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 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.
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EH & S
The environmental and occupational health aspects of our operations are vitally
important for us and they are well integrated into our Quality System.
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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.
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."
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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 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 by
several different bodies without incident.
Our staff has diverse backgrounds as chemists, biologists, chemical engineers, pharmacists,
environmental scientists and technicians and are continuously being trained in good
manufacturing and laboratory practices as well as new laboratory instrument technologies.
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