Quality Assurance
Our "First-in-Class" performance in Quality and EHS is achieved by rigorously applying a Safety and Quality Policy supported by an extensive hierarchy of Standard Operating Procedures, Guidelines and Standards as a token of our dedication to full client service. read more..

Environment, Occupational Health and Safety
Whilst producing drugs to render service for human health, it is essential to protect the environment and our employees’ health as far as possible. This aspect is for us as important as the achievement high quality production. read more..

The Quality Control Department is pioneering in an area other than the traditional QC functions of checking the quality of all starting materials, active ingredients and excipients in addition to the finished drug product. Presently a full third of the QC personnel is permanently stationed in the production area. This proximity fosters daily exchanges between quality and manufacturing and helps identify and rectify inherent weaknesses of processes and products but also of testing systems, check points and frequencies. Highest satisfactory analytical performance can be ascertained by monitoring various performance indicators such as percent of analytical validation, duration of analysis, etc.

Relying less on terminal tests, and instead more intensively controlling the process parameters during manufacturing leads to compliant products which can theoretically be released without final testing. This type of integrated QC system can justify the implementation of parametric release and PAT (Process Analytical Technologies), an area where Topkapı has quite a bit of expertise. This is definitely the way of the future and already the European Commission’s final version on parametric release, as in Annex 17 to EU GMP Guide and to PIC 2002, it is recognized that "a comprehensive set of in-process tests and controls may provide greater assurance of the finished product meeting specification than finished product testing."

The Analytical, In Process, Microbiology, Packaging Material Control and Environmental Labs are suitably equipped with state-of-the-art instrumentation to provide the customer with a comprehensive array of pharmaceutical analysis services including analytical, release, analytical validation, dissolution profile, bioequivalence and stability testing as well as microbiological capabilities including environmental and hygiene monitoring.

Our testing procedures are validated and our laboratory operations have been audited with successful results by several different bodies.

Our staff has diverse backgrounds as chemists, biologists, chemical engineers, pharmacists, environmental scientists and technicians and are continuously being trained in good manufacturing, laboratory practices and new laboratory technologies.

Our "First-in-Class" performance in Quality and EHS is achieved by rigorously applying a Safety and Quality Policy supported by an extensive hierarchy of Standard Operating Procedures, Guidelines and Standards as a token of our dedication to full client service. read more..