The QA service provided by Telstar may be performed in-company by GMP Consultants with experience in national and international projects:

  • Product Quality Review (PQRs)
  • Standard Operating Procedures (SOPs)
  • User Requirement Specifications (URSs)
  • Process validation
  • Cleaning validation, clean holding times, dirty holding times
  • Deviation management with root cause analysis and CAPA management
  • Personalized theoretical and practical training
  • Internal audits, GAP analysis and implementation of quality systems according to GMP (EU, FDA) / GDP / ISO 13485 (Medical Devices)
  • Preparation and support on FDA Pre – Approval Inspections (PAI)
  • Data integrity

An essential element of QA services is internal quality auditing, where subject matter experts of Telstar support the compliance performance of companies by audits, gap analysis of the existing quality system and implementation of corrective and preventive actions. The aim is to successfully pass GMP (EU, FDA) / GDP / ISO 13485 (Medical Devices) inspections.

Quality risk management is another essential aspect of any service provided by Telstar. Decisions based on risk assessment according to ICH Q9 Guidelines are integrated across the whole product lifecycle.

Some examples of risk assessment and risk-based decisions offered to the customer

  • Definition of critical and non-critical quality attributes and process parameters
  • Elemental impurities (ICH Q3D)
  • Correct location of sampling points of clean rooms
  • Justification of an environmental monitoring plan
  • Internal or external quality auditing programs based on risks
  • Supplier qualification
  • Definition of critical instruments
  • Change control management (new ICH Q12 Guideline)
  • Validation scope or frequency, justified at the Validation Master Plan

Telstar Value Services

We work alongside our customers in close partnership, supporting them throughout the full life cycle of their plant and equipment to ensure lasting business success.

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