Quality /

Quality assurance

Quality assurance

 

Biotechpharma has a successful inspection track record by the authorities and our clients. Our Quality assurance (QA) department oversees production and quality systems and strives for continues improvement to meet newest requirements. Our main goal is to ensure that biopharmaceutical products are produced for our clients according to GMP requirements and are safe to be administrated by patients.  

Biotechpharma has a successful inspection track record by the authorities and our clients. Our Quality assurance (QA) department oversees production and quality systems and strives for continues improvement to meet newest requirements. Our main goal is to ensure that biopharmaceutical products are produced for our clients according to GMP requirements and are safe to be administrated by patients.  

 
Main Quality Assurance services:

  • Assurance of compliance with the Good Manufacturing Practice (GMP) requirements.
  • Staff training and compliance with the requirements of the quality assurance management
  • Organizing and conducting internal and external audits of the quality assurance management system
  • Organizing and controlling corrective and preventing actions of quality management
  • Management of documentation, change control, deviations, complains
  • Approval or rejection of Intermediates, active pharmaceutical ingridients (API) and drug products (DP)