GxPorbit works with firms to Identify
and address any potential compliance concerns or looking for development of quality system or improvements in the existing system.
GMP Audit Service
High quality Audit reports meeting regulatory expectations. Network of highly skilled Auditors. Fair and transparent pricing.
GMP Consultation Service
GxPorbit works with firms to Identify & address any potential compliance concerns or looking for development of quality system or improvements in the existing system.
Training & Certification
Professional trainers and facilitators Customized training programmers. Onsite trainings Virtual trainings.
Who We Are:
- We are a trusted partner in GMP Audit Services, offering comprehensive solutions to ensure your operations meet and exceed regulatory expectations.
- With our network of industry veteran auditors, we offer bespoke solutions designed to ensure your operations not only meet, but exceed regulatory expectations and bringing their wealth of knowledge and experience to every audit.
- We are committed to turning regulatory compliance from a hurdle into an advantage for your business.
- Our GMP Audit Services go beyond checking compliance, offering valuable insights that help enhance product quality, increase operational efficiency, and unlock new market opportunities.
Why Choose Us:
- Our offering extends beyond delivering high-quality audit reports that meet regulatory expectations.
- We promise transparency in pricing, and an experienced network of auditors at your disposal.
- But more than that, we promise a partnership. We are committed to empowering your journey towards achieving unparalleled standards in quality, compliance, and business success.
Our Expertise
- 21 CFR 210 (Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs) and 21 CFR 211 (Current Good Manufacturing Practices for Finished Pharmaceuticals).
- European Commission EudraLex – Volume 4 – Guidelines for Good Manufacturing Practices for Medical Products for Human and Veterinary Use.
- EU (2003/94/EC Part I, II, III)
- PIC/S Guide to Good Manufacturing Practices (GMP) for Medicinal Products
- Health Canada – GMP Guidelines
- ICH Q7 Good Manufacturing Practice guide for Active Pharmaceutical ingredients
- ICH Quality Guidelines.
- ISO 9001:2015 Quality Management Systems
- ISO 15378:2017 Primary packaging materials for medicinal products.
Frequently Asked Questions
What exactly does a GMP audit involve?
A GMP audit involves a thorough review of your manufacturing processes, quality control, and operational practices to ensure they meet Good Manufacturing Practice (GMP) standards.
How can your GMP consultation services benefit my business?
Our GMP consultation services provide tailored advice to help your business meet GMP standards effectively, turning regulatory challenges into opportunities for operational improvement and growth.
Can your GMP consultation services help if we're facing specific compliance issues?
Absolutely. Our consultation services are tailored to address your unique challenges, providing expert advice and practical solutions to help you resolve any compliance issues effectively.
How will your GMP audit services improve my operational efficiency?
Our audit services offer more than just compliance assurance. They provide valuable insights into your processes, identifying areas for improvement that can enhance efficiency and reduce costs.
What makes your services different from other GMP Audit Service providers?
We pride ourselves on delivering high-quality audit reports, offering a network of experienced auditors, and maintaining fair, transparent pricing. More than a service provider, we act as a committed partner in your journey towards excellence.
How do your GMP audit services enhance product quality?
Our audits identify potential areas for improvement in your manufacturing processes. By addressing these areas, you can enhance your product quality, thereby meeting regulatory requirements and satisfying customer expectations.
Are your services cost-effective?
Yes, we believe in offering high-quality services at fair and transparent pricing. We aim to provide you with value that extends beyond compliance, enhancing your operations and business performance.
Can we expect ongoing support after the audit or consultation process?
Yes, we believe in building long-term partnerships. Our team remains available for any follow-up questions or further assistance you may need after the audit or consultation process.
How can I schedule a GMP audit with your team?
Scheduling an audit is simple. Click on the ‘Schedule Now’ button on our website, and our team will get in touch with you to arrange a convenient time.
TESTIMONIALS ---
What Our Clients Say?
“Navigating the complexities of GMP compliance was a major challenge for our company. GXPorbit Audit team was instrumental in turning this hurdle into a business advantage. Their auditors were highly knowledgeable and provided us with valuable insights to enhance our operational efficiency“
“The GMP consultation services provided by GXPorbit team were exactly what we needed. Their tailored advice helped us understand and meet GMP requirements effectively, making the whole process less daunting. We highly recommend their services to any pharmaceutical company looking for reliable GMP guidance“
“The level of post-audit support provided by the GXPorbit Audit team was unparalleled. Their continued guidance and prompt responses to our queries made a significant difference. They don’t just provide a service, they build partnerships. “
GxPorbit is your reliable compliance & Audit Partner.
Office Address
No 182, Zhaohui Road, Hangzhou 310014, China
No 139, Mayuri Nagar, Hyderabad 500049, India
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