Good Manufacturing Practice (GMP) experts can work to evaluate systems at your pharmaceutical, biotechnology, or medical device organization or at your vendor sites to determine if the systems in place are sufficient to meet your manufacturing needs and the current regulatory standards. We are able to conduct audits on your behalf, using your established audit program or our process, whichever works best for your needs.
Our GMP experts have experience auditing systems against applicable regulatory and industry standards. Our experts work with you to apply the correct standards based on your needs, the activities or services provided, and the stage of your project. During our evaluations, we can identify areas for improvement or potential compliance risks. We assess a wide range of systems—most notably those used in quality, production, packaging and labeling, materials, laboratories, distribution, and equipment and facilities.
Our consultants have extensive knowledge and experience in all aspects related to quality management and quality assurance in particular with the requirements of GMP, GDP. We can assist you in:
- preliminary audit and analysis of Quality Assurance System documents
- elaboration and implementation of necessary documentation of Quality Assurance System according to Good Distribution Practice
- audit of technical documentation, elaboration and implementation of Validation Policy
- transport cost analysis, profitability of transport routes
- performing of GMP audits of medicinal products manufacturing plants
The independent audit gives the objective insight into the clinical research projects and provides objective information about credibility/ compliance of the research data and efficacy of operational processes including project monitoring and management, safety, data processing. Clinmark’s experts have extensive knowledge and experience in all aspects related to quality management and quality assurance in particular with the requirements of GMP, GDP, GLP. Regulatory inspections of clinical trials are an integral part of pharmaceutical industry life. Clinmark’s professionals support Clients in the preparation to the inspection and lead them through the regulatory inspections. Our expertise consists of a pre-inspection gap and weaknesses identification in the research processes and research documentation, mock inspection of investigational sites and Sponsors’ departments, training of investigators’ and Sponsor’s staff, hosting the inspection on Sponsor behalf, preparation of responses to inspection observations and last but not least, the implementation of CAPAs. Clinmark offers comprehensive support for preparation for GxP inspection tailored to the needs and expectations of a Client. The GxP audits are conducted by Clinmark’s experienced auditors. Receiving EU GMP Certification is highly valuable for companies, because it gives them a competitive advantage and confirms, that they manufacture compliant high quality drugs. Clinmark performs GMP audits at a number of plants around the world to ensure compliance with GMP guidelines and covers a lot of products.
Clinmark has possibilities to perform all above mentioned services in over 60 countries of the world by very experienced and professional auditors.