Hi all,

Need advise - we have been molding parts for medical devices for a long time and most of our customers are happy with our quality management systems aligned as per ISO 13485.

Now, we are having a new cusotmer for whom, we will be molding parts for a vaginal applicator and he has told us to get certified as per ISO 15378 standard.

I checked the scope for ISO 15378 and it states - This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products, while

ISO 13485 scope states - This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.

In the past, we have been producing some inhalers, plastic containers for Tablets etc but no customer insisted on this ISO 15378.

If thats the case, would all devices containing any medication fall under the scope of ISO 15378 ? Any guidance highly appreciated. :thanks:

Now, we are having a new cusotmer for whom, we will be molding parts for a vaginal applicator and he has told us to get certified as per ISO 15378 standard.

In the past, we have been producing some inhalers, plastic containers for Tablets etc but no customer insisted on this ISO 15378.

If thats the case, would all devices containing any medication fall under the scope of ISO 15378 ? Any guidance highly appreciated. :thanks:

Hi Qualityalways,

The thing is that you have probably mostly produced secondary or tertiary packaging in the past, or packaging for medical devices. Now you are being met with the requirements for primary packaging for pharmaceutical production.

I think you would be well advised to make a gap analysis of your system compared to the 15378, probably you will find that you already cover most of it in your existing system.

Whether or not your company should then pursue certification is an economic and a management consideration. It does cost to acquire and maintain a certification, but the upside is that you can expand your activities into this area.

From the SQS website:

The standard specifies the requirements for a quality management system as well as the applications for design, manufacture and supply of primary packaging materials for medicinal products.
As a consequence of the direct contact of the product with the packaging (contamination risk), the implementation of GMP in production and the control of primary packaging materials are of high importance for the security of the patients.
The application of GMP for pharmaceutical packaging materials guarantees that the legal requirements and the standards of the pharmaceutical industry for medical devices are met.
The certification of a company according to ISO 15378 confirms that the GMP rules are applied and that the company operates based on an effective and efficient management system.


Best of luck

Thanks Gert, but I was wondering would the molding of the vaginal applicator be applicable under ISO 13485 or ISO 15378 ?

The tablet applicator is a Class I medical device under Sec. 884.4520 Obstetric-gynecologic general manual instrument, with Product Classification code as HGD.

Basically, I am trying to correlate if this device falls under the scope of ISO 15378 or ISO 13485. :confused:

This is not my field of use - or expertise - so I am guessing here (aided by my RA department). If the applicator goes inside the female body then it is a device under 13485. If it does not, then it is a container under 15378. :bigwave: