Toxicology compliance testing

Additionally, it must fulfil the general requirements for biocompatibility/non-toxicity of medical devices. The compliance with the global requirements affirms that generally accepted limits of toxicological standard tests are met [13],... 

These standards originally concerned animal safety studies today, they are applied to all animal studies, for example, toxicology, pharmacology and animal PK. GLP was legalized as an MHLW Ordinance in 21 March 1997, requiring in particular to establish SOPs and the preparation of protocols and study reports. PMDA is conducting GLP compliance reviews and on-site inspections of testing facilities. 

A (National) GLP Compliance Programme may cover only a limited range of chemicals, e.g., industrial chemicals, pesticides, pharmaceuticals, etc., or may include all chemicals. The scope of the monitoring for compliance should be defined, both with respect to the categories of chemicals and to the types of tests subject to it, e.g., physical, chemical, toxicological and/or ecotoxicological. 

Inspections for compliance with GLP Principles may take place in any test facility generating health or environmental safety data for regulatory purposes. Inspectors may be required to audit data relating to the physical, chemical, toxicological or ecotoxicological properties of a substance or preparation. In some cases. Inspectors may need assistance from experts in particular disciplines. 

Applicants to comply or justify non-compliance with extensive data requirements set out in the annexes to the directive the requirements include toxicology, ecotoxicology and efficacy testing. 

Consolidation is expected to continue due to margin pressures caused by regulatory issues such as FDA compliance, toxicological testing, environmental compliance, and the continual need for capital investment. This trend may be most apparent in the Asia/Pacific region where there are a large number of small suppliers. 

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