GxP Services Explained: What to Look for in a GxP Compliance Partner Summary

What is GxP?

GxP (Good “x” Practices), with “x” referring to the specific area for compliance has been established by FDA to set out good practice guidelines for highly regulated industries like pharmaceuticals, medical devices, biotechnology, and other life science industries. This is essential for maintaining product quality, safely and efficacy. The common GxP types include but are not limited to: GMP (Good Manufacturing Practice); GLP (Good Laboratory Practice); GCP (Good Clinical Practice); GVP (Good Pharmacovigilance Practice); GDocP (Good Documentation Practice); GDMP (Good Data Management Practice) and GAMP (Good Automated Manufacturing Practice).

What is GxP Service?

GxP services are support services being offered by external consultants and have been highly sought-after by companies to solve their GxP related challenges and uphold best practices. In life science industry, this is crucial for growth and sustainability considering stricter requirements brought about by increasing regulations and technological advancements. Some GxP services that are widely utilized nowadays include:

1. GxP Systems Compliance

• ERP/Software Validation. Provides computerized systems validation in relation to GAMP 5 guideline and 21 CFR Part 11 regulation.
• Risk Assessment. Helps identify, evaluate, and mitigate potential risk that could impact the quality, safety and compliance of systems and processes.
• Laboratory Systems Compliance. Ensures the approach, policy and procedures in place meet industry and standards and regulatory requirements, maintaining high quality and integrity in laboratory operations.
• Change Control Management. Verifies that system modifications are properly documented and justified, while considering impact on quality, compliance, and safety.
• IT Vendor Audit. Performs software developer examination to ensure compliance with the applicable regulatory standard in relation to FDA’s 21 CFR Part 11.

       2. Quality Assurance

• Policies and Procedures Development. Helps to create effective quality policies and procedures that covers manufacturing, laboratory practices, clinical trials, and distribution aspects of operation.
• Regulatory Education & Trainings. Holds training programs ensuring that the staff are fully trained and responsibilities are clearly defined to address the evolving regulatory landscape covering various aspects of GxP.

       3. Digital Compliance

• Cloud Infrastructure Qualification. Ensures companies using private clouds meet the applicable compliance standards while incorporating identification of potential GxP impacts, assessment of associated risks.
• Data Compliance. Arranges classified data following the business standards and governing regulations such as such GDPR (General Data Protections Regulation) and GxP requirements which allow for strategies to manage data integrity and data compliance.
• IT Policies and Procedures Development. Helps to create comprehensive IT Quality Policy/SOP ensuring proper deployment and maintenance of software applications to support compliance with regulatory requirements.

Choosing a GxP Compliance Partner

Appropriate support is critical for companies to achieve compliance to different GxP regulations. When selecting a GxP compliance partner, several key factors should be considered to meet regulatory requirements and ensure high standard outcomes. Below is a guide on what to look for in a compliance partner outline and other things to consider when selecting one.

1. Service Offerings. Check for the comprehensive list of the GxP services that they offer. The wider the available service offerings for a specific focus area, the better flexibility they can provide to suit your needs.

2. Expertise/Specialization. Know the specific services they specialize in and the niche/industry they’ve mostly worked with. In addition, know if they have exposure and knowledge with the system you are using. This will help you assess if they can ensure sustainable compliance support across your complex business processes.

3. Case Studies. Check for their various projects and their offered solutions to differing client issues and needs.

4. Client Feedback. Look for client testimonials. Be keen if they have repeating projects/engagements to verify if they have been consistently providing quality services to clients.

5. Request for their resource line up. Tenured employees with several experiences specializing in GxP services are skilled and efficient in delivering seamless integration.

6. Technology and Tools. Inquire if they have exposure and knowledge on the different ERP systems and do have the proper tools and methodology for their provided services.

7. Value and Pricing. Having several options on hand specially if you are in a budget for the compliance project is a great approach to balance the pros and cons between the quality of the deliverable and the price it would require finishing the project.

Why Consider Arbour Group as your GxP partner?

Arbour Group have been providing GxP services for over 30 years and have gained solid experience to partner and help you with your GxP compliance. We have a substantial track record spanning to 250 life science companies worldwide. Our qualified team of consultants are adept with GxP regulatory standards and guidelines and have speciality in handling end-to-end ERP systems validation. Contact us so we can assist you with audit preparedness, establishing robust compliance strategies, document readiness, and quality system alignment to meet the GxP regulatory requirements with confidence.