Audit / Expert Review

Tarqvara Pharma Technologies offers a full range of auditing and expert services, including:

Conducting audits of pharmaceutical manufacturers, pharmaceutical distributors, API manufacturers, packaging material suppliers, equipment and software suppliers, and service providers for compliance with GMP/cGMP, GDP, GAMP, 21 CFR Part 11, ICH Q7, ICH Q10, ISO 9001, ISO 15378, ISO 13485, ISO 17025, and other standards, either on-site or remotely; supplier qualification.
Performing operational and technical audits of pharmaceutical enterprises (Due Diligence).
Analyzing documentation practices and records and data integrity (RDI).
Providing expert evaluation of design and technical documentation/specifications.
Reviewing design solutions for fire and explosion safety, microbiological safety, occupational safety (toxic production), safety in handling controlled substances (narcotics and psychotropic substances), cold chain integrity, and handling of products requiring special conditions.
Conducting gap analyses, developing recommendations and plans to achieve regulatory compliance, and assistance in preparing for regulatory inspections.

The specialists at Tarqvara Pharma Technologies have extensive experience conducting audits and expert evaluations in accordance with international, European, and national regulatory requirements and standards, with approximately one hundred completed audits of pharmaceutical manufacturers and suppliers of various materials and services for the pharmaceutical industry, including audits for the “big pharma” companies.