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-QSK12 Regulations Concerning Information on Quality, etc. and Treatment of Quality Defects, etc.
・PH-QMS-QSS1201 Procedures for Information on Quality, etc. and Actions on Quality Defects, etc.
・PH-QMS-QSF1201 Quality Information Communication Form
・PH-QMS-QSF1202 List of Quality Information
・PH-QMS-QSF1203 Quality Information Form
・PH-QMS-QSF1204 Record of Quality Defects, etc.