Cosmo pharmaceuticals
Products Quality and Safety

Products Quality and Safety

How we grow, manage and develop our product offering is key to the ongoing success of Cosmo. We know the importance of building and nurturing relationships with suppliers, healthcare professionals and patients.

Providing Full Fair Information about Products

Building and maintaining strong relationships with healthcare professionals is central to our success. In pursuance of our objective to promote a free and fair market, Cosmo recognizes the need for healthcare professionals to make clinical decisions in the best interests of their patients and free from outside influence. To facilitate this, we provide focused medical and scientific information to assist the decision-making process around using our products.

Cosmo’s marketing messaging must be:

  • Balanced, unbiased, accurate and not misleading.
  • Consistent with approved labelling.
  • Be compliant with industry standards and best practice together with Cosmo’s policies and procedures and all applicable laws.

Employees of Cosmo are urged to familiarise themselves with local laws as how Cosmo’s messaging can be communicated may differ depending on location.

Global Trade Compliance

In pursuance of our strategy of working cohesively in the markets we operate in, we must comply with laws, regulations, licensing requirements and any embargoes set down by recognised national and international authorities.

It is a requirement of Cosmo’s work ethic that all employees:

  • Comply fully, accurately and honestly when providing information requested by the official authorities.
  • Do not conduct business with restricted parties or engage in restricted trade practices.
  • Familiarise themselves with Cosmo’s policies and procedures and applicable laws.

Commitment to Quality

The Group is committed to the development and manufacturing of products of high quality and to satisfy the expectations of its customers.

The quality system implemented at Cosmo meets the requirements and the expectations of the European and U.S. health authorities (EMA and FDA) for the manufacturing of drug products. Pharmacopoeias, pharmaceutical directives and guidelines (i.e. those issued by ICH) help to maintain the quality system at a high standard.

The quality system is fully in compliance with the current Good Manufacturing Practice (GMP) and allows the production of drug products of defined quality.

Products Quality, Safety and Adverse Events

The quality and safety of our products is core to our business. In order to achieve this and ensure patient safety, our products must be manufactured, stored and distributed in accordance with all applicable quality and safety standards.

Employee Training

It is our policy to effectively train and develop the knowledge and skills of all relevant staff as required to achieve a team of trained and experienced professionals. Employees receive initial and continual training on product quality and safety based on written procedures and in accordance with a written training programme. Employee competence in product quality and safety is maintained through rigorous and regular training.

As part of Cosmo’s commitment, employees are required to:

  • Ensure they have the required skills and appropriate competence to complete their tasks by attending and completing all training activities assigned to them.
  • Stay attuned with best practices and with Cosmo’s policies and procedures especially those containing applicable guidelines on how to deal with adverse events, product quality and product safety issues.

Public Reporting and Monitoring of Product Safety

Product safety is at the heart of everything we do. The labels on all our product packaging contains contact information to report any complaints or any possible product safety issues. Issues which are reported are investigated thoroughly. In accordance with regulatory requirements, we have written procedures and associated training programmes to ensure a consistent and thorough process for the collection, identification and reporting of all product safety issues is in place. All confirmed product defects and safety issues are reported to the relevant external regulatory authority, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Cosmo is committed to continuously monitoring all product safety issues. This is achieved through periodic managerial reviews of all complaints and product safety issues identified. In addition to this a post market surveillance is completed and includes the following:

  • Analysing the geographical distribution of the product.
  • Reviewing the number and nature of any complaints received per market.
  • Reviewing how many complaints were classified as safety issues and required reporting to the relevant regulatory authority.
  • Review of all feedback (positive and negative) received from customers and Key Opinion Leaders (KOL’s).

In order to adhere to Cosmo’s policies, all personnel are required to:

  • In accordance with regulatory requirements, ensure all complaints and safety issues are recorded and thoroughly investigated.
  • Ensure all confirmed product safety issues are reported to the relevant regulatory authority.
  • Ensure periodic reviews of all reported issues are completed, documented in a timely manner and effectively communicated internally.

Incident Investigation and Corrective Action

In accordance with regulatory requirements and based on written procedures all complaints and safety issues are recorded and thoroughly investigated. As not all complaints received represent actual product defects, complaints which do not indicate a potential quality or safety defect are documented appropriately and communicated to the relevant team for the investigation and management of complaints of that nature.

