Quality & Certification

Quality & Certification

The objective of Rotem’s quality system id to continuously produce and supply high quality products that comply with relevant regulatory requirements while simultaneously meeting the requirements and expectations of customers. This is implemented by every member of the Rotem team, all of whom bear responsibility for placing quality at the top of their priorities.

Regulatory certifications enable users to rely on Rotem’s products when submitting their own filings (marketing authorizations, DNA’s, etc.) with their relevant authorities. Rotem is certified as complying with the ICH Q7 Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical Ingredients, ISO 9001:2008 and ISO 13485:2003 standards.

4444
GMP
CEP
FDA

Quality & Certification

The objective of Rotem’s quality system id to continuously produce and supply high quality products that comply with relevant regulatory requirements while simultaneously meeting the requirements and expectations of customers. This is implemented by every member of the Rotem team, all of whom bear responsibility for placing quality at the top of their priorities.

Regulatory certifications enable users to rely on Rotem’s products when submitting their own filings (marketing authorizations, DNA’s, etc.) with their relevant authorities. Rotem is certified as complying with the ICH Q7 Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical Ingredients, ISO 9001:2008 and ISO 13485:2003 standards.

principles-mobile
GMP
CEP
FDA