GMP Auditing Services
GxPorbit is your reliable compliance and Audit Partner. At GxPorbit, we offer GMP audit services to help pharmaceutical and medical device companies comply with the regulatory requirements and ensure the quality and safety of their products.
The GMP audits are conducted by qualified and highly experienced consultants having comprehensive knowledge in pharmaceutical and Medical devices sector.
We conduct audits of your suppliers to ensure that they meet quality and regulatory requirements. Our auditors assess their facilities, processes, and systems to identify potential risks and provide recommendations for improvement.
We offer a wide range of audit services, including:
- Audit of Active Pharmaceutical Ingredients (APIs) facilities.
- Audit of Intermediate’s facilities.
- Audit of Finished Dosage manufacturing facilities.
- Audit of Excipients facilities.
- Audit of Packing Materials facilities.
- Audit of Medical devices facilities.
Our Approach
Our audit approach is based on industry best practices and our experience working with a range of pharmaceutical and medical device companies. We use a risk-based approach to identify areas of high-risk and prioritize our recommendations for improvement.
Our audit process typically includes:
Planning: We work with you to understand your specific needs and goals for the audit. We review your documentation and prepare an audit plan.
On-site assessment: Our auditors conduct an on-site assessment of your supplier facilities, processes, and systems. We use a checklist of GMP requirements and standards to guide our assessment.
Reporting: We provide a comprehensive audit report that includes our findings, observations, and recommendations for improvement.
Follow-up: We follow up with your suppliers to ensure that corrective actions have been implemented and to provide ongoing support as needed.
Why Choose GxPorbit:
Choosing the right GMP audit services provider is critical to the success of your compliance program. At our GxPorbit Consultants, we offer:
Experience: Our auditors have extensive experience working with a range of pharmaceutical, biotech, and medical device companies. We understand the regulatory landscape and can provide practical solutions to help you comply with GMP regulations.
Expertise: Our team includes experts in GMP regulations, quality systems, manufacturing processes, and risk management. We use a risk-based approach to identify areas of high-risk and provide recommendations for improvement.
Objectivity: Our auditors are independent and objective. We provide an unbiased assessment of facilities, processes, and systems to identify potential gaps and areas for improvement.
Quality: We are committed to delivering high-quality audit services at competitive price.
Customized solutions: We understand that every client is Unique. Hence, we tailor our GMP audit services to meet your specific needs.
GxPorbit is your reliable compliance and Audit Partner. At GxPorbit, we offer GMP audit services to help pharmaceutical and medical device companies comply with the regulatory requirements and ensure the quality and safety of their products.
The GMP audits are conducted by qualified and highly experienced consultants having comprehensive knowledge in pharmaceutical and Medical devices sector.
We conduct audits of your suppliers to ensure that they meet quality and regulatory requirements. Our auditors assess their facilities, processes, and systems to identify potential risks and provide recommendations for improvement.
We offer a wide range of audit services, including:
- Audit of Active Pharmaceutical Ingredients (APIs) facilities.
- Audit of Intermediate’s facilities.
- Audit of Finished Dosage manufacturing facilities.
- Audit of Excipients facilities.
- Audit of Packing Materials facilities.
- Audit of Medical devices facilities.
Our Approach
Our audit approach is based on industry best practices and our experience working with a range of pharmaceutical and medical device companies. We use a risk-based approach to identify areas of high-risk and prioritize our recommendations for improvement.
Our audit process typically includes:
Planning: We work with you to understand your specific needs and goals for the audit. We review your documentation and prepare an audit plan.
On-site assessment: Our auditors conduct an on-site assessment of your supplier facilities, processes, and systems. We use a checklist of GMP requirements and standards to guide our assessment.
Reporting: We provide a comprehensive audit report that includes our findings, observations, and recommendations for improvement.
Follow-up: We follow up with your suppliers to ensure that corrective actions have been implemented and to provide ongoing support as needed.
Why Choose GxPorbit:
Choosing the right GMP audit services provider is critical to the success of your compliance program. At our GxPorbit Consultants, we offer:
Experience: Our auditors have extensive experience working with a range of pharmaceutical, biotech, and medical device companies. We understand the regulatory landscape and can provide practical solutions to help you comply with GMP regulations.
Expertise: Our team includes experts in GMP regulations, quality systems, manufacturing processes, and risk management. We use a risk-based approach to identify areas of high-risk and provide recommendations for improvement.
Objectivity: Our auditors are independent and objective. We provide an unbiased assessment of facilities, processes, and systems to identify potential gaps and areas for improvement.
Quality: We are committed to delivering high-quality audit services at competitive price.
Customized solutions: We understand that every client is Unique. Hence, we tailor our GMP audit services to meet your specific needs.
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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