Quality management

The Company’s Quality Control and Quality Assurance systems are implemented throughout all the stages of the product lifecycle.

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Sopharma AD owned a comprehensive model for an effective pharmaceutical quality system that is based on International Organization for standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations, and complements ICH “Q8 Pharmaceutical Development” and ICH “Q9 Quality Risk Management.”

Our quality management system implemented throughout the different stages of a product lifecycle.

  • We believe as soon as we think that “good is good enough” we are in trouble.
  • We are constantly challenge, question and improve.
  • We are focused to develop excellence in our processes and products, risk-based decision making, problem solving, error reducing and auditing.

Sopharma AD as a manufacturer of various products exercises continuous effort for improvements internally. With strong sponsorship from executive management and effective communication throughout the organization this spirit of collaboration ensures that a solution is achieved. Such an approach not only reflects on best manufacturing practice but also an ideal fit for our clients and ensures sustainability since the client is part of the solution.

As parts of Quality Management, the Company’s Quality Control and Quality Assurance systems describe the methods, the controls, the equipment and facilities that are into place for the manufacturing of pharmaceutical products. The ongoing auditing program verifies continuous compliance to GMP standards, appropriate training of employees and efficiently use of resources.

The quality control laboratories - chemical and microbiological - of Sopharma AD are certified by the Bulgarian Accreditation Service for testing of raw materials, active substances and excipients and medicinal products according to ISO 17025.

The Quality control laboratories are equipped with modern equipment for conducting different types of pharmaceutical analysis.