GxP Audits
At SciencePharma we have skilled experts experienced in conducting various GxP audits: GMP, GLP, GCP and assessment of Pharmacovigilance (PhV) systems. Audits can be performed remotely, or on-site.
Good Manufacturing Practice (GMP) audits and implementation
SciencePharma offers independent GMP auditing services. We perform audits of laboratories, medicinal products manufacturing sites, warehouses, manufacturers responsible for batch certification, manufacturing facilities of APIs, excipients and contract manufacturers and packaging materials (including places for sterilization of packaging materials) as well as bioanalytical laboratories in terms of compliance with GLP. Our experts perform DMF/ASMF assessment with full support in case of ASMF preparation and/or CEP procedure. We offer GMP and other quality problems troubleshooting and support in GMP system implementation (also in third countries). We support our Clients in GMP inspections performed by Competent Authorities.
Good Clinical Practice (GCP) audits
Among other services, SciencePharma acts also as the Contract Research Organization (CRO) for clinical trials. We are alsways aware and up-to-date with the GCP requirements and possess a qualified team of GCP auditors, who can perform independent assessment of clinical trial(s). We can help you in selecting the CRO to perform your study, or verify if the already selected CRO runs the trial appropriately. Our GCP services for clinical trials include
- Verification of Standard operating procedures (SOPs) and quality documents;
- Qualification of potential vendors;
- Verification of processes or contracting activities;
- Clinical trial audits (during conduct or after completion);
- Preventive or correction actions suggestions.
Good Laboratory Practice (GLP) audits
To ensure the high quality of nonclinical studies and bioanalytical assays in clinical trials, all the activities related to them should be conducted in accordance with the principles of Good Laboratory Practice (GLP). At SciencePharma we have an experienced team of auditors having broad knowledge in conducting of nonclinical in vitro and in vivo studies, as well as in performing analyses of samples taken from participants in clinical trials. We offer auditing of quality systems for compliance with GLP recommendations including the verification of standard operating procedures, related documents, study records keeping. We do also verify the organization and staff qualifications. It is worth mentioning that GLP audits is a useful tool in the subcontractors selection.
GMP/ Good Distribution Practice (GDP) compliance audits
At SciencePharma we provide GMP/ Good Distribution Practice (GDP) compliance audits including:
- Auditing active substances manufacturing and storage sites,
- Auditing medicinal products manufacturing sites for solid, semi-solid, liquid, sterile, or non-sterile forms,
- Auditing quality control laboratories, storage sites of medicinal products (including physical importation sites), and transport companies
- Audits of GMP/GDP compliance for Investigational medicinal products (IMPs) during IMPs manufacturing and distribution.
GVP audits – assessment of Pharmacovigilance (PhV) systems
Audits of pharmacovigilance systems, including risk-based audits of quality systems are one of the legal requirements put on MAHs to perform. The pharmacovigilance audit activities should verify the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities. At SciencePharma we have performed hundreds of GVP audits for both local and foreign Clients. Our GVP audits services include remote and on-site GVP audits, PhV audits of Local Points and support during PhV Inspections performed by the EU or non-EU Agencies.
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GVP Audits
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GMP Audits
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GCP Audits
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Auditing medicinal products manufacturing facilities in the EU and in third countries
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Participation in bioavailability/ bioequivalence studies