PTM’s Quality & GMP Support area offers a comprehensive, integrated support for managing quality systems in pharmaceutical companies.
The purpose is to build solid, traceable and compliant systems that ensure reliable processes and long-term sustainability.
Our activities range from the managing of Changes, Deviations, and CAPAs to Quality Agreements and proactive planning of supply chain improvements. PTM also conducts audits of suppliers and third parties in API, Pharma, and Laboratory contexts, ensuring full compliance with regulatory requirements and internal standards.
With consolidated experience, we support companies in remediation and improvement projects, as well as in preparing for inspections by regulators or clients. Our aim is to create a robust, coherent and sustainable quality system that goes beyond mere compliance.
Integrated, risk-based quality approach
PTM’s model is based on a risk-based approach that integrates risk management into the planning and daily activities of the Quality area.
Over time, this vision has led to a true Integrated Quality Risk Management, improving efficiency and traceability of information.
This approach allows to:
Optimize time, costs and resources for quality activities
Improve management and sharing of product and process information
Strengthen decision-making through structured and documentable risk assessments
Targeted Risk Assessment services
PTM applies Risk Assessment activities to key areas of concern in the pharmaceutical sector, including:
Elemental Impurities
Reagents and solvents
Nitrosamine
Residual solvents
Extractables & Leachables
All analyses are conducted using validated methodologies and tools that ensure traceability, transparency and replicability of decisions.
Thus, risk assessment becomes an integral part of the quality strategy, not an isolated exercise.
Data Integrity and Computer System Validation
An increasingly strategic area of our support is Data Integrity and Computer System Validation (CSV), crucial for ensuring data reliability throughout the product lifecycle.
PTM activities cover:
Production and automation systems
Analytical and control instrumentation
Data management and monitoring systems
These interventions ensure information is accurate, consistent and secure, contributing to overall process quality and the credibility of the results during audits or inspections.
From setting up the quality system to its continuous evolution, PTM supports companies with a methodical, competent and attentive approach.
Our purpose is to make quality measurable, widespread and sustainable, integrating operational and strategic perspectives and equipping organizations with tools to manage complexity consciously.
Via Roma, 24 – 42049 S.Ilario d’Enza (RE) Italy