Commissioning, Qualification and Validation.

GxPFONT follows an integrated lifecycle approach to commissioning, qualification, and validation, with scientifically sound and risk based program design in all areas of pharmaceutical and biotech operations. Our strengths lie in Process Validation, Cleaning validation, Sterilization, Media fill, Smoke Study, CSV, Analytical Method validation, HVAC qualifications etc.
Commissioning, Qualification and Validation, when planned and performed correctly in an integrated manner, it ensures operational efficiency, effectiveness and compliance.

Project Management

At GxPFONT we start with the end-result in mind in alignment with our customer’s overall goals. We engage all our stakeholders starting from the design/engineering phase, capturing and sharing all critical design information universally, before specifications are developed. This information is carried through the entire project lifecycle, using project management tools. We place the entire team on a single platform, which minimizes the chances of errors and reworks. This also helps in delivering projects on time.

Quality management System development

Our experts at GxPFONT, are highly competent in assessing the QMS of client organizations and facilities for compliance with current regulatory expectations. We assess your processes, not to find a fault but to provide actionable feedback and to execute comprehensive, targeted remediation plans. This helps in avoiding future regulatory citations.
We also assist in regulatory filing requirements, deficiency letter response and in addressing complex technical and regulatory challenges.

Audit and Compliance

With a vast diversified experience and expertise of our team at GxPFONT, we champion in preventing and resolving any compliance related issues. Through our integrated approach and with help of our technical experts, we provide specific, actionable recommendations to our clients. We realize that Auditing is not a fault-finding exercise, hence we work with the shop floor team very closely to identify the gaps and resolve them from its roots.

Our team of experts from around the globe are well equipped to provide remote auditing services and train the clients resources on the same.

Risk Management

Quality risk management solutions begin and endure as risk-based thinking. As a pharmaceutical or biologics company, you benefit from a logically sound, forward-looking process development and product manufacturing function that emphasize on an integrated quality risk management program. The ICH Q9 Quality Risk Management guidance is just a starting point. We tell you what next, where to start, which tool is appropriate for you and how to build a sustainable risk based model for all your critical operations. Our team of experts specializes on various risk management tools that can bring enormous results in your operations.

Process Development & Technology Transfer

With a vast experience from reputed pharmaceutical organizations around the world, our team of expert scientists provide specific solutions for process development & technology transfer of all types of pharmaceutical dosage forms. We not only help in remediation of your week point products, but also build the efficiency and robustness around the processes. We also support in regulatory filing of any new products or change updates.

Environment Health & Safety

We help organizations by educating and promoting a culture of Environment Health & Safety to root and grow a self-sustained environment. Over time, this helps in building a virtually accident/incident free organization. We believe, creating sustainable value for all stakeholders is a key component to the long- term success of any project. Our Services include, but not limited to; EHS Audits, HAZOP Study, Risk Assessment, Fire Load Calculation, Fire Risk Assessment, Fire Safety Audit, Onsite Emergency Plan, Safety Report, Due Diligence, Hazard Area Classification, Fire Hydrant Design, Legal requirements assessment, HARA, HIRA & PSM.

We also offer ESG rating support to our clients.

Technical Trainings

Our learning solutions deliver effective and efficient methods for sharing, sustaining, and expanding knowledge, skills, and expertise. We always start with understanding the learning needs of the targeted group and customise our trainings based on exact need. Our technical learning solutions include; Basic and advanced GMP trainings, Risk evaluation methodologies and quality risk management (QRM) tools, Root-cause investigations and corrective/preventive actions, Aseptic practices, Human error reduction, Data Integrity, Environment Health and Safety trainings and Preparing for regulatory inspections and remote inspections.

Supervisory Skill Development

A major driver of quality, safety and productivity at shop floor depends upon effectiveness of supervisors in any organization. Our learning solutions include practical assessment of each individual supervisors on their effectiveness and building their skills based on identified weak areas and monitoring their progress on a scientifically designed tool.
We also offer programs on lab error reduction for analyst of QC labs.

Leadership Development

As the Pharmaceutical industry is manoeuvring through choppy waters, it has become more than essential to have right leadership on board. Our global leadership development solutions accelerate business results through leadership building by targeting specific areas that serve as levers of change in the organization. These solutions include: Collaborative leadership, Aligning with Vision and Mission of the Organization, Quality culture change, Executive coaching solutions and assessment.

Immersive Learning for Cleanroom Employees 

INOVR is our virtual reality based innovative training platform, which delivers training modules to help controlling human errors and associated regulatory citations in pharmaceutical manufacturing and QC laboratories by enhancing training effectiveness and learning retention. It allows you to train and practice till perfection without compromising your critical area. The modules are available on, but not limited to;

• Aseptic Processing
• Cleaning & Disinfections
• Basic Microbiology
• OSD manufacturing
• Plant Engineering
• API manufacturing

Note: All our Virtual Reality based training modules are designed under the guidance of highly experienced Pharma professionals and passed through stringent quality checks.

Please visit the INOVR website to learn more..