Optimize validation cost

  • Optimize validation Cost
  • Heed regulator's advice
  • Prototype Preparation
  • Gear Up for the challenge
  • Go Regional
  • change management
  • Equip the new leader
  • Share the load
  • explore with us

A manufacturing facility learned that they were not ready for a PAI (pre-approval inspection). In a letter to the company CEO, the country regulator identified several key issues in their validation program and concluded by advising them to engage a consultant. That was what led the company director to contact us.

From reading the correspondence between the company and the regulator, we observed that the company had viewed the issues differently from the regulator. For some issues, the company had misinterpreted the regulator’s concerns.  For others, they had followed practices that were recommended by practitioners who were not familiar with requirements that were specific to the country that the company intended to export the products to. We highlighted what would be deemed as “red flags” to the regulators, what we could do to verify that the concerns were true, and how to manage them.

With the client’s agreement, we conducted on-site gap assessments. These provided the opportunity to help the client understand the specific requirements that they had not been complying with. The assessments also allowed us to identify the root causes to the non-conforming items.

This was followed by a facilitation session to get the team to create the action plan to close the gaps. The aim was to build their commitment  by helping them to understand the “Why” and “How” elements of the action plan.

We finished with providing technical resources to review the actions that were carried out, and also made provisions to bring experienced practitioners to train them in areas that were beyond the capability of the client’s team. The entire exercise was designed to build the competency of the team, which lacked experience on managing inspections. By working alongside with them and showing them the thought processes, the confidence of the team was much improved after the entire process.

Audentiq: GMP partner to Asia’s biopharma and medical device manufacturers

Audentiq supports the drug and device manufacturers in the areas of quality, sterility assurance and laboratory compliance. We help start-ups and growing companies in Asia to build and enhance their  capabilities to serve the global market.

Nurtured by the noble aspirations of the biomedical community, we are grateful for the privilege of serving Asia to bring safe, effective and affordable healthcare to the world.

We are located at:

7 Temasek Boulevard, Singapore 038987