Confidence Beyond Compliance

The objectives and scope for Quality Management across the Product Lifecycle are broadening with current evolving legislation and best practice standards, as evidenced by ICH Q8, Q9, Q10, Q11 and ICH Q12 (concept paper) . This demands the design and implementation of Quality Management Systems, and supporting procedures for Quality Management of all systems, at the early stages of product development, through commercialisation and withdrawal, and more specifically, for the Quality Management of Systems for;

  • Design, commissioning and qualification of the new facility in compliance with GEP
  • Pre-clinical and clinical supply manufacturing in compliance with GMP
  • Pre-clinical trials in compliance with GLP
  • Clinical trials in compliance with GCP
  • Qualification and Validation in compliance with GMP
  • Manufacturing, testing and release in compliance with GMP
  • QA and QC in compliance with GMP
  • Warehousing, distribution and transportation, in compliance with GDP
  • Pharmacovigilance and Market Surveillance, in compliance with GVP

PharmaLex’s team of expert GxP consultants has direct expertise in designing and implementing Pharmaceutical Quality Systems, including SOP development, in compliance with legislation, regulations and best practice, including;

  • Mapping the scope of Quality Management responsibilities and activities across the:
    • New Product Design, Development and Introduction process
    • New Facility Design, Construction, Installation, Commissioning and Qualification, Validation and Licensing process
    • Supply Chain, from API and material sourcing to finished product manufacture, testing, release for shipment and distribution to the customer
  • Scoping and drafting the Quality Manual as per ICH Q10, describing your commitment to Quality and Compliance and the implementation of an effective Pharmaceutical Quality System (PQS) that is designed to achieve your stated Quality Objectives, and encompassing processes for system Quality Management, for example, the system for material handling, the equipment calibration system or the system for release for shipment and distribution of the finished product.
  • Designing tailored Quality Management Systems, incorporating principles for Quality Risk Management and Data Integrity, to ensure an integrated PQS and compliance with regulatory requirements and best practice standards
  • Documenting and assisting with the set up and implementation of Quality Management and supporting systems at your site
  • Identifying gaps in your Quality Management Systems and supporting systems that could impact on product quality or regulatory compliance, which could present potential quality or compliance risks for your business
  • Quality Management System remediation in order to meet your changing needs and the demands of evolving regulatory requirements and best practice standards, including SOP development.

PharmaLex’s team of consultants, which includes a number of former EU regulators, are experts in developing and implementing robust systems for Quality Management to meet these requirements for quality and compliance across the Product Lifecycle.