{ENGLISH} CHAPTER 4S2 RISK BASED C&Q – PART 2

CHAPTER 4S2 RISK BASED C&Q – PART 2

5. Lean Qualification Approach – Description for Each Document

a. SVMP (Site Validation Master Plan)

(1) Describe the outline flow of the project.

(2) Refer to URB for an overview of the project. However, the target items should be described.

(3) VMP does not need to be revised even if there is a change in the detailed design later.

b. CSVMP (Computerized System Validation Master Plan)

Describe the list of CSV Target Systems.

Describe system classification and Software categorization and validation approach.

Relationship between qualification and CSV.

c. URB (User Requirement Brief)

This is something “Input” for design.

We will get an RFQ from the client for General contractors. Then paste to this document.

We will follow the fixed chapter of the standard as much as possible.

d. GMPCAP/GMPCAR (GMP Compliance Assessment Plan/Report)

This document is a Confirmation between GMP and URB.

We should make a sheet of EU GMP Annex 1. & WHO GMP.

e. SCP/SCR (System Classification Plan/Report)

Choosing Validation (Qualification) targets from all systems.

Standpoints if the system affects the quality of the products.

f. CARP/CARR (Critical Aspect Review Plan/Report)

This document is for extracting GMP Critical aspects from the system (Facility and Process Equipment).

Sometimes it is very difficult for the facility to extract CA from CQA…