Quality documentation
Creation or updating of the quality manual, SOPs, manufacturing and testing specifications, quality agreements (Quality Agreement) and the entire document hierarchy.
Quality assurance consulting (GMP, GDP, GLP)
We support compliance with pharmaceutical regulations by establishing a documentation system that meets the requirements of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Laboratory Practice (GLP), by reviewing existing quality assurance systems and by conducting preparatory audits.
Our goal is that our partners can confidently face regulatory (OGYÉI, NÉBIH, FDA, EMA) inspections, and that their quality system not only complies but also makes daily operations more efficient.
Gap analysis and preparatory audit
Objective assessment of the existing system in light of current regulations, identification of deficiencies, followed by self-inspection and mock inspection before the regulatory review.
Deviation and CAPA management
Establishment of deviation handling, complaint and recall, as well as corrective and preventive action (CAPA) systems, and introduction of root cause analysis methodology.
GDP in wholesale
Support for the Responsible Person (RP), temperature mapping, transport validation, supplier and customer qualification according to Good Distribution Practice.
Frequently asked questions
What is the difference between GMP, GDP and GLP?
GMP (Good Manufacturing Practice) applies to manufacturing, GDP (Good Distribution Practice) to storage and distribution, and GLP (Good Laboratory Practice) to non-clinical studies. All three serve product quality and patient safety at different stages of the product lifecycle.
How do you help prepare for a regulatory inspection?
We start with a gap analysis of the existing system, identify deficiencies, then conduct self-inspection and a mock inspection. We develop corrective actions for the identified deviations so the system is prepared by the day of inspection.
What should be done in case of an OGYÉI or FDA deviation?
We support root cause analysis, the development of corrective and preventive actions (CAPA), and the compilation of the response to the authority so that the deviation can be closed substantively and on time.
Is it worthwhile for a small company to build a quality assurance system?
Yes. We tailor the system to the organization's size and risks, so it does not create unnecessary administration but provides transparent, more efficient operations and the conditions for market access.
Would you like to strengthen your quality assurance system?
We accompany you from the first audit through preparation for regulatory inspection. Request a tailored proposal for quality assurance consulting!