Audit of foreign and domestic pharmaceutical materials and factories related to GMP and GQP regulation
PAC conducts an audit of pharmaceutical materials and factories in accordance with medicine GMP and GQP regulation. We excel at auditing overseas factories through our experience overseas.
We perform a risk analysis including area characteristic and propose countermeasures in high-risk observation including conforming/non-conforming of a factory.
Audit of facilities on GVP, Pharmaco-vigilanse
In Japan, outsource is authorized by GVP and GPSP regulations. Also outsourcing self-inspection that is required its implementation is authorized. (GVP Q&A Article 11)
PAC has a wealth of knowledge about good vigilance practice and a significant background in self-inspection. In September 2008, Pharmacovigilance guidelines, (Volume 9A of The Rules Governing Medicinal Products in European Union –Guidelines on Pharmacovigilance for Medicinal Products for Human Use- -) were issued.
Therefore, the companies which release medicinal products into EU region are needed to crate corporate structures according to these guidelines.
PAC proposes services of facility audit in accordance with the guidelines.
Audit of domestic and overseas GLP facilities
“Standard of Good Laboratory Practice (GLP)” was come into effect in March 1997 stated in Health and Welfare Ministry Ordinance to Provide for Criteria Pursuant to item 21. Conducting tests on drug toxicity and safety based on this standard is required.
This standard applies to a test such as toxicity study. Other tests (of drug efficacy, pharmacokinetics, property and stability) are also conducted in conformity with the standard.）
On the other hand, OECD-GLP is becoming the world standard overseas, however United States, Europe or Japan has its own different definition of standard. In Asia there are little industries which develop medicinal products like Japan. Therefore, supporting OECD-GLP which is the first step of implementation control of agricultural chemical material tests is promoting.
PAC makes use of our wide experience about GLP examination in overseas facilities to provides audit services for not only domestic GLP facilities but also international. Our services are not just audit by confirming suitability. We detect risks in a facility as well as propose the countermeasure so that sponsors will be able to monitor afterward.
Audit of domestic and overseas GCP-CRO
“Good Clinical Practice (GCP)”was come into effect stated in Health and Welfare Ministry Ordinance to Provide for Criteria Pursuant to item 28 in March 1997 at exactly the same time as GLP Standard above.
A variety of outsourcing has been performed in clinical trials including medical writing such as protocol or report, facility monitoring, data management and statistical analysis.
Regarding outsourcing, PAC offers our service of CRO (Contract Research Organization) audit which is sponsor’s responsibility. In view of recent adverse market condition in Japan, clinical trials have been actively conducted overseas for developing in foreign markets. To overseas CRO, we also provide the similar audit services.
Audit of medical agencies conducting clinical trials (GCP)
PAC provides audit services for medical agencies conducting clinical trials within the GCP above. Audit services are implemented according to GCP for example whether trials are properly conducted as required by a plan document, subjects’ agreements are properly obtained, and side effects are properly informed.