GMP Consultation Services
At GxPorbit, we provide a wide range of consultancy services designed to help pharmaceutical, biotechnology, and medical device companies comply with Good Manufacturing Practice (GMP) regulations. Our team of experienced consultants has extensive knowledge and expertise in GMP and can help your organization implement and maintain GMP standards.
Our Key GMP consultancy services include:
GMP Remediation:
If your organization has received a warning letter or a citation for GMP non-compliance, we can help. Our GMP remediation services include a comprehensive review of your organization’s processes and systems, identification of areas of non-compliance, and development of a remediation plan.
Regulatory Filing:
We offer regulatory filing services to help your organization prepare and submit regulatory filings for GMP-related activities, including new product approvals, product variations, and license renewals.
Our consultants will work with you to ensure that regulatory filings are accurate, complete, and submitted on time. We will also provide guidance on regulatory requirements and assist you in addressing any regulatory issues that may arise.
Gap Assessment (Practices and Regulatory Expectations) Services:
We offer gap assessment services to help your organization identify gaps between current practices and regulatory expectations. Our consultants will work with you to assess your current practices and identify any gaps in compliance with regulatory requirements.
We will then provide recommendations for improvement and assist you in implementing solutions that meet regulatory requirements and are tailored to the needs of your organization.
Computerized Systems Gap Assessment:
We offer computerized systems gap assessment services to help your organization ensure that computerized systems used in GMP operations meet regulatory requirements.
Our consultants will work with you to assess your computerized systems and identify any gaps in compliance. We will then provide recommendations for improvement and assist you in implementing solutions that meet regulatory requirements.
Mock Inspection Services:
We offer mock inspection services to help your organization prepare for regulatory inspections and identify areas of non-compliance. Our consultants will conduct a simulated inspection of your facility, systems, and processes to identify any gaps in compliance.
We will then provide recommendations for improvement and assist you in implementing solutions that meet regulatory requirements and are tailored to the needs of your organization.
For Cause/Root Cause Inspection Services:
We offer for cause and root cause inspection services to help your organization address issues identified by regulatory agencies or internal audits. Our consultants will work with you to identify the root cause of the issue and develop a corrective action plan that meets regulatory requirements we will also assist you in implementing the corrective action plan.
GMP Compliance Assessments:
Our GMP compliance assessment service is designed to assess your organization’s compliance with GMP regulations. Our team will conduct a comprehensive review of your organization’s facilities, processes, and systems to identify areas of non-compliance and provide recommendations for improvement.
GMP Quality Systems:
We can help your organization develop and implement GMP quality systems that meet regulatory requirements. Our consultants will work with you to design a quality system that is tailored to the needs of your organization and provide guidance on implementation and maintenance.
GMP Training:
We offer GMP training services to help your organization meet GMP training requirements. Our training programs are tailored to meet the specific needs of your organization and can be delivered on-site or online.
Our training covers topics such as GMP basics, GMP regulations, GMP documentation, Cleaning validation principles, Process Validation, Elemental Impurities (ICH Q3D), Nitrosamine Impurities Risk Assessment, Effective investigation of Non-conformances, Basics of Computer System Validation (Annex 11/Part 11 BasicPrinciples and GAMP 5 requirements) and Principles of validation and qualification Etc.,
GMP Documentation:
We can help your organization develop and maintain GMP documentation, including Standard Operating Procedures (SOPs), batch records, and other GMP-related documentation. Our consultants will work with you to develop documentation that meets regulatory requirements and is tailored to the needs of your organization.
GMP Gap Analysis:
We offer GMP gap analysis services to help your organization identify gaps in your current GMP compliance status. Our consultants will conduct a thorough review of your organization’s facilities, processes, and systems to identify areas of non-compliance and provide recommendations for improvement.
GMP Supplier Audits:
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 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.
GMP Data Integrity:
We offer GMP data integrity services to help your organization ensure the accuracy, completeness, and consistency of GMP-related data. Our consultants will work with you to develop and implement data integrity policies and procedures that meet regulatory requirements.
GMP Quality Management System:
We offer GMP quality management system services to help your organization establish and maintain a quality management system that meets regulatory requirements. Our consultants will work with you to develop and implement a quality management system that is tailored to the needs of your organization.
Validation and Qualification Support Services:
We offer validation and qualification support services to help your organization ensure that equipment, processes, and systems are qualified and validated in accordance with regulatory requirements.
Our consultants will work with you to develop and implement validation and qualification protocols, execute validation and qualification activities, and prepare validation reports.
We will also provide guidance on regulatory requirements and assist you in addressing any validation and qualification issues that may arise.
If you are looking for reliable and experienced GMP consultancy services, look no further than GxPorbit Consultants Contact us today to learn more about our services and how we can help you achieve compliance with GMP regulations.
