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-PCK4 Process Validation Rules
・PH-QMS-PCS4 Process Validation Procedure
・PH-QMS-QSF401 Facility Qualification Implementation Plan
・PH-QMS-QSF402 DQ Implementation Results
・PH-QMS-QSF403 IQ Implementation Results
・PH-QMS-QSF404 OQ Implementation Result
・PH-QMS-QSF405 PQ Implementation Result