Indian pharma industry needs to arm itself to be in perpetual audit mode. This is because of the new stringent global regulatory norms that are being enforced and the frequent inspections by the international regulatory enforcement teams, said Dr Vinay G Nayak, president, technical operations, Alembic Pharmaceuticals.

Since 2008, the US FDA issued 483s warning letters and imposed ban on production plants of Indian pharma companies following non adherence to quality standards and have put the sector under surveillance. The only way to gain confidence of the regulator, clear doubts and relax scrutiny would be to put in place systems to document practices, prevent microbial contamination of drugs, bring in reliability and integrity in procedures across laboratory and manufacturing systems, he added.

The way forward for a confident regulatory compliance would be to automate process of manufacturing, computerise lab operations, install surveillance systems across the facility to bring in transparency and accountability at all levels. There should be review of standard operating procedures versus practice, said Dr Nayak in his presentation on ‘Quality audit case studies- major quality issues and trends’, presented at the recently concluded IPA Platinum jubilee event.

There are parameters for inspection by the global regulators. For instance, while the US FDA focuses on documentation EMA and MHRA focus on shop floor and lab activities, Mexico auditors check written procedures with reference to the actual practice. “A successful inspection is important to benefit the patient who is prescribed with the drug. Therefore there is need to avoid regulatory action and ensure the company’s reputation is intact,” he noted.

Global regulators in their inspections of Indian production plants carried out between 2011 to 2013, have found glaring discrepancies. The observations include use non-sterile gloves, visible holes and flakes on the gloves, improper storage of gloves, insect on outer packaging and use of the same cleaning accessories in all areas of the facility. There have also been instances of torn data sheets in the waste bins, diverting FDA inspectors attention by pharma officials from the auditing area and providing misguided information by the production plant heads.

Besides, there have also been contamination in active pharmaceutical ingredients (APIs), investigation restricted only to retained sample, absence of supporting data to justify corrective and preventive action (CAPA), dissolution failure attributed to high alkaline pH in tablets, but the tablets which failed dissolution test were found not to not to be tested for pH.

In this digital age where electronic records formats take centre stage, the global regulatory agencies persuade need for automation and up-gradation of technologies. “There is need to adopt electronic data management to ensure consistency in process to sustain quality across the pharma company. Therefore, Indian pharma should adopt real-time process controls, electronic batch records to reduce manual errors and improve efficiency and productivity. This would be only way for the companies in the country to be in perpetual audit mode, said Dr Nayak.