Quality Assurance Department

Quality Assurance (QA) department of Ottoman Pharma (Immuno division) is an independent department and working under the legally qualified and professionally competent pharmacist.

Quality assurance department ensures that

  • Drugs are designed and developed as per requirements of good manufacturing practices.
  • Production and control operations are clearly specified in a written form and good manufacturing practices requirements are adopted and followed.
  • Managerial responsibilities are clearly specified in job descriptions.
  • Arrangements are made for the manufacture, supply, and use of the correct starting and packaging materials.
  • All necessary controls on starting materials, intermediate products, and bulk products and other in process controls calibrations and validations are carried out.
  • The finished products are correctly processed and checked, according to the defined procedures.
  • Finished drugs are not sold or supplied before the authorized person(s) has certified that each production batch has been produced and controlled in accordance with the requirements of the good manufacturing practices and the relevant rules made under the Act relevant to the production, control and release of drugs as well as of conditions of registration.
  • Satisfactory arrangements exist to store in appropriate storage conditions.
  • Procedure for self-inspection and or quality audit exists and documented.
  • Written Standard Operating Procedure available according to which complaints about marketed products are examined, the causes of quality defects investigated, and appropriate measures taken in respect of the defective products and to prevent recurrence and that system is followed.