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PDA India sees need for strict implementation of global regulations by pharma shop floor personnel
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Nandita Vijay, Bengaluru
February 22 , 2023
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Parenteral Drug Association (PDA) India Chapter now sees the need to ensure stringent implementation of global regulations by pharma and biotech shop floor personnel. This is because much of the challenges emanate from the negligence of shop floor personnel. There is need for rigorous training, persistent persuasion and continuous monitoring to ensure total adherence to global regulations, said Vishal Sharma, president, PDA India Chapter.
In this regard, we are looking to collaborate with various regulatory and scientific bodies to bring industry best practices to fruition. To this end, we will be working closely with industry on education of their staff. We have formed a group of local and international subject matter experts representing more than 65 of them from industry to develop a curriculum for practical training in the country. This is a first-of-its-kind in the country. The effort is to bridge the skill-gap of the trained manpower which is industry is facing, he added.
The trend on the pharma production landscape is aseptic manufacture and sterile fill-finish. This mandates adherence to highest quality process for parenteral drugs covering the gamut of vaccines, biologics, injectable drugs, oncology drugs, ear drops, nasal spray, and eye drops which needs to ensure complete safety to be efficacious on patients.
At a the ongoing two-day PDA India Chapter meeting titled Regulatory Expectations: The Quality Advantage, was a platform where the senior teams of the US FDA and EDQM interacted with the industry.
According to Sharma, the need of the hour is to put in place systems for appropriate manufacture. This needs routine and effective supervisory for all production batches to stall any oversight. We see education and training to play a paramount role as it creates awareness and imparting knowledge to mould the production workforce to be responsible and conscious.
The PDA India chapter is focused on building capacity and capabilities for Indian sterile manufacturing. We have started PDA's world renowned training courses in India at a hands on training facility, christened as Brooks the learning center at Gauribidanur near Bengaluru. This full fledged manufacturing plant is a training ground for pharma workforce. The hands-on training and guidance by the regulatory and industry experts makes them adept in good operational and maintenance. It also inculcates a sense of accountability among the personnel to adhere to practices and procedures, Sharma told Pharmabiz on the sidelines of the event.
PDA India was formed in 2013 and in 2019, we set up this dedicated facility for training centre. From April 2022 till now we have conducted over 28 programmes. This provides the participant the much-needed experience of actually working in a pharma manufacturing unit which has filling lines, autoclave among others installed. The training is intensive and comprehensive. Following the success of the programmes, we spoke to US FDA India officials to replicate their training of what is done in the US in India at Bengaluru. US FDA India office team organised an ad-hoc training for 40 pharma industry personnel. There are several programmes of this kind taken up in the US and in India the intent was to ascertain the response for similar exercise which turned out to be positive. Therefore going forward, we expect more such training from US FDA India, he said.
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