{ENGLISH} CHAPTER 4S1 POINTS TO CONSIDER FOR PLANNING AND DESIGN OF OSD FACTORY – PART 1

CHAPTER 4S1 POINTS TO CONSIDER FOR PLANNING AND DESIGN OF OSD FACTORY – PART 1

 

This summary emphasizes the importance of URS and CD in establishing specifications and quality in the early stages of the project.

 

1. Prologue

In Asian countries, some pharmaceutical companies will receive a blueprint from a third party (for example contractor) and directly start the design and construction. It may contradict PIC/S GMP, which requires pharmaceutical companies to be accountable.

The examples of some actual problems are as follows.

Actual Problems we often see,

Beta-lactam factory which doesn’t have a “Containment” device is located together with non-beta-lactam factory in the same site. pharmaceutical companies buy process equipment without any idea of annual production, layout, and any plan. Client doesn’t have clear URS but chooses a vendor by only considering the offer price. Some contractors don’t have enough capability.

Example:

A Beta-lactam factory that does not have a “Containment” device is located together with a Non Beta-lactam factory in the same location.

 

2. URS (User Requirement Specification)

In the implementation of the project, it is important to maintain the User Requirement Specification (URS) document as the main guideline, as set out in Appendix 15. This URS includes User Requirements (UR) as well as the results of the Conceptual Design (CD). In the CD document, you also have the opportunity to explain the policies that apply in the project. In addition, it should be noted that the cost of project work (PJ) can range from 30% to 40% of the total budget that has been set.

 

3. CD (Conceptual Design)…