Good Manufacturing Practice (GMP) Audits

GMP Audits: Ensuring Manufacturing Excellence

RxCloud offers comprehensive GMP audits to ensure your manufacturing processes, equipment, and facilities meet industry standards. Our use of pre-written questionnaires and a deviation database ensures thorough, efficient audits across all key areas.

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What Our GMP Audit Covers:

  • Quality Management Systems (QMS): Ensure compliance with industry-specific quality standards.
  • Facility and Equipment Audits: Ensure your production environment meets regulatory and safety requirements.
  • Personnel Qualification: Evaluate staff training and qualifications to ensure proper execution of SOPs.
  • Raw Materials and Components: Audits to confirm the integrity and quality of inputs used in manufacturing.
  • Production Processes: Comprehensive review of production flows and control systems.
  • Packaging and Labelling: Verification of labeling accuracy and compliance with packaging regulations.
  • Laboratory Controls: Evaluate the accuracy and reliability of your lab testing procedures.
  • Documentation and Record Keeping: Ensure full compliance with documentation requirements to avoid regulatory issues.
  • Complaint Handling and Product Recalls: Examine your processes for managing customer complaints and recalling faulty products.
  • Validation and Qualification: Review of process validation to ensure consistent product quality.
  • Regulatory Compliance: Ensuring adherence to local and global regulatory standards.

What is Good Manufacturing Practice (GMP)?

Good Manufacturing Practice (GMP) refers to the systems and processes that make sure products are consistently produced and controlled according to established standards. It’s a set of guidelines that ensures the safety, quality, and efficacy of pharmaceutical and life science products, covering all aspects of production. From raw materials, equipment, and premises to the training of staff. Good Manufacturing Practice (GMP) regulations focus on minimizing risks in production that cannot be fully eliminated by testing the final product.

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Good Manufacturing Practice (GMP)

What is cGMP?

Current Good Manufacturing Practice (cGMP) builds upon GMP by emphasizing the “current” best practices and technologies that should be followed in the industry. It reflects the expectation that manufacturers stay up-to-date with the latest advancements in technology, quality control systems, and scientific standards.

So how do we approach GMP regulations for your business?

At RxCloud, our approach to Good Manufacturing Practice (GMP) regulations is designed to make sure your suppliers meet the highest standards of quality, safety, and compliance. We tailor our services to fit your specific needs, from the initial assessment to ongoing monitoring. 

Our GMP Audit Approach

  • Initial Assessment & Gap Analysis: We start with a thorough pre-assessment of entire supplier processes and systems to identify gaps and areas for improvement, ensuring alignment with GMP guidelines.
  • Customized Compliance Strategy: Based on the pre-assessment, we draft a tailored audit strategy that aligns with global standards and regulations.
  • Process Validation & Qualification: We ensure your production processes consistently meet standards by validating equipment, raw materials, and methods to maintain GMP compliance.
  • Documentation & Record Keeping: We ensure your suppliers are following proper documentation practices, ensuring all records are accurate, up-to-date, and traceable.
  • Facility & Equipment Audits: Our experts review all facilities and equipment for cleanliness, maintenance, and layout to prevent contamination and ensure quality.
  • Ongoing Monitoring & Support We provide post-audit support to help your business stay compliant with evolving GMP regulations.
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Elevate Supplier Standards with RxCloud’s GMP Services

By partnering with RxCloud for our Good Manufacturing Practice (GMP) services, you can be rest assured that your suppliers will operate at the highest level of quality and safety. Our goal is to help you minimize risks, enhance product quality, and maintain compliance with all relevant regulations.

Contact us today!

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Customer Testimonials

Hear from our esteemed customers how our differentiated solutions & services delivered value

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“Our experience with RxCloud for Performance Engineering as a Service has been excellent. With custom executions targeting varied user bases and simulations of real user conditions across different geographies, their team ensured a seamless user experience. They greatly helped reduce our testing cycle times and capital expenditure costs. They have truly delivered outstanding results, driving efficiency in our operations.”

Director of Quality and Operations at a Leading CRO based out of North Carolina, USA

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“Utilizing RxCloud services to streamline our test cycles for Veeva Safety Docs has been transformative. They effectively removed dependency on resources and technical knowledge for test executions and ensured a remarkable 90% reduction in cycle times.”

Chief Information Officer at a Leading Pharmaceutical Company based out of California, USA

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“Our partnership with RxCloud for End-to-End Audit Services has been exceptional. Their team ensured timely audits, global coverage, and a 35% cost reduction with their Fixed Price Managed Services Model.”

Director of Quality and Compliance at a Leading CRO based out of North Carolina, USA