New Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard which is identical with ISO 15378 : 2017 ‘Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001 : 2015, with reference to good manufacturing practice (GMP)’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on recommendation of the Hospital Equipment and Surgical Disposable Products Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

The text of the ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain terminologies and conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker, while in Indian Standard, the current practice is to use a point (.) as the decimal marker.