GMP/GxP Consulting

Activities in the healthcare and pharmaceutical industries are strictly regulated by numerous guidelines and legislative acts, particularly the Good Manufacturing Practice (GMP) guidelines for pharmaceutical production and related practices for other areas collectively referred to as GxP. Industry facilities must be designed, constructed, commissioned, and operated in compliance with GMP/GxP standards, which involves complex process equipment, cleanroom systems, process utilities, monitoring systems, and advanced quality management systems. This, in turn, requires a high level of expertise and specialized knowledge from professionals involved in the implementation of such projects. Companies in the sector, as well as those involved in general construction and industrial design, typically lack personnel with these competencies and can only obtain such support through consulting services from external experts, engaged at the earliest stages of project development.

Tarqvara Pharma Technologies offers a full range of consulting services in GMP/GxP, such as:

Review of design solutions for compliance with GMP and GDP requirements
Expert support in decision-making regarding production site location, technologies, equipment, and products
Optimization of layout solutions from the perspective of GMP/GDP, process requirements, personnel safety, and applicable regulations
Resolving requirement conflicts when applying occupational safety, hygiene, and GMP requirements in high-risk environments, such as the production of antibiotics, hormones, highly potent drugs (e.g. cytostatics), as well as fire and explosion hazards, and areas with microbiological risks
Implementation of modern containment technologies (isolators)

GMP Certification vs GMP Consulting

It is important to clearly distinguish between GMP Certification (obtaining a GMP certificate or a manufacturer’s authorization for medicinal products) and GMP Consulting services, such as preparing a pharmaceutical facility for inspections, conducting GMP audits, and providing recommendations on bringing operations into compliance with GMP standards.

On the internet, some private companies offer GMP Certification services, and search results may sometimes show phrases like "GMP Certification in Estonia: Tallinn, Tartu, Pärnu..." etc. It is crucial to understand that this is a scam or, at the very least, click-bait. The fact is that no private company has the authority to issue an official GMP Certificate or a pharmaceutical manufacturer’s authorization. To obtain these documents, you must contact local health authorities and successfully pass a GMP inspection, which is conducted solely by government inspectors. While a private consulting firm can issue a nicely formatted document labeled "GMP Certificate", such a document holds no legal validity.

The specialists at Tarqvara Pharma Technologies have extensive experience providing consulting services in Good Practices (GxP) relevant to the healthcare and pharmaceutical sectors, including GMP (pharmaceutical Good Manufacturing Practice), GDP (Good Distribution Practice for medical products), GAMP/RDI (Good Automated Manufacturing Practice / Records and Data Integrity), GLP (Good Laboratory Practice), as well as related practices and standards such as Good Documentation Practice (GDocP), ISO 9001 Quality Management Systems, and requirements for industrial, microbiological, fire safety, environmental protection, and occupational safety in compliance with international, European, and national regulatory requirements and standards.