At a time when the international regulatory bodies are trying to crack the whip on Indian pharma manufacturers for various reasons including aseptic techniques and practices adopted in the production of drugs, injectables and vaccines,  the Parenteral Drug Association (PDA) India chapter has deliberated on the processes and procedures to be adopted to reduce the microbial contamination in all the spheres of drug production.

The association has organised a one day workshop on ‘Aseptic Techniques & Practices’ in Indore, last week with a view to educate the pharma manufacturers in the country on the necessity of creating an environment, free of harmful micro-organisms, in various phases of drug production.

The programmeme was inaugurated by Dr S B Rijhwani, vice president & chairman, Industrial Pharmacy Division of Indian Pharmaceutical Association (IPA), who, in his inaugural address emphasised on the importance of compliance of aseptic techniques and practices in pharmaceutical manufacturing.

He said due to the sensitivity and high risks associated with the aseptic manufacturing process, it attracts high level of regulatory scrutiny from regulatory agencies across the globe. The aseptic technique is used to minimise contamination by micro-organisms. The microbial contamination causes infection in the patient and it may even lead to death. The technique has gone through several technological innovations from time to time and those engaged in pharma manufacturing should update the techniques and practices.

“A single particle, viable or nonviable, within an injectable drug vial is capable enough to cause various adverse drug reactions, potential health hazards and to trigger a ‘field alert’ or recall, in both regulated and non-regulated markets. The Indian pharma industry is passing through a bad phase where the drug manufacturers are criticised or attacked by the regulators like US FDA and MHRA for various reasons, including aseptic techniques and practices”, Dr Rijhwani opined.

The workshop saw top experts from pharmaceutical industry discussing the challenges and available solutions for aseptic techniques, the do’s and don’ts during qualification/validation of the process, aseptic practices of microbiology laboratory, risk assessment and investigation for sources of contamination in critical areas. The programme witnessed an overwhelming response from pharmaceutical industry across the country and it brought together around 150 technical staff and experts to ponder over the idea.

The PDA India chapter was represented by Sanjay Singh, president of the association, Vishal Sharma, secretary and Ivy Louis, treasurer. Vikram Shukla, member, events committee, Ranjit Menon, Nandkumar Kagvate and Shirish G Belapure, members, communications committee, and others attended.

Thomas Ludke, vice president,  operations, Hospira India shared some of his past experiences with both MHRA and USFDA. Sanjay Singh, senior vice president, Aurobindo Pharma Ltd spoke on the Do’s and Don’ts during qualification/validation of aseptic technique.

The participants and speakers discussed the current challenges faced by Indian pharmaceutical manufacturing industry (parenteral manufacturers) which is facing enhanced global regulatory scrutiny.  The organizers felt that frequent interactions on aseptic processing were needed among the pharma industry leaders and the workshop decided to conduct seminars on the subject in various places.