Audits

Having broad experience in auditing of API manufacturers as well as of contract medicinal products facilities we offer independent GMP (Good Manufacturing Practice) auditing services.

We also help in GMP system implementation (also in third countries) and we support our Clients in GMP inspections performed by competent authorities.

Our experts can help you in solving of existing problems trying to find an appropriate solution aiming at improving of quality.

In order to ensure the quality of non-clinical studies as well as bioanalytical assays in clinical trials all the mentioned studies should be conducted in accordance with the principles of Good Laboratory Practice (GLP). SciencePharma has an experienced team of auditors having broad knowledge in conducting of non-clinical in vitro and in vivo studies, as well as in performing analyses of samples taken from participants in clinical trials by using of both chromatographic and biological methods.

We offer auditing of quality systems for compliance with GLP recommendations, during which standard operating procedures and related documents are verified but also the organization itself, qualifications of staff, the way of studies conducting and records keeping. GLP audit system is a highly useful tool in the selection of subcontractors.

In accordance with the valid law and guidelines concerning Good Clinical Practice, audits in clinical trials of medicinal products, as well as medical devices, constitute an essential element of quality assurance system, that each Sponsor of a clinical trial must take care of.

SciencePharma possesses a qualified team of auditors, who have a broad knowledge in the terms of clinical trials. The acquired experience enables us to an independent assessment on each stage of a development project/study. We offer e.g., conduct of systemic audits, during which we verify the standard operating procedures and other quality documents, an assessment of potential vendors, processes or contracting activities, audits associated with a clinical trial, during its conduct or after its completion, as well. In order to improve the quality, we can propose introducing appropriate preventive or correction actions.

The new legislation on pharmacovigilance from July 2012 established legal requirements for the Marketing Authorisation Holder (MAH) to perform regular risk-based audits of its pharmacovigilance system. The guidance on planning and conducting the legally required audits are included in the Guideline on Good Pharmacovigilance Practices (GVP Module IV) of the European Medicines Agency.

Having adequately qualified and experienced auditors SciencePharma provides a risk-based audit services to provide independent, objective opinion on the MAH pharmacovigilance system.