GXP Audits

PharmaGXP offers range of GxP Services for APIs, intermediates, Manufacturing, Transport and Storage facilities of medicinal products.

GMP Audits

At PharmaGXP, we offer comprehensive Good Manufacturing Practice (GMP) audit services conducted by our team of experienced and certified auditors.

Specializing in audits for Active Pharmaceutical Ingredients (APIs), intermediates, excipients, finished dosage forms, and packaging materials, our services are designed to ensure that your manufacturing processes meet all regulatory standards for quality and safety.

Why Choose PharmaGXP for GMP Audits?

Our GMP audit services are vital for maintaining compliance with international pharmaceutical manufacturing standards. We provide:

Expertise Across the Pharmaceutical Supply Chain: Our auditors have extensive knowledge in auditing APIs, intermediates, finished products, and packaging materials, ensuring a thorough evaluation of your entire supply chain.
Certified Auditors: Each of our auditors is certified and brings years of industry experience to provide you with insights and recommendations that help you not only meet but exceed regulatory expectations.
Customized Audit Plans: We tailor our audits to the specific needs of your facilities and products, focusing on areas critical to your operations and compliance requirements.

Our GMP Audit Services Include:

Pre-Audit Assessment: We conduct a preliminary assessment to understand your current practices and identify key areas of focus for the audit.
On-Site Audits: Our auditors perform detailed on-site evaluations to assess compliance with GMP standards, focusing on processes, personnel, facilities, equipment, materials, and documentation.
Compliance Reporting: We provide comprehensive reports detailing audit findings, including any non-conformances, risks, and areas for improvement.
Corrective Action Plans: Based on the audit outcomes, we help develop and implement effective corrective action plans to address any issues identified.
Follow-Up Audits: To ensure ongoing compliance and continuous improvement, we offer follow-up audits and monitoring services.
Regulatory Guidance: Our auditors are well-versed in the latest regulations and can provide guidance on how to stay compliant with evolving industry standards.

Enhance Your Compliance and Quality Assurance Partnering with PharmaGXP for your GMP audit needs ensures that your pharmaceutical manufacturing operations adhere to the highest standards of quality and compliance. Our goal is to help you identify opportunities for improvement, mitigate risks, and maintain a competitive edge in the market.

Contact PharmaGXP today to schedule a consultation and learn more about how our GMP audit services can benefit your business.

GLP Audits

GLP Audit Services by PharmaGXP for Third-Party Testing Laboratories in the UK and EU

PharmaGXP offers specialized Good Laboratory Practice (GLP) audit services, tailored for third-party testing laboratories operating in the UK and EU.

Our team of experienced and certified auditors ensures that your laboratory operations meet the stringent GLP standards required by regulatory agencies.

Why Choose PharmaGXP for GLP Audits?

Our GLP audit services are essential for laboratories that need to demonstrate compliance with regulatory expectations for safety, quality, and integrity of data.

Here’s why PharmaGXP stands out:

Expertise in GLP Requirements: Our auditors have deep knowledge of the GLP principles as specified by the UK MHRA, European Medicines Agency (EMA), and other relevant bodies.
Certified Auditors: Each auditor in our team is certified and possesses extensive experience in laboratory practices, providing you with credible and insightful audits.
Comprehensive Service Coverage: We cover all aspects of laboratory operations, from equipment validation and maintenance to staff training and data integrity.

Our GLP Audit Services Include:

Initial Consultation: We begin with a thorough consultation to understand your laboratory’s specific needs and compliance goals.
Detailed Audit Planning: Our audits are meticulously planned to ensure comprehensive coverage of all GLP areas, tailored to your laboratory’s operations.
On-Site Audits: Conducting on-site evaluations, our auditors examine your processes, documentation, personnel qualifications, equipment, and data handling practices.
Audit Reporting: We provide detailed audit reports outlining findings, compliance status, and recommendations for improvement.
Corrective Action Support: If issues are identified, we assist in developing and implementing corrective action plans to address gaps and enhance compliance.
Regulatory Advisory: Our experts offer ongoing guidance to help you navigate changes in GLP regulations and maintain compliance over time.

Enhance Your Laboratory’s Compliance and Operational Excellence Partnering with PharmaGXP for GLP audits ensures that your laboratory operations are compliant with regulatory standards, enhancing the credibility of your testing results and supporting your commitment to quality.

Our goal is to provide you with the insights needed to optimize your practices, ensuring reliability and integrity in every test you perform.

Contact PharmaGXP today to find out how our GLP audit services can help elevate your laboratory’s standards and ensure compliance in the ever-evolving regulatory landscape of the UK and EU.

GDP Audits

GDP Audit Services by PharmaGXP: Ensuring Excellence in Pharmaceutical Distribution

PharmaGXP offers specialized Good Distribution Practice (GDP) audit services, delivered by our team of experienced and certified auditors, including associated ex-MHRA inspectors.

Our services are designed to enhance compliance and operational efficiency for entities involved in the storage and transportation of medicinal products within the UK and EU markets.

Why PharmaGXP for Your GDP Audit Needs?

Our team's unique blend of expertise, including insights from former MHRA inspectors, provides an unparalleled depth of understanding of regulatory expectations.

This positions us to offer superior GDP compliance, gap analysis, and validations for contract storage sites and transportation services.

Our Comprehensive GDP Audit Services Include:

GDP Compliance Audits: We conduct thorough evaluations of your distribution practices against GDP guidelines to ensure complete adherence to regulatory standards.
GAP Analysis: Identifying and addressing discrepancies between your current practices and regulatory requirements, facilitating a roadmap to full compliance.
Audits of Contract Storage Sites: Ensuring that facilities storing medicinal products meet all GDP requirements, focusing on critical aspects such as temperature controls, security, and handling procedures.
Audits of Contract Transportation: We assess your transportation arrangements to guarantee that they comply with stringent regulations necessary for the safe and secure distribution of pharmaceuticals.
Validation Services: Validating that your logistical and storage processes and equipment function within set parameters essential for maintaining product integrity and quality.
Detailed Reporting and Recommendations: Each audit is followed by a detailed report that outlines our findings and provides clear, actionable recommendations for enhancements.
Ongoing Support and Consultation: Beyond initial audits, we offer ongoing consultancy and support to help implement improvements and adapt to regulatory changes, ensuring sustained compliance.

Partner with Experts in Pharmaceutical Distribution PharmaGXP is committed to upholding the highest standards of quality and safety in pharmaceutical distribution.

Our auditors, including ex-MHRA inspectors, bring a level of expertise that not only ensures compliance but also fosters confidence among your stakeholders and regulators.

Choose PharmaGXP for GDP audit services that go beyond mere compliance checks, providing strategic insights and practical solutions tailored to enhance the efficiency and integrity of your pharmaceutical distribution operations.

Contact PharmaGXP today to secure the guidance of experienced auditors and ensure your distribution processes meet all required GDP standards.