Advancement in regulations and pharmaceutical technology go hand-in-hand, said Dr Milind Joshi, president, Global Regulatory Management, JB Chemicals & Pharmaceuticals Ltd.

“Regulations change with advancing knowledge. Therefore, what the industry should do must be based on need and not on what is being done. The reality is that the need for regulations is risk-based,” he added.

Regulatory approvals rely mainly on data presented to the authorities in the form of dossiers. There is both data documentation and life-cycle management covering data generation, compilation, data integrity, developmental data, data management and electronic data. All these begin from the early stages of development through validations till stability, said Dr Joshi, in his keynote address at the recent DIA conclave.

“Technological advancement at each stage is now aimed at avoiding manual errors and purposeful slip-ups. This is where the industry should mandate data archival in electronic media formats to handle vast records,” Joshi said.

Currently, data compilation is viewed as a skill because it is based on the understanding and perception of guidance. Efforts are made to harmonize dossier structure, search ability, presentation of concise data without repetition and ease of cross reference, pointed out Dr Joshi. “However, it must be noted that technological advancement is double sided sword because on the one hand data integrity is seen as ethical and on the other hand it comes with a risk element,” he added.

Nevertheless, the biggest advancement in electronic data management is that it is accurate information which can be archived and retrieved to be made available anytime and anywhere. Moreover, it is both cost and time effective. There is also a parity between submitted and generated data, he pointed out.

Further, Dr Joshi, opined that harmonization and globalizations were due to advancements in technology. The various regulatory agencies: WHO, ICH, PIC/S, EMEA, ASEAN broadly call for similar requirements but with subtle differences. “But all regulators call to move towards Quality by Design (QbD) than QC/QA (quality control/ quality assurance). In the case of ICH Q8, Q9 and Q10, the norms mandate quality built into the product, continuous improvement, product-process understanding, product review, statistical analysis, risk analysis, assessment and mitigation. There is also considerable focus on automation covering Good Automated Manufacturing Practice (GAMP) which is a set of guidelines for the pharmaceutical industry. Therefore ample importance is given to robotic technology. Concepts like need for Design of Experiments (DoE) helps create the requisite design space.”

For the robust monitoring of pharmaceutical powder blend quality, combined Process Analytical Technology (PAT) tools with spectroscopic techniques like near-infrared (NIR) and Raman spectroscopy are implemented for online monitoring and process control. “These techniques are aimed at achieving assured product quality and to avoid human errors. However, all these would necessarily increase cost. But advancements in technology and regulation should aim at betterment of society. For this, pharma industry needs to ensure a balance between requirement and optimum regulation, said Dr Joshi.