Quality System
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. 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, etc.) with their relevant authorities. Rotem quality systems complies with the ICH Q7 Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical Ingredients, ISO 9001:2015 and ISO 13485:2016 standards.
Medical imaging's main quality
principles are:
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 and assess potential .effect on product
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.
GMP
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 ISO 9001:2000, ISO 13485:2003 standards.
CEP
Rotem is regularly audited by Israely Ministry of Health (has MPR with EU) for mannose triflate and receives GMP certificate. Last IL MOH audit: 08/2019. Rotem is the only company currently listed in the EDQM website as holding a registered certificate for Mannose triflate.
FDA
Rotem medical imaging has several approved DMFs with US FDA. The unit is regularly audited by the FDA. Last US FDA audit was in 11/2019.
Quality System
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. 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, etc.) with their relevant authorities. Rotem quality systems complies with the ICH Q7 Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical Ingredients, ISO 9001:2015 and ISO 13485:2016 standards.
Medical imaging's main quality
principles are:
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 and assess potential .effect on product
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
GMP
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 ISO 9001:2000, ISO 13485:2003 standards.
CEP
Rotem is regularly audited by Israely Ministry of Health (has MPR with EU) for mannose triflate and receives GMP certificate. Last IL MOH audit: 08/2019. Rotem is the only company currently listed in the EDQM website as holding a registered certificate for Mannose triflate.
FDA
Rotem medical imaging has several approved DMFs with US FDA. The unit is regularly audited by the FDA. Last US FDA audit was in 11/2019.
