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Quality Assurance SolutionsQuality Assurance Solutions

Quality matters.

Practical solutions for robust pharmaceutical quality systems.

From day-to-day responsibilities to complex projects and critical situations, we help you assess the challenge, define the next steps and put solutions into practice.

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Quality expertise for your EU and non-EU projects.

  • Independent
  • Experienced
  • Accountable
  • Practical
  • Reliable

Our services

Practical expertise. Solutions that work.

Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) support built around your operations, responsibilities and priorities, in the European Union (EU) and beyond.

Good Distribution Practice

Responsible Person services

Practical oversight of pharmaceutical distribution.

RP services to support GDP-compliant distribution. We help maintain an effective quality management system (QMS) and standard operating procedures (SOPs), oversee outsourced activities and address quality risks across storage, transport and the pharmaceutical supply chain.

  • RP services and ongoing GDP oversight
  • Distribution QMS and SOPs
  • Supplier, customer and service provider qualification
  • Storage, transport and cold-chain quality oversight
  • GDP and RP responsibility training for your team

Good Manufacturing Practice

Qualified Person services

Experienced QP oversight and batch certification.

QP services, including batch certification and assessment of compliance with GMP and the marketing authorisation. We work with your quality, manufacturing and regulatory teams to review the evidence and resolve outstanding quality matters.

  • QP batch certification and cover
  • Batch documentation review
  • Assessment of deviations, changes and quality risks
  • Oversight of outsourced manufacturing and testing
  • Quality agreement review and QP arrangements

Independent assessment

GMP and GDP audits

Understand your compliance status. Act on the findings.

Independent audits and gap assessments tailored to your operations. We identify gaps, explain the evidence behind findings and help define proportionate corrective actions.

  • Supplier qualification and requalification audits
  • Internal audits and compliance gap assessments
  • QP audits and manufacturing oversight
  • Audit reports, CAPA review and follow-up
  • Internal auditor training and practical audit preparation

Continuity and recovery

Interim QA and Crisis Management

Expert support when decisive action matters most.

Interim quality leadership and operational support during staffing gaps, transitions and critical quality situations. We establish priorities, coordinate remediation and maintain oversight through recovery and handover.

  • Interim QA management and operational support
  • Risk assessments and implementation of risk mitigation measures
  • Critical issue assessment, immediate action and recovery planning
  • Transfer and handover of quality responsibilities
  • Development and implementation of business continuity plans (BCPs)

European market

EU GMP inspection support

Walk into your next inspection with confidence.

Support for manufacturers supplying, or planning to supply, the European market. We help manufacturers obtain GMP certification from the relevant health authority through readiness assessment, inspection coordination and follow-up. We assess GMP status, authorisation plans and QP arrangements, clarify inspection prerequisites and help prepare sites, documentation and teams.

  • Initial GMP and regulatory pathway assessment
  • Inspection planning and authority coordination
  • Site readiness, gap assessments and preparation
  • Inspection findings, CAPA responses and follow-up
  • Support through to GMP certification by the relevant health authority
  • Inspection readiness training and practical team coaching

Independent audits support readiness and qualification. Official inspections, scheduling and GMP certification remain the responsibility of competent authorities.

The expertise behind QA Solutions

Practical solutions. Personal accountability.

QA Solutions was founded to bring practical solutions to pharmaceutical quality challenges. We combine independent judgement with hands-on involvement, turning complex requirements into clear responsibilities and workable actions.

We collaborate with independent professionals across the EU, bringing together the expertise and capacity each project requires.

QP
GMP and batch certification
RP
GDP and distribution quality
Audits
Independent GMP and GDP assessments
QA
Quality systems, operational support and training

Peter Durista, DVM

Founder and Managing Director

With 15 years of GxP experience across pharmaceutical manufacturing, biotechnology and distribution, Peter founded QA Solutions to help clients build robust quality systems and turn regulatory requirements into practical solutions. His expertise includes QP batch certification, market release and quality oversight for vaccines, other biological medicines and diverse dosage forms.

He supports established companies and greenfield start-ups, combining an understanding of business needs with sound quality judgement, a proactive mindset and a structured, hands-on approach to problem-solving.

Based in the Czech Republic, Peter works with clients in EU and non-EU countries through remote, on-site and hybrid collaboration.

How we work

Understand your needs. Deliver practical solutions.

  1. Understand your needs

    We review your operations, responsibilities and priorities to identify where support will make a difference.

  2. Agree the approach

    A clear scope, defined responsibilities and realistic timelines. You know what we will deliver and how we will work together.

  3. Deliver and follow through

    Hands-on support, clear communication and practical actions, with follow-up through completion and handover.

Who we help

Your operations. The right quality support.

Based in the Czech Republic. Supporting clients across Europe.

  • Manufacturers and importers

    QP services, batch certification support, GMP audits and operational QA expertise.

  • Biotechnology companies and CDMOs

    Quality support for biological products, outsourced manufacturing and cross-functional collaboration.

  • Wholesale distributors and logistics providers

    RP services, GDP systems and oversight of storage, transport and outsourced activities.

  • Marketing authorisation holders

    Quality oversight of manufacturing partners, quality agreements and product-related quality matters.

  • Manufacturers preparing for Europe

    EU GMP readiness, independent audits and inspection support for sites outside the EU.

  • Companies facing change or a crisis

    Interim leadership and practical support during staffing gaps, urgent remediation and organisational transitions.

Quality matters. Our role is to help clients make sound quality decisions and turn them into practical, effective solutions.

Peter Durista, DVMFounder and Managing Director

Join our network.

Are you an independent GMP, GDP or quality assurance professional? We welcome opportunities to collaborate with experienced specialists across the EU.

Explore collaboration

Let's talk

Your quality challenge. Let's find the solution.

Tell us whether you need QP or RP services, an independent audit, EU GMP inspection support, interim QA leadership or help managing a critical quality situation.

info@qasol.eu

QA sol. s.r.o.Czech Republic

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Quality Assurance SolutionsQuality Assurance Solutions

QP and RP services, GMP and GDP audits, Interim QA and Crisis Management

EU GMP inspection support

QA sol. s.r.o., Czech Republic