Our 3P Philosophy


Any system success can be attributed to its effective enforcement by people. On the other hand, for system failures people’s factors may, too, be a key. Our approach to system improvement starts with optimizing team performance. Many people-related weaknesses can be identified, such as bench skills, documentation, critical mass, reporting lines, knowledge scope, communication, etc. Once the causes are known, the problems are halfway solved.


A process is a summation of continuous efforts in given time frames towards set objectives. It is beneficial to invest in process design and optimization. A robust process can buffer uncontrolled changes therefore assuring output with desired quality. It can also flag the trends for people to watch for and act upon. In our view, this is the essence of GMP. Aspects of a GMP process may include the following and more:

  • Management Structure
  • Quality system and surveillance
  • Technical merit
  • Qualified personnel
  • Documentation
  • Supply chain
  • Analytical methods and controls
  • Facility and equipment suitability
  • CAPA
  • Communication
  • Regulatory participation and compliance


The ability to anticipate and prevent definitely reflects what we call “business maturity”. Prevention is less expensive than repair as some damages may not be repairable. In product lifecycle management, prevention also means to look out and take measures to meet changes. The changes may be voluntary of internal initiations and involuntary due to regulation changes and trend shifting. In essence, anticipatory and preventive measures play a vital role in maintaining business continuity.

Our 4I Approach


Time is the essence. To the extent as it is feasible, we can offer immediate assistance to clients. We can generate responses on behalf of clients in urgent situations to minimize potential negative impact to businesses; in furthering the process, we can assist clients to manage issue resolutions and log proper documentation for the purpose of regulatory review and verification.


But for sustained quality assurance and robust regulatory compliance, we prefer a calm and well-designed system to operate. To this effect, we assist clients to look for deep-layer causes underlining the quality deficiencies and identify system vulnerability. The responsibility sphere will be sketched and used to assign tasks. The findings are grouped based on compliance framework to help lay out a detailed corrective plan for execution which determines why (to change), who (to participate), what (to do), where (to do) and when (to complete).


We promote communications in multiple forms and formats. Compliance enforcement process aught be an interactive one relying on inputs from multiple parties. A mobilization of employees and management toward fostering compliance culture is very helpful for quality sustainability and certainly beneficial for business.


Implementation of a well-crafted CAPA plan should bring the quality system back to health. In the hands of a team with objectives well understood, the implementation should go smoothly; Do not forget that verification of effectiveness is part of the implementation. Hence in a broader time frame for product lifecycle management, it is important to always stay current with science advancement and regulation changes in order to make right moves timely