Complaints that do represent quality or safety defects are documented appropriately and, based on written procedures, a defect investigation is initiated. Based on the outcome of the investigation appropriate Corrective and Preventative Actions (CAPA) are identified, implemented and monitored.

All confirmed product defects and safety issues are reported, in a timely manner, to the relevant external regulatory authorities.

It is imperative that all employees at Cosmo familiarise themselves with all relevant regulations and Cosmo’s written procedures in relation to incident investigation and corrective actions.

Policy Commitment and Managerial responsibility for Product Safety

Cosmo’s Chief Manufacturing Officer (CMO) has overall responsibility for product safety and ensuring that our products are complaint with all applicable regulations and legislation. It is Cosmo’s policy to:

  • Acknowledge that all individuals involved in the development, manufacture and distribution of products affects the quality and safety of the final product.
  • As professionals, we are held accountable for the quality and safety of the product produced and distributed to our customers.
  • Maintain quality systems to ensure all activities are carried out in a state of compliance will all relevant regulatory and safety requirements.
  • Carry out regular managerial reviews of the quality systems to ensure on-going adequacy and effectiveness.
  • Provide the necessary resources and conduct regular managerial reviews to ensure the products procured and distributed are compliant with all relevant regulatory and safety requirements.

Our commitment to product safety extends to all employees and we request all personnel to:

  • Familiarise themselves with all relevant product quality and safety regulations and legislation.
  • Ensure they have the required skills and knowledge by attending all training activities relevant to your role.

Emergency Response Procedures to Ensure Product Safety

Cosmo has a robust Quality Management System in place. Detailed procedures are established to ensure a rapid, effective and coordinated response to emergencies. Mock product recalls are conducted on a periodic basis to test the procedures to quickly and effectively remove a product from the marketplace with minimal risk to public health.

To ensure the continuity of this commitment, it is necessary that all employees:

  • Familiarise themselves with the Quality Management System and all procedures regarding emergency responses and product recalls.
  • Ensure they have the required skills and understand their role and responsibility in the event of a product recall.

Product Objectives and Targets

Cosmo continuously develops and reviews safety and quality objectives for all our products. Numerous objectives and targets are set to measure and ensure product safety and quality including, but not limited to, the following:

  • Number of product complaints received
  • Number of Corrective and Preventative Actions (CAPA) raised
  • Number of product safety issues reported to regulatory authorities
  • Number of product recalls
  • Number of batch rejections in the manufacturing process
  • Number of import rejections during product distribution
  • Continuous product improvement
  • Customer satisfaction

Product quality and safety against these targets is periodically reviewed by the CMO and the senior management team. 

An inherent part of Cosmo’s initial and continual training is that all employees are knowledgeable regarding the Quality Management System and all procedures relating to establishing and reviewing product objectives and targets.

Product Safety Audits and Risk Assessments

Cosmo’s continued success depends on our ability to effectively manage safety and risk. Cosmo maintains a robust Quality Management System with detailed processes and procedures. The quality system is compliant with all relevant regulatory requirements and standards.

In addition to this Cosmo also complete the following:

  • Internal audits, as per the internal audit program, to ensure compliance with all product safety regulations and guidelines.
  • Supplier audits, as per the supplier audit program, to ensure high and consistent quality of goods and services.

Cosmo is also subject to external audits by the relevant regulatory authorities and suppliers, which additionally ensures the highest product quality and safety.

Cosmo is committed to a systematic process for the assessment, control, communication and review of risks to the quality and safety of products across the Product Life Cycle. This includes the following steps:

  • A prospective risk assessment is performed to assess and mitigate all risks detected. This consists of the identification of the hazards and the analysis and evaluation of the risks associated with exposure to these hazards.
  • A risk assessment report is created to assess the probability of a negative event arising and the impact severity levels associated with the event.
  • For any intolerable or unacceptable risks, appropriate action or control is identified and recommended.
  • The risk assessment report is then circulated for review and approval by senior management.
  • Risk assessment reports are routinely reviewed to ensure the effectiveness of controls, relevance of assumptions and to assess the emergence of any possible new risks arising from the newly introduced controls.

At Cosmo, we ask all personnel to:

  • Ensure all regulatory authority audits and internal audits are carried out in compliance with all regulatory requirements, standards and guidelines.
  • Familiarise themselves with the Risk Assessment Procedure. The process is essential in ensuring the continued quality and safety of our final products and must be adhered to rigorously.