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  • Pharma GxP Audit Services

Pharma GxP Audit Services

Compliance with GxP, ISO, and FDA regulations is essential. Pharma Wizard’s GxP audit services provide end-to-end vendor evaluations, audits, and closure support, as well as mock audits and focused compliance assessments.

Overview

Services

Expertise & Advantages

Pharma GxP Audit Services - Overview

When it comes to pharma/biotech/cosmetics/medical devices industries, quality can be defined by strong GxPs intended to be implemented and followed throughout the lifecycle. Pharmaceutical organizations find vendor evaluation (verifying compliance of multiple vendors to select the best vendor) and vendor audit (verifying compliance levels of existing vendors as part of a continual improvement process) challenging. To implement vendor evaluation and vendor GxP audit process, time-critical and ever-evolving GxP compliance requirements of manufacturing (GMP), distribution (GDP), clinical trials (GCP), laboratory (GLP (BA-BE, Clinical)), and process automation (GAMP) must be adhered to. In such scenarios, Pharma wizard can meticulously work with clients in vendor GxP audit evaluation and vendor auditing processes.

As part of vendor evaluation, Pharma wizard can provide GxP compliance consulting and verify the compliance levels of multiple vendors to submit the GxP audit reports to the clients. Subsequently, clients can decide on the selection of vendors based on Pharma wizard advice. Our GxP compliance consulting services are tailored to help organizations interpret and apply GxP guidelines across all operational areas. We ensure that your quality systems are always robust and audit-ready.

As part of the vendor audit program, Pharma wizard can perform GxP audit services on behalf of clients and manage vendor audits per the client’s calendar and requirements.
Vendor Evaluation Vendor Audit Mock Audit Target Audit Regulatory Audit Findings Closure
Evaluation of multiple potential vendors for third-party service or product Perform audit
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Audit report
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Follow up till closure 		Audit readiness mentoring Auditing an area/process, which is troublesome for the customer Designing CAPA with RCA for a Regulatory audit/customer audit finding

Evaluating the efficiency of CAPA
GMP, GCP, GLP (BA-BE, Clinical), GAMP, Data Centre for US (USFDA), EU, and emerging markets

Pharma wizard GxP Audit Services

Pre-submission Meetings/HA Interactions

Optimize HA interactions with seasoned expertise

Pharma GxP Audit Services

  • Expertise
  • Advantages

Vendor Evaluation

Your compliance status is as good as your defined and established processes. The system and procedures you follow to develop a drug/cosmetic/device should be aligned with established Regulatory standards and GxP guidelines. While a Regulatory authority decides upon certain good practices to be followed, the onus is on the organization that is involved in manufacturing, and vendors should set a procedural benchmarking to be aligned with applicable GxP regulations. We, at Pharma wizard, notice a rise in the number of procedural standards related to non-compliance issues, which suggests a potential gap in established quality management systems.

To enable organizations to align with Regulatory agencies right from the first step, Pharma wizard provides exclusive and comprehensive pharma GxP audit services, which include the provision of Standard Operating Procedures (SOPs), employee training on SOPs and best practices, and effective implementation of quality management systems and best practices with end-to-end GxP audit services. Pharma wizard can also help in vendor evaluation to select the best vendors as part of Regulatory and GxP compliance consulting.

Audit

  • Periodic GxP compliance audits with audit reports and recommendations of closure
  • Preparation of audit metrics to be presented to the management
Seamless Regulatory Process Implementation​

Audit, Report, and Closure

Processes are established, SOPs are defined, and resources are trained. With many questions surrounding your established systems’ capability to be compliant, it is imperative to adopt and implement vendor audit services that span across not only reporting and recommending necessary procedures but also include follow-up assistance for accurate and timely closure. We also organize GMP auditing services, vendor capability assessment, and audit-trial adequacy assessment in line with current requirements.

Being updated with the GxP audit and compliance requirements, Pharma wizard enables organizations to be audit-ready anytime. We offer need-based models for pharma GxP audit services to ensure the established processes are rightly aligned with industry standards.

Our GxP compliance services support organizations in achieving and maintaining complete GxP compliance.

Audit and Report

  • GMP audits
  • Vendor performance assessment
  • Compliance audit performance
  • Gap analysis checklist
  • Compliance audit report submission
  • Compliance assessment

Mock Audit

Audit and Closure

  • Compliance audit performance
  • Compliance audit report preparation/submission
  • Recommendations on closures
  • Problem resolution
  • Follow-up audit performance

Audit-readiness Mentoring

The concerning factor that any pharma/cosmetic/medical device company could think of is sudden audit notifications from Health Authorities (HAs). Not being prepared for an audit can be a challenge for organizations even when processes are established, and SOPs are defined on par with global standards. In such scenarios, the first thing companies should think about is whether their internal resources are equipped enough to face HA audits. With knowledge of HA requirements and audit & validation industry trends, Pharma wizard expert compliance team is well-positioned to understand your set procedures and mentor your internal systems to be audit-prepared even at the brink of a notification. We enable organizations to perform mock audits to address HA auditors.
  • Enabling mock audits
  • End-to-end audit-readiness mentoring program

Target Audit

Need-based audit models

There is no point in GxP compliance auditing the entire facility for a function-specific auditing notification. With clinical research programs and manufacturing activities spread across distinct functions, performing audits for every function proves costly, affecting the organization’s budgets. In such scenarios, targeting a specific process/area for a comprehensive audit is advisable.
Based on the client’s requirements in an audit report, findings closure, or follow-up, Pharma wizard dedicated team chooses a specific function or department to perform comprehensive audits instead of the entire organization. Here, the scope is limited to a specific function/area to stabilize the processes.
  • Function/Area/Process-specific GxP compliance auditing
  • Audit report
  • Findings closure
  • Follow-up

Regulatory Audit Findings Closure

Even with processes, SOPs, training, and internal audits in place, regulatory audits may still result in findings requiring timely corrective actions. Organizations must assess their capability to address these effectively and document closures.

With over 10 years of combined expertise in time-critical GxP audits and validation, Pharma Wizard ensures “right-first-time” closures by developing robust CAPA plans, performing precise root cause analysis, and evaluating CAPA effectiveness.

  • Design CAPA Plan
  • Conduct RCA
  • Evaluate the efficiency of CAPA
  • Ability to manage multi-site projects in a single audit plan/one iteration
  • Auditor skills (Subject Matter Expertise)
  • Scope of the audit that covers around 20 process areas
  • Ability to give the audit report - “Factual” as well as “Findings"
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