GXP Auditing

 

The foundation of our regulated pharmaceutical and medical device industry is its quality systems.  Companies need to build and implement such systems and to monitor their success on a continual basis.  GXP farma provides expert Quality Assurance consulting services to pharmaceutical, biotechnology, medical device, and dietary supplement companies to help ensure they are in compliance with regulations of USFDA and other competent authorities. Our team of auditors can perform a detailed assessment of your existing quality systems and processes and identify both the good and potentially problematic aspects of this key support system. We will help you strengthen all aspects of compliance, as they impact your products.

 

GXP farma can also offer expert advice and guidance in the preparation of SOPs, quality manuals, laboratory quality issues, assist with the establishment of quality management systems, and the planning of routine monitoring programs. In addition, we can conduct GXP audits of potential vendors, CRO and CMO candidates, process development and formulation laboratories, as well as manufacturing and packaging facilities.

 

 

GXP farma Auditing Services

 

Compliance Audits

GXP farma can develop a detailed assessment of your quality systems to assist you in preparing for inspections by Regulatory Authorities, clients and corporate partners involving Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Quality System Regulations (QSR). Our experience spans the areas of biotechnology, pharmaceutical and medical device companies. GXP farma can conduct compliance audits/assessments of your third-party contractors and vendors and can assist you in preparing for FDA pre-approval inspections of manufacturing facilities and other regulatory authority inspections.

 

Clinical Trial Audits

GXP farma also conducts study-specific GCP audits of protocols, investigator sites, master files, pharmacovigilance, databases and reports for a wide variety of clinical studies. The audits will be designed to keep you and your organization compliant with USFDA BIMO regulations regardless of where the trial may be conducted.

 

Laboratory Audits

GXP farma offers expert advice and guidance in laboratory quality issues, assisting with the establishment of quality management systems, the preparation of laboratory policies and SOPs, and the planning of routine monitoring and Quality Control analytical test procedures. Supporting both non-GLP and GLP pre-clinical work, as well as clinical (GCLP) and product analytical testing (GMP) laboratories, GXP farma assures that data are robust and credible and are in compliance with protocols, SOPs and regulatory requirements.

 

Manufacturing Audits

GXP farma brings their years of hands on experience in manufacturing (small molecule, biologic, and drug substance) to help support your QA needs. GXP farma coordinates the conduct of GMP audits of process development and formulation laboratories, as well as manufacturing, distribution and packaging facilities.

 

Additionally, we work with clients on:

·       Post-audit follow-up actions

·       SOP writing and system implementation services

·       Managing CMC projects with third-party vendors and contract facilities

·       Preparing and reviewing third-party quality agreements for contract manufacturers

·       Pre-approval inspection (PAI) readiness and post-audit responses

·       Operational readiness and sustainability programs·      

 

Strategic Audits

Prospective merger and acquistion actions can best be supported if you understand the current regulatory and quality attributes of the potential target.  GXP farma's extensive experience can help make you more succesful by identifying potential issues before you make the deal.  Take advantage of the entire spectrum of GXP farma's focused audit approaches today.

           Internal audits prior to major organizational changes

           Due diligence of product and facility acquisitions

 

Corrective Action and Preventive Action (CAPA) Programs

Perhaps no one program can be seen as more of the cornerstone of continual quality improvement than is the Corrective Action and Preventive Action or CAPA program.   GXP farma customizes a CAPA program for you based on your product, your regulatory environment and your personnel to create a living system that maintains regulatory compliance and also promotes good business practices that help your company’s bottom line.

We work with clients on:

  • Creating a CAPA Plan

  • Creating a Quality Culture that facilitates the implementation of CAPA activities 

  • Follow-up and tracking of open CAPA actions

  • Integrating training and company culture in continuous improvement and compliance activities