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Our Products and Services

1.1             Quality Standards & Good Practices

Adhering to quality standards and good practices is a precondition to get and sustain our license to operate. Safwan maintaining high-quality standards is essential for our business from assuring the new product approvals to maintaining our reputation with patients and health authorities. Quality is every patient’s right and every employee’s responsibility. Quality is engrained in everything we do, from concept through continuous improvement. Safwan is committed to complying with legal and regulatory requirements, internationally acknowledged good practices, e.g. quality management system and to meet the high expectations of its stakeholders regarding the quality, safety and efficacy of its products and services.

Safwan has established a quality system including sets of quality standards and procedures that employees must follow. In addition, employees must report any deviations from our standards to the Head of Quality Assurance.

Safwan expects that its business partners also adhere to its high-quality standards.                 

Patient safety and timely reporting of any adverse events and product complaints are of the utmost importance. Safwan employees have been trained to, upon awareness, immediately report any adverse event to their Pharmacovigilance Manager and any product complaints to Head of Quality Assurance.

An adverse event is defined as any untoward medical occurrence in a patient subject administered a pharmaceutical product for any of our multinational supplier and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An adverse event may include but is not limited to drug overdose (accidental or intentional), death, drug abuse, lack of efficacy or withdrawal symptoms.

Medical device reporting requires the reporting of any product complaint. A product complaint is defined as any written, electronic or oral communication from a customer/end-user that alleges a deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a Safwan medical device after it is distributed to the commercial market.

We are all expected to:

  • Comply with expected good quality standards and acknowledged good practices.

  • Ensure that our business partners adhere to our high-quality standards.

  • Immediately report any adverse event to the Pharmacovigilance Manager/LSO and product quality complaints to the Head of Quality Assurance for all products marketed by Safwan.

     

Example:

1.       While surfing the Internet, I discover a social media site on which a patient mentions that since she started taking ‘Product A’ which Safwan is already distributing, she started to experience headaches. Do I have to report that?

§  Yes, you should report it to Pharmacovigilance Manager as this is an adverse event with the following criteria: Patient/End-user, Reporter, Event and Product.

 

2.       While surfing the Internet, I discover a social media site on which a patient/end-user mentions that he had a bad experience/complication with one of our products which had cracks in ampules. Do I have to report that?

§  Yes, if you become aware of such information, you should report it to the Head of Quality Assurance. This includes information from the websites. You should report at least the following four elements: Patient/End-user, Reporter, Event and Product.

*Refer to Safwan’s Handling of Single Case Report Policy for more information and details.

*Refer to Safwan’s Handling Product Quality Complaint Policy for more information and details.

 

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