360º Pharma Integrity

A unified framework to ensure quality,
integrity, and regulatory excellence.

360° Pharma Integrity

A unified framework to ensure quality, integrity, and regulatory excellence.

What does our 360º Pharma Integrity service offer?

360° Pharma Integrity is a comprehensive and structured approach designed to sustainably strengthen product quality, process integrity, and regulatory preparedness for portfolios and OTC products in highly demanding and regulated environments.

It integrates, under an expert and results-oriented vision, the critical pillars that regulatory bodies systematically evaluate during audits, inspections, and approval processes, allowing organizations to transition from reactive compliance management to a preventive, robust, and reliable model.

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Methodology

Based on global manufacturing best practice methodologies, we cover the following development pillars:

  • Good Manufacturing Practices (GMP)
  • Validations
  • Stability Programs
  • Design, Construction, and Installation (GMP Infrastructure)
  • Risk Assessments (Quality Risk Management)
  • Quality Systems
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Good Manufacturing Practices (GMP)

Standardization and strengthening of operations under a process control and documentary discipline approach, aligned with applicable regulatory expectations. We implement and optimize SOPs, good documentation practices and data integrity, in-process controls, material handling and segregation to prevent mix-ups and cross-contamination, enabling end-to-end traceability, consistent batch execution, and solid evidence for audits and inspections.

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Validations

Design, execution, and sustainment of risk-based and lifecycle validation strategies (processes, cleaning, analytical methods, and computerized systems), with clear technical acceptance criteria and traceability of requirements to evidence. We ensure that processes, equipment, and systems operate in a state of control, with reproducible performance and demonstrable capability, integrating continuous verification, periodic review, and change management to protect the validated state against operational adjustments, scaling, and transfers.

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Stability Programmes

Design, execution, and evaluation of stability programs under ICH guidelines, supported by indicating methods and scientific degradation criteria.
We define protocols (climatic zones, accelerated/intermediate/long-term conditions), sampling strategies, and trend analysis that support shelf life, storage conditions, packaging, and retest periods, generating defensible regulatory decisions and facilitating approvals, post-registration changes, and continuity of supply.

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Design, Construction, and Installation (GMP Infrastructure)

Design and execution of GMP-compliant infrastructure projects, from user requirement specifications (URS) and conceptual/detailed design, to commissioning, qualification, and operational handover.
We optimize layouts, personnel/material flows, area classification, HVAC, critical utilities, and maintainability criteria to enhance compliance capabilities, reduce contamination risks, and enable scalability. Beyond "compliance," we design for efficient, resilient operations and inspection readiness.

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Risk Assessments (Quality Risk Management)

Systematic application of Quality Risk Management (QRM) to identify, analyze, prioritize, and control vulnerabilities that may impact quality, patient/consumer safety, and compliance.

We use methodologies such as
FMEA, cause-and-effect analysis, and criticality matrices to define risk-proportionate controls, strengthen decision-making, and anticipate deviations and findings before they materialize.

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Quality Systems

Design, maturation, and remediation of integrated, performance- and governance-oriented Pharmaceutical Quality Systems (PQS). We strengthen core processes: deviation and investigation management, CAPA, change control, document management, supplier control, management review, and periodic product/process quality review.

The result is an auditable system, consistent across areas, capable of demonstrating control, detecting early trends, and sustaining continuous improvement with data-driven decisions.

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