Good Manufacturing Practices:
Excellence as a standard
Elexind supports pharmaceutical companies in achieving and maintaining full GMP compliance, with specialized consulting, customized solutions, and a total quality-oriented approach.
FROM COMPLEXITY TO COMPLIANCE.
In the complex and highly regulated landscape of the pharmaceutical industry, compliance with Good Manufacturing Practices (GMP) is not only a legal requirement but an essential condition to ensure that products are safe, effective, and consistently high in quality.
To help companies meet these standards and maintain them over time, Elexind has developed a highly specialized GMP consulting service, designed to address both operational and documentation challenges with precision and promptness.
With a team of qualified professionals constantly trained on regulatory developments, we provide flexible technical support aimed at preventing non-conformities and continuously strengthening the internal quality system.
Review and Update of Quality Procedures
We conduct an in-depth analysis of existing SOPs and assist clients in revising or implementing documentation processes in compliance with GMP requirements.
Development of Work Instructions
We create or adapt clear, user-friendly operational documents that are fully aligned with current regulations and internal policies.
Pre-Audits and Validation Support
We organize internal pre-audits to identify potential issues before official inspections or validation phases, ensuring greater readiness and operational confidence.
Management of Deviations and Investigations
We provide support in analyzing anomalies, identifying root causes, and defining targeted, concrete, and effective corrective and preventive actions (CAPA).
Integration and Alignment of GMP Guidelines with Operator and Environmental Safety
We analyze and update company processes to ensure full GMP compliance while integrating effective measures to protect personnel and the work environment.
Annex 1 Upgrade: Support in Developing the Contamination Control Strategy (CCS), Change Management, and Integration with the Existing Quality System
We assist in defining and implementing a robust CCS in line with Annex 1, supporting change management and harmonization with the existing quality system.
Personnel Training and Procedure Implementation Support
We design targeted training programs focused on GMP procedures and work instructions, tailored to the specific needs of each department. We also provide hands-on field support to ensure consistent and effective application of procedures, making sure they are truly integrated into daily operations.
Choosing Elexind means relying on a competent and trusted partner capable of guiding your organization along a path of continuous improvement and regulatory compliance — helping you build a quality system that is robust, efficient, and sustainable. Together, we can define the GMP pathway best suited to your needs and elevate your organization to new levels of operational excellence.
CHALLENGES INSPIRE US, SOLUTIONS DEFINE US.
Elexind catalog
Explore our Cleanroom product catalog, you will find our solutions for every environment with controlled contamination
Technical assistance
Elexind has always paid attention to the technical assistance service on all marketed or distributed products.
F.A.Q.
Elexind explains almost all cases from cleanroom to health physics equipment
Contact us
ELEXIND S.p.A.
Via A. Erba 35/37 - 20066 Melzo (MI) - Italy
T. +39 02 92.72.151 r.a.
F. +39 02 92.10.33.89