Argentina: checklist for GMP inspections of API facilities

On the 3rd of September 2013, ANMAT (regulatory agency in Argentina) issued a new Disposition establishing the guidelines and checklists that will be used by its inspectors for GMP inspections of sites of manufacturing, elaboration, fractionating, distribution, commercialization, exports and imports of Active Pharmaceutical Ingredients (APIs).

This new checklists are based in ICH guidelines and include several items of the following aspects: Administration and General Information, Human Resources, Building Structure and Installments, Services Systems, Computarized Systems, Documents and Registers, Material Management, Production and in-Process Controls, Conditioning and Labeling of APIs and Intermediate Products, Storage and Distribution, Quality Control, Validations, Change Management, Rejection and Reutilization of Materials, Complaints and Market Recalls, Contract Manufacturers and QC Labs, Agents, Intermediates, Marketers, Distributors, Repackagers, APIs obtained by Cell Culture of Fermentation Methods, APIs for use in Clinical Trials and Quality Assurance.

The Disposition also includes the potential measures to be applied in case of deficiencies, from programed corrective measures to close-down of the facilities, indicating which deficiencies will bring what outcomes.

Advertisements

About Maria I. Guaia

www.latampharmara.com
This entry was posted in Argentina, Uncategorized and tagged , , , , , , . Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s