circulated by Industrial Pharmacy Division of IPA as part of its Knowledge Initiative Programme.

Key aspects highlighted by EMA with regards to the new Annexe include validation of the computer applications. While moving from manual operation to computerized operation, EMA has cautioned the industry to   ensure that product quality and process control factors are not reduced.  Further, it also addresses risk management as a tool that should be applied throughout the life cycle of the computerized system, taking into account factors such as patient safety and data integrity, besides delving into agreements and working relationships among personnel and third parties. Finally, the revised Annex reviews project and operational phases of drug manufacturing and how computerized systems can play a role in these stages of documenting validation, checking for accuracy, and maintaining audit trials, according to ENPT.