GCP Inspections
GCP is the system of internationally accepted ethical and scientific requirements which have to be taken into consideration during planning, executing, certifying and reporting any human clinical trial – it includes bioavailability and bioequivalence investigations as well. The human rights, safety and protection of state of health of the participants are provided by meeting the requirements of GCP. It also ensures that the trials are well-established and valid.
The National Institute of Pharmacy makes certain by their inspectors at the local inspections whether the research place meets the requierments prescribed by laws and directives. All inspections are carried out at the research places- these include all places where any activities relating to the investigations are proceeded. Accordingly the research place may include the seat of the investigator, sponsor/CRO, the research laboratory or the manufacturing place of the investigated products.
The GCP inspections may be carried out due to a schedule, however an exceptional inspection may also be necessary occasionally (e.g. if divergences from laws and regulations make new questions arise). The inspection of the research place may be carried out in any phase of the investigation: consequently during preparing for the investigation, in the course of the investigation, and after closing the investigation as well.
While preparing for the inpsection the following data and information may be necessary:
The GCP inspections may be carried out due to a schedule, however an exceptional inspection may also be necessary occasionally (e.g. if divergences from laws and regulations make new questions arise). The inspection of the research place may be carried out in any phase of the investigation: consequently during preparing for the investigation, in the course of the investigation, and after closing the investigation as well.
While preparing for the inpsection the following data and information may be necessary:
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data of the participants separately for all research places (number of participants, randomization, rate of dropped-outs, serious adverse effects-SAE);
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instructions referring to the process of investigation (e.g. monitoring, consent declaration, serious adverse effect (SAE) reports, tasks with the investigated product);
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individual documents concerning the investigation (e.g. validation of sources, checking the individual data sheets, Standard Operating Procedures, validation documents of measuring instruments, randomization code-breaking procedure);
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information regarding manufacturing and tranpsorting of the clinical sample.
The research places are always notified about the inspection well in advance.
