【Compliance with GMP ordinances】Rules, Procedures, and Forms for Introduction of Structural Facilities

The GMP Ministerial Ordinance was revised and went into effect on August 1, 2021.
This revision is a major amendment.
eCompliance sells a collection of regulations, SOPs, and forms that comply with the requirements of the revised GMP Ministerial Ordinance.
Since they are in MS-Word format, they can be added or modified to suit your company’s operations and processes.

Please contact us if you would like to see a sample.

List of Forms
The following forms are included with your purchase.
【Compliance with GMP ordinances】
・PH-QMS-PCK20 Rules for Installation of Structural Equipment
・PH-QMS-PCS2001 Structural Equipment Installation Procedures
・PH-QMS-PCF2001 FMEA sheet
・PH-QMS-PCF2002 Facility Qualification Plan
・PH-QMS-PCF2003 DQ Implementation Results
・PH-QMS-PCF2004 IQ OQ Implementation Results
・PH-QMS-PCF2005 PQ Implementation Results