At GxPorbit, we provide a wide range of consultancy services designed to help pharmaceutical, biotechnology, and medical device companies comply with Good Manufacturing Practice (GMP) regulations. Our team of experienced consultants has extensive knowledge and expertise in GMP and can help your organization implement and maintain GMP standards.
Our Key GMP consultancy services include:
GMP Remediation:
If your organization has received a warning letter or a citation for GMP non-compliance, we can help. Our GMP remediation services include a comprehensive review of your organization’s processes and systems, identification of areas of non-compliance, and development of a remediation plan.
Regulatory Filing:
We offer regulatory filing services to help your organization prepare and submit regulatory filings for GMP-related activities, including new product approvals, product variations, and license renewals.
Our consultants will work with you to ensure that regulatory filings are accurate, complete, and submitted on time. We will also provide guidance on regulatory requirements and assist you in addressing any regulatory issues that may arise.
Gap Assessment (Practices and Regulatory Expectations) Services:
We offer gap assessment services to help your organization identify gaps between current practices and regulatory expectations. Our consultants will work with you to assess your current practices and identify any gaps in compliance with regulatory requirements.
We will then provide recommendations for improvement and assist you in implementing solutions that meet regulatory requirements and are tailored to the needs of your organization.
Computerized Systems Gap Assessment:
We offer computerized systems gap assessment services to help your organization ensure that computerized systems used in GMP operations meet regulatory requirements.
Our consultants will work with you to assess your computerized systems and identify any gaps in compliance. We will then provide recommendations for improvement and assist you in implementing solutions that meet regulatory requirements.
Mock Inspection Services:
We offer mock inspection services to help your organization prepare for regulatory inspections and identify areas of non-compliance. Our consultants will conduct a simulated inspection of your facility, systems, and processes to identify any gaps in compliance.
We will then provide recommendations for improvement and assist you in implementing solutions that meet regulatory requirements and are tailored to the needs of your organization.
For Cause/Root Cause Inspection Services:
We offer for cause and root cause inspection services to help your organization address issues identified by regulatory agencies or internal audits. Our consultants will work with you to identify the root cause of the issue and develop a corrective action plan that meets regulatory requirements we will also assist you in implementing the corrective action plan.
GMP Compliance Assessments:
Our GMP compliance assessment service is designed to assess your organization’s compliance with GMP regulations. Our team will conduct a comprehensive review of your organization’s facilities, processes, and systems to identify areas of non-compliance and provide recommendations for improvement.
GMP Quality Systems:
We can help your organization develop and implement GMP quality systems that meet regulatory requirements. Our consultants will work with you to design a quality system that is tailored to the needs of your organization and provide guidance on implementation and maintenance.
GMP Training:
We offer GMP training services to help your organization meet GMP training requirements. Our training programs are tailored to meet the specific needs of your organization and can be delivered on-site or online.
Our training covers topics such as GMP basics, GMP regulations, GMP documentation, Cleaning validation principles, Process Validation, Elemental Impurities (ICH Q3D), Nitrosamine Impurities Risk Assessment, Effective investigation of Non-conformances, Basics of Computer System Validation (Annex 11/Part 11 BasicPrinciples and GAMP 5 requirements) and Principles of validation and qualification Etc.,
GMP Documentation:
We can help your organization develop and maintain GMP documentation, including Standard Operating Procedures (SOPs), batch records, and other GMP-related documentation. Our consultants will work with you to develop documentation that meets regulatory requirements and is tailored to the needs of your organization.
GMP Gap Analysis:
We offer GMP gap analysis services to help your organization identify gaps in your current GMP compliance status. Our consultants will conduct a thorough review of your organization’s facilities, processes, and systems to identify areas of non-compliance and provide recommendations for improvement.
GMP Supplier Audits:
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 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.
GMP Data Integrity:
We offer GMP data integrity services to help your organization ensure the accuracy, completeness, and consistency of GMP-related data. Our consultants will work with you to develop and implement data integrity policies and procedures that meet regulatory requirements.
GMP Quality Management System:
We offer GMP quality management system services to help your organization establish and maintain a quality management system that meets regulatory requirements. Our consultants will work with you to develop and implement a quality management system that is tailored to the needs of your organization.
Validation and Qualification Support Services:
We offer validation and qualification support services to help your organization ensure that equipment, processes, and systems are qualified and validated in accordance with regulatory requirements.
Our consultants will work with you to develop and implement validation and qualification protocols, execute validation and qualification activities, and prepare validation reports.
We will also provide guidance on regulatory requirements and assist you in addressing any validation and qualification issues that may arise.
If you are looking for reliable and experienced GMP consultancy services, look no further than GxPorbit Consultants Contact us today to learn more about our services and how we can help you achieve compliance with GMP regulations.
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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