In the medical and pharmaceutical industries, the printing and labeling of products and packaging must be reliably recorded and checked in order to prevent product mix-ups due to mislabeling and to ensure the traceability of ingredients and end products.
The FDA requirement 21 CFR Part 11 or the EU Gmp Guide Annex 11 is decisive for the requirement for electronic data records and electronic signatures in relation to production monitoring.
GAMP is the abbreviation for Good Automated Manufacturing Practice and means “good manufacturing practice”. This is the guideline to ensure the quality of the production of, for example, pharmaceuticals, active ingredients, cosmetics and food. In addition to production, the GAMP guideline also sets quality requirements for processing, packaging and storage.
If the GAMP guidelines are not complied with, companies are not allowed to manufacture the corresponding products.
The most important regulatory basis is the standard 21 CFR Part 11 on electronic data records and electronic signatures of the US Food and Drug Administration (FDA). Other country-specific and industry-specific regulations also apply.
Various regulations regarding the traceability and documentation of production data apply in sectors such as the pharmaceutical industry or the food and beverage industry. These include the following provisions:
It must be ensured that
The requirements for the camera system contained in these documents are fully met by i-mation GmbH with the GampBOX.
Would you like to find out more about our GampBOX for the medical and pharmaceutical industry? Just give us a call or send us an e-mail.
info@i-mation.de
Tel. +49 741 942 286-00
i-mation GmbH
Neckartal industrial estate
Neckartal 250
78628 Rottweil
+49 741 942 286-00
+49 741 942 286-90
info@i-mation.de
