Requirement of Active and Passive Air Sampling in Controlled Areas

What is VMP
Brief information about Qualification, Validation and calibration of Equipment, Instrument and System.
A document providing information on the company’s validation work programme. It should be define
details of and timescales for the validation work to be performed. Responsibilities relating to the plan
should be stated.
2.2
Which Guideline follow for preparation of VMP
PIC/S (PI 006), WHO TRS 961, Eudralex Volume 4
2.3
Contents of VMP.  Cover Page, Table of contents  Approval of document  Introduction, Objective, Scope  Quality policy
 Validation policy
 Quality Risk Management Policy
 Responsibility
 Validation / Qualification Schematic Flow
 Validation and Qualification approach
 Revalidation and Requalification approach
 Qualification Activity
 Facility Qualification
 Qualification and Validation of Utilities  Equipment Qualification
 Laboratory Instruments and Equipment  Personnel Qualification
 Products and Process Validation
 Exhibit batches process validation
 Cleaning Validation
 Analytical Method Validation
 Hold Time Study
 Computerized System Validation
 Vendor Qualification Program
 Change Control, SOP, Training, Environment Monitoring, Preventive Maintenance /
calibration
 Terms and Definitions  List of Annexure  Revision History
 References