Express Pharma

Role of regulations: Assuring quality, safety, compliance and success with pharma packaging

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The second day of the PPL Conclave began with an interesting panel discussion on Role of regulations: Assuring quality, safety, compliance and success with pharma packaging. The panel was moderator by SM Mudda, Director – Global Strategy (Technical) Micro Labs. Tripti Nakhare, Senior General Manager, Regulatory Affairs and Packaging Development, FDC; Pradeep Dhargalkar,Head Packaging, Unichem; Rajesh Mishra, Associate Director- Packaging Development and Dr Srinivas Arutla Head, VP-Production Development, Apotex Research were the panelists.

Before beginning the panel discussion, Mudda briefed the audience on the evolution and importance of choosing the right packaging material. He said, “Development in packaging has helped us in achieving operational excellence, cost reduction, patent compliance and globalisation. We cannot undermine the importance of packaging in product design and delivery either. It is the representative of the company. The company first speaks to its patients through its pack. So, it has significant importance in building the brand and image of the company.”

He asked Nakhare to throw some light on the regulatory requirements in packaging.  Nakhare informed that the regulations are across the packaging line. She said, “When it co mes to regulation and its impact on packaging, I would like to break it into three segments i.e. regulation on the production packaging, regulation on the material and regulation on  labelling. Production packaging has many guidelines like the orange book in Europe which describes what is expected on the packaging line, WHO NX 9, and Schedule M of Drugs and Cosmetic Act. More or less they all talk the same language. In the current scenario we are facing a lot of audit issues, the equipment or packaging machinery needs to be upgraded with time. Today, we cannot have PLCs or any software which has windows XP, it’s not accepted by FDA any longer. So, these are aspects that need to be kept in mind.”

Answering Mudda’s next question on new standards and  industry’s methods to cope with it,  Dhargalkar said that packaging technology as a whole has to assist in meeting quality standards before they change their standard of rating procedures.

Dr Arutla emphasised on QbD and its benefits to the product. He said, “In any product which is being developed, QbD needs to be considered. When we develop a product we focus more on primary packaging and formulation development. QbD is a systematic approach of product development keeping the end objective in mind with knowledge about the product and the process.”


Key takeaways

  • Packaging helps achieving operational excellence, cost reduction, patent compliance and globalisation
  • In any product which is being developed, QbD needs to be considered.
  • Packaging has significant importance in building the brand and image of the company

Mishra pointed out that while designing packaging, the patients, manufacturing ability and cost effectiveness should be kept in mind. He advised that just as we invest a lot in beautifying our packaging, a significant amount should be invested in innovation.

The panelists also informed about advancements in packaging material and evolving regulatory norms. They advised the industry to stay updated with these norms to remain regulatory compliant.

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