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Plant Setup & Upgradation

Building Tomorrow’s Pharmaceutical Facilities Today with our Setup and Upgradation Services

We are fully equipped to manage plant setup, guiding you through every step of the design & building process to ensure seamless and successful project.

We handle fully assembled pharmaceutical and biotech projects, understanding that pharmaceutical plant design is a crucial field and poor design can lead to significant errors. We utilize our expertise in pharmaceutical production plant design, regional building resources, architectural restrictions, and regulatory requirements. Our ability to develop GMP-compliant production facilities for clients ensures successful foreign audits and ensures the success of pharmaceutical production plants.

Conceptualization

The conception stage is crucial for establishing an effective plant setup, which involves setting objectives, conducting feasibility studies, selecting the ideal location, creating basic designs, managing finances, adhering to regulations, and assessing potential risks to ensure immediate production objectives and industry requirements are met.

Facility Plan and Design Layout

We assess and choose optimal sites, create detailed engineering and architectural plans, ensuring safety, scalability, and strategic placement of equipment for future expansions and technology updates, while adhering to all rules.

Total Engineering Support

To ensure the success of the pharmaceutical facility, we offer complete field details, including construction specifications, equipment layouts, utility systems, effective workflow, and safety features, as well as geological, topographical, geotechnical, and hydrological advice from the field experts for solid groundwork.

Procurement Support

Our expert procurement support ensures that your plant setup is equipped with high-quality resources, delivered on time, and within budget, paving the way for efficient and compliant operations. We assist in researching and selecting reliable suppliers, evaluating equipment needs, bidding processes, and securing best deals.

Installation- IQ, OQ, PQ

We offer comprehensive installation and validation services for manufacturing equipment, ensuring compliance with GMP standards. Our services include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to verify proper setup, functional performance, and reliable operation.

Commissioning and Qualification

The equipment, utilities, and facilities must be GMP compliant, and validation is conducted to ensure reproducibility in production, cleaning, analytic methods, and computer systems.The process involves systematic testing and verification of all systems and equipment to ensure their correct installation and functionality.We guarantee equipment and systems are installed to specifications and confirm system operation under various conditions, ensuring consistent real-world results.

Validation

We handle all validation project requirements, including URS, FRS, DQ, SAT, FAT, commissioning documents, IQ, PQ, OQ, PV, and validation report writing.

Vendor Identification and Management

Our services cover vendor identification, contract management, performance monitoring, and regulatory compliance, ensuring high-quality, cost-effective and timely supply chain operations.

Computer System Development & Management

We provides entire computer system development and validation services, including design, installation, operational, and performance qualification, ensuring robust, reliable, and industry-compliant systems.
  • Plant Upgradation

We help you to make an embarking journey to enter regulatory market with our meticulous planning and strategic upgrade.

If your API or formulation plant has already secured approval from the local regulatory body and youaim to enter regulated markets like the USFDA, EMEA, WHO, MHRA, PIC/S, etc., you mayconsider utilizing our Plant Upgradation Service.

  • Our strategies to ease your plant upgradation

Target Regulatory authority

We offer a entire assessment of your facility’s current state, identifying areas of enhancement to meet the stringent criteria of regulatory targets, ensuring a precise scope for targeting specific authorities such as the USFDA, EMEA, WHO, MHRA, and PIC/S

GAP audit of existing plant and its reports

A GAP audit is a crucial step in ensuring compliance with regulatory standards and optimizing operational efficiency in API/Formulation plants. Our process involves a thorough evaluation of current practices and facilities, and provides a report on identifies areas of non-compliance and suggests necessary actions to ensure your facility meets regulatory standards and operates at optimal performance.

Preparation of CAPA plan:

Our CAPA plan preparation service involves a thorough analysis of audit findings, the development of corrective and preventive actions, and the establishment of an implementation strategy with monitoring mechanism for continuous improvement.

GAP identification and timely process

We meticulously identify gaps through stringent assessment and then create a time-bound milestones for the upgradation process.
This structured approach ensures systematic progress toward aligning your operations with regulatory standards and achieving optimal efficiency with defined timelines.

Changes in Layout and design

Our team evaluates current plant layouts, identifies areas for improvement, and implements strategic changes to optimize workflow efficiency, enhance safety measures, and ensure regulatory compliance, ensuring optimal operational needs and regulatory compliance.

