The objective of Rotem’s quality system is to continuously produce and supply high quality products that comply with relevant regulatory requirements while simultaneously meeting the requirements and expectations of customers. The quality culture 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 (DMF’s) enable users to rely on Rotem’s products when submitting their own filings (marketing authorizations, etc.) with their relevant authorities.
Rotem quality systems complies with the ICH Q7 Good Manufacturing Practice (GMP) Guidance for the Active Pharmaceutical Ingredients, Annex 1 for the sterile product and ISO 9001:2015 & ISO 13485:2016 standards. Rotem Industries‘ factory has been inspected by the Israeli Ministry of Health, FDA, and many customers.
Provide safe and effective products for customers, a safe working place for employees and effective production by controlling and documenting the entire production and control process.
Devote appropriate resources to enable manufacturing of quality products.
Strive for continuous improvement of products and processes while implementing a change control program to prevent unintended consequences of change.
Where possible, prevent deviations and malfunctions and where not, report and correct the problem, assess the potential impact on the product and finding the root cause for preventive recurrence.
Work as a team with interdepartmental cooperation.
Educate and train employees to ensure that company policy and work procedures are understood and to encourage active commitment to meeting the aforementioned goals.
Medical Imaging’s quality policy is based on its commitment to produce high quality products which is achieved by the implementation of the Q7 Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical Ingredients and Annex 1 for the sterile product and ISO 9001:2015, ISO 13485:2016 standards.
Rotem is regularly audited by Israeli Ministry of Health (has MPR with EU) for mannose triflate and HCl 0.1N and receives GMP certificate.
Rotem is regularly audited by Israeli Ministry of Health (has MPR with EU) for mannose triflate and receives GMP certificate. Rotem is the only company currently listed in the EDQM website as holding a registered certificate for Mannose triflate.
Rotem Medical Imaging has approved DMFs with US FDA. The unit is regularly audited by the FDA.