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Pharmaceutical validation and calibration services from SGS – ensure you meet GMP requirements with our dedicated equipment validation, instrument calibration and computer system calibration services.

Pharmaceutical Validation and Calibration

To ensure compliance with the pharmaceutical industry’s strict Good Manufacturing Practices (GMP) you need a trusted partner with a proven track record to help you meet the requirements. Since 1998, we have provided the pharmaceutical industry with specialized validation, calibration, process and quality services in accordance with GMP.

To help you achieve compliance and meet the standards set by worldwide agencies, our broad range of services includes the following:

Equipment validation services:

  • Review and preparation of validation master plans
  • Gap analysis and risk / impact assessments
  • Qualification and validation, including validation plans, design, installation, operational and performance qualifications
  • Support for the implementation of a remediation program 
  • Equipment commissioning (factory and site acceptance tests)

Instrument calibration services:

  • Metrology plan review and preparation
  • Field instrument calibration
  • Reference instrument calibration in our accredited laboratory (LAT n.200) 
  • Calibration of instruments measuring pressure and temperature at our Center LAT n. 200, according to the operating range and uncertainty accredited by ACCREDIA

Information technology compliance and validation:

  • GxP risk assessment and remediation plan management
  • Computer system validation (GAMP v.5)
  • 21 CFR part 11 compliance support and verification
  • Support for IT infrastructure management and IT networks qualification

Process and quality support:

  • Third party and supplier assessment, qualification and auditing
  • Remediation plan management
  • Manufacturing process optimization and validation
  • Risk and gap analysis support
  • Cleaning process development and validation
  • Technology transfer support
  • Regulatory support for the preparation and upgrade of document types, including Common Technical File (CTD), Technical File (TF), and Drug Master File (DMF) types
  • Processes and primary packaging validation
  • Inspections and audit preparation
  • Annual product reviews
  • GMP support (i.e. variations and deviations management)
  • Internal processes analysis to improve the efficiency and efficacy of the company

Safety, quality and environmental (SQE) protection support:

  • Workplace risk assessment reports
  • Emergency plan
  • Single document on the assessment of risk from interference (DUVRI)
  • Risk assessment of exposure to mechanical vibrations
  • Preparation, support and implementation of measures for protection and prevention
  • Noise impact assessment
  • External management for head of the prevention and protection department
  • Fire protection and prevention management
  • Support for drafting the explosion protection report
  • Work supervision
  • Project design and work coordination

Trusted pharmaceutical validation and calibration services from a world leader

As a world-leading provider of services to the life sciences sector, we offer unrivaled expertise in GMP compliance for the pharmaceutical industry. Our experienced team of professionals works closely with your quality assurance departments to ensure you meet the required standards. Plus, our dedicated life science services facility in Livorno, Italy includes:

  • ACCREDIA Center n.200, operating in conformity with UNI CEI EN ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories), which is periodically audited by the certifying body
  • A GMP qualified laboratory for chemical and microbiological tests

To discuss your pharmaceutical validation and calibration requirements, contact us today.