Pharmaceutical Compliance

Sector Compliance Consultancy Service
& Project work which includes:

• Quality System Implementation and Reviews – auditing
• Service provider approval
• Risk assessments
• Improvement projects and investigational work.
• Closure of CAPAs and non-conformances and investigations
• Consultancy Work
• Route qualification & Transport Validation

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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:




Active Pharmaceutical Ingredients (API),excipient, packaging)

Service Providers

(Transport companies, waste disposal, third party manufacturers / packers, warehouse)

Wholesale (GDP)

Manufacturing (GMP)

Following 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
recommedations 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.

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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