Regulatory requirements Good Clinical Practice

Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements and the applicable regulatory requirements - this is how ICH GCP (1995) defines compliance. 

Clinical trials are performed under Good Clinical Practice (GCP). Up to now, there has been no reference to the regulatory requirement. The reality is that every trial has to be approved and carried out under regulatory compliance to GCP requirements. Otherwise, the trials may be considered as noncompli-ant and become invalid. 

The logistics of large phase 3a trials are extremely complicated and require considerable manpower in the headquarters and in the field. Full compliance to Good Clinical Practice (GCP) as well as scientific integrity are prerequisites for the acceptability of these trials to the regulatory authorities, and the pivotal trials undergo detailed inspection to safeguard these... 

Alternatively, the quality audit may be conducted on-site. Again, the audit can be as extensive as a comprehensive GMP, Good Laboratory Practice (GLP), or Good Clinical Practice (GCP) systems audit that reviews all regulatory requirements for strict compliance, or simply a visit to ensure that... 

Quality Assurance (QA). All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s). 

Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). Annotated with TGA comments. Therapeutic Goods Administration [TGA] (Australia), Commonwealth Department of Health and Aged Care. The TGA has adopted CPMP/ICH/ 135/95 in principle but has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of local regulatory requirements , July 2000. http //www.health.gov.au/tga/docs/html/ ichl3595.htm. 

All formulations for administration to humans must be prepared in compliance with good manufacturing practice (GMP) and the certificates of analysis must be provided. The European Clinical Trials Directive requires that details of the formulations be provided to, and approved by, regulatory authorities and a qualified person at the investigator site(s). In principle, the Directive has been in force throughout the EU since May 2004 though it has been implemented at various times in different member states. The Directive applies to healthy volimteer as weU as patient studies. The requirements for pharmaceutical products for administration to humans are summarised in Box 4.6. 

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