Consultancy Service and Project work carried out, which includes:

Quality system implementation and reviewsauditing, service provider approval, transport validation, risk assessments, improvement projects and investigational work, closure of CAPA’s/non conformance’s /investigations and consultancy work.

Consultancy Service and Project work carried out, which includes:

Compliance FQS

  • Quality System Implementation and Reviewsauditing
  • Service provider approval
  • Transport Validation
  • Risk assessments
  • Improvement projects and investigational work.
  • Closure of CAPAs and non conformances and investigations
  • Consultancy Work


Implementation and review of quality systems

Implement quality systems in line with Good manufacturing practice (GMP), Good distribution practice (GDP), ISO and HACCP (Hazard Analysis critical control Points).


Review systems i.e. auditing or gap analysis.

Auditing can be conducted on the:

  • Systems
  • Processes
  • Suppliers (Active Pharmaceutical Ingredients (API), excipient, packaging)
  • Service Providers (Transport companies, waste disposal, third party manufacturers/packers, warehouse)
  • Wholesale (GDP)
  • Manufacturing (GMP)

Auditing by FQSFollowing audit:

Set up Quality/Technical/Service agreement.

Arrange pre-drawn sample if required.

Assess/review/justify reduced testing programmes.

Gap Analysis can be carried out to determine the gaps in the system with a pre determined standard.  Report provided to identify gaps and recommendations provided to reduce or eliminate the gap.


Service Provider / Supplier Approval

Service provider/supplier review and approval is an essential part of a quality system.  FQS can review and approve service provider/suppliers.

The following forms part of the review process:

  • Assess service provider /supplier – prior to audit review historical data.
  • Risk assess if on site / paper audit is required. (Refer below to auditing)
  • Review / Set up Quality/Technical Agreement.
  • Auditing – Internal, third party (for-cause/prior approval/reduced testing), pre- inspection etc.  Audit and approve service providers and suppliers – audit to various international standards, risk assessment of issues and consult and advise (where required) to facilitate implementation of timely efficient corrective and preventative measures.


 Transport Validation

It is essential to maintain the temperature of products throughout the transportation environment.  It is an area where product can be exposed to extreme conditions, exceeding temperatures that they were exposed to during stability.  The question then arises – Is the product suitable for release to the market?

Transport Validation

 Transport Validation Project includes:

  • Audit and approve transport companies
  • Qualification of reefers, qualification of routes, including risk assessments – matrix approach where possible.
  • Compilation of policies, protocols, risk assessments.
  • Execute mapping where required.
  •  Complete risk assessments on excursions.
  • Review stability policies to ensure they cover possible transport exposures.


Risk Assessments:

Risk assessments are an essential part of any quality system.  In pharmaceuticals there is a variety of stakeholders.

FQS offers an on-site service of:

  • Leading the risk assessment/form part of the multi-disciplinary team.
  • Consultancy on particular risks.
  • Consultancy on the general approach to risk assessments/SOP/Policies.
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Risk Management (QRM) Process – taken from ICH Q9:

Typical Quality Risk Management Process

Sean Dunne, Managing Director
Sean Dunne, Managing Director Pharmapac

Following a thorough and critical compliance assessment carried out by FQS we were provided with practical and compliant recommendations that were tailored to the needs of our specific business. With FQS you can expect an exceptional service and a high level of expert guidance which is delivered in a professional, efficient and personable manner’.

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