SOP’s and Policies Upgradation

Our specialized service involves reviewing existing SOPs, identifying gaps, and developing updated protocols for specific operations. This ensures compliance with evolving regulatory standards and industry best practices, enhances operational efficiency, mitigates risks, and upholds the highest quality and safety standards.

Policies Redesign

Our approach to policy redesign involves a thorough review of existing policies, identification of areas for improvement, and the development of updated ones that reflect best practices and address emerging challenges. This helps organizations strengthen governance, enhance compliance, and foster a culture of continuous improvement.

Training

Our comprehensive programs cover topics like GMP/GCP guidelines, SOPs, regulatory updates, and safety protocols. We customize training modules to meet your organization’s needs, delivering engaging sessions through workshops, webinars, and interactive sessions. Investing in training empowers your team with the necessary knowledge and skills to excel and contribute to your organization’s success.

QMS system establishment/ restructuring as per requirement

We specialize in creating or restructuring customized QMS for your organization, ensuring regulatory compliance and operational excellence through needs assessment, system design, implementation, staff training, and continuous monitoring.

Internal Audit System development

We specialize in creating customized Internal Audit Systems for your organization, ensuring complete coverage, regulatory compliance, and continuous improvement, thereby strengthening governance and risk management practices.

  • Why Choose Zenovel ?
  • Timely Follow
We work on task immediately and complete it within timelines
  • In hands of expert
Our experts team are well qualified with the field experts and with years of experience
  • Wholesome knowledge
With years of experience, we are updated with all relevant policies and SOPs.
  • Support
Our team support you in every aspect of your process, and ensure you to assist in any loopholes

Blogs and news

Our Latest Article

Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)

Abstract For the past few years, regulatory bodies, industry advocacy groups, and private companies have been tackling the concept of incorporating risk into the design of clinical trials and customizing monitoring strategies based on those risks to achieve higher-quality outcomes. Regulatory guidance like ICH and FDA encourages sponsors to adopt

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Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Introduction In the realm of inhalation studies, achieving consistent compliance and accurate results is a considerable challenge due to the complexities associated with trial conduct.Zenovel, a third-party monitoring company, boasts extensive experience in monitoring inhalation studies. This article sheds light on Zenovel’s recent involvement in the monitoring of three studies

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GxP Quality Guidelines and Regulations: Frequently Asked Questions

Noncompliance with GxP regulations can result in significant repercussions for sponsors and their collaborators. This could include financial penalties and legal actions. If a sponsor fails to adhere to federal GxP regulations to a significant extent, endangering public safety, they may receive a warning letter from regulatory authorities. In response,

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Ensuring Data Integrity: Best Practices and Considerations

Introduction There are multiple definitions of data integrity, yet the essence is the same. Data integrity is the overall accuracy, completeness, and consistency of data.Data integrity is the maintenance of, and the assurance of the accuracy and consistency of data over its entire life-cycle and is a critical aspect to

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Enhancing Clinical Studies with GCP Audit and Monitoring

Understanding GCP Audit and Monitoring GCP guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide a framework to ensure the ethical conduct, safety, and quality of clinical trials. Audit and monitoring are essential components of GCP compliance and play a

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Challenges and Expert Monitoring in Liposomal Amphotericin-B BE Studies

Introduction Liposomal Amphotericin-B is a critical antifungal medication that requires careful attention during Bioequivalence (BE) studies. These studies aim to demonstrate the similarity of a generic liposomal Amphotericin B formulation to the reference drug in terms of pharmacokinetics.Zenovel, with its extensive experience in monitoring Amphotericin B studies, can play a

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Contact Us

  • India
  • Australia
  • 9, Blaxland Avenue,
    Cranbourne North,
    Victoria-3977, Australia
  • Brazil 
  • Rua Praia do Tubarão, Quadra C,Loteamento Eco Vilas, Lote 13 – Vilas do Atlântico 42708-730 Lauro de Freitas, Bahia, Brazil
  • Brazil 
  • R. Álvaro Müler, 932 - Vila Angelino Rossi, Campinas-SP,13023-240, Sao Paulo, Brazil.
  • USA
  • 911 Hwy 6 Hitchcock,
    Texas, 77563, USA
  • Canada
  • 215 Moorlands Crescent,
    Kitchener, Ontario N2P 0C3
  • China
  • Zhenjiang Tech Park, Shanghai China
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