Zydus Hospira Oncology

Client Name

Zydus Hospira Oncology Pvt. Ltd.

Organization Size

1,001-5,000

Solution

EHS Management Software

Challenge

  • Pen and paper approach

  • No proactive EHS assessment

  • Ensuring adherence to the varying EHS regulatory requirements across different countries

  • Manual record-keeping for audits

Zydus Hospira oncology used to follow a traditional pen-and-paper approach in their EHS domain.

Pharmaceutical manufacturing plants are specialized manufacturing environments. Based on the products, formulations, or APls manufactured, the safety net of compliance and regulatory framework adapts and establishes the conformities for EHS ground rules. The other aspect of EHS compliance is conformity to specific country standards or norms and Good Manufacturing Practices (GMP). These are absolute requirements that allow the products to be sold in the markets of different countries with the regulatory authorities assured of their quality, safety, and risks.

The management systems standards, as stipulated by stakeholders’ global EHS management framework, recommended regulatory compliance, risk assessment, communication, self-audit, and senior leadership engagement as part of EHS management. These were among the few key elements they wished would form the basis of a proactive feedback-based EHS management system.

Thus, we suggested a SAFE path to compliance.

Solution

  • SAFE software

  • Data analytics enable a proactive approach.

  • Ensuring that permits move along a prescribed process.

  • Ensuring compliance through a standardized approach.

Through our initial interactions, followed by a subsequent TECH EHS on-site demonstration, Zydus Hospira oncology could already identify and visualize a synergy—the SAFE software was meeting a large majority of their needs to a greater degree.

For the implementation of SAFE, EHS management software, we initiated the pilot phase, during which the plant EHS team was trained on the knowledge and use of the software modules.

As part of the next phase in implementation, we trained and educated the technical team, the end-users within the EHS niche, on the use of SAFE and its different modules.

The total time spent on both these activities was limited to 5 site visits. The technical team’s training was wrapped up within 2 days.

The modules implemented were:

  • Permit to work (300 requests are raised each month.)

  • Risk assessments

  • Management of change

  • Audit

  • EHS program review.

  • Incident reporting and management

  • Register of regulations

  • Safety observation

  • Manpower module

  • Medical checkup

Zydus Hospira finally implemented the modules in a controlled manner, using collaborative thinking with TECH EHS to help them understand and fine-tune the implementation process or, simply put, to ease its users into a new system.

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Outcome

TECH EHS’s software-based approach helps our client achieve twin goals: compliance and EHS information management.

Gemba scorecard, Ishikawa diagram (Fishbone analysis), and why analysis (based on Six Sigma principles) is a standard part of our SAFE software. This means that the numbers generated within the SAFE environment can be used for further analyses by our client without using any other tool.

Our SAFE software supports the transitive relationships, different EHS processes share in pharmaceutical manufacturing, making EHS operations seamless for our client.

Benefits

Compliance with Regulatory Standards
Compliance with Regulatory Standards
Risk Assessment and Management
Risk Assessment and Management
Self Audit
Self-Audit
Continuous Improvement
Continuous Improvement