Site Gap Assessment Audit

QxP Pharma Consultants’ Site Gap Audit Services – Closing Compliance Gaps with Proven GMP Expertise
Ensure your pharmaceutical facility is regulatory inspection-ready with our expert Pharma Site Gap Assessment Audit Services.
At QxP Pharma Consultants & GMP Services, we offer comprehensive, customized solutions to identify and resolve compliance gaps, enabling you to meet stringent global quality standards, including FDA, EU GMP, and WHO GMP.
As one of the leading Pharma Consultants in India , we specialize in preparing facilities across the country through GMP Compliance Gap Assessments, Mock Audits, and QMS Gap Analysis, helping clients move confidently toward regulatory approval.

Why Pharma Site Gap Assessment Audit is Critical?
Modern pharmaceutical manufacturing is governed by Good Manufacturing Practices (GMP) and GxP (Good Practice) standards.
Any deviation or gap in compliance can result in costly delays, warning letters, or product recalls. That’s where Site Gap Assessment Audits come into play.
A well-structured Pre-Audit Gap Assessment for Pharma Plants:
Identifies regulatory non-conformances before actual inspections
Minimizes the risk of audit failures
Helps build a culture of continuous quality improvement
Ensures smooth Regulatory Submissions and Approvals
Whether your facility is gearing up for an FDA Inspection, EU GMP inspection, or an internal corporate audit, QxP’s services offer a strategic advantage.

About QxP Pharma Consultants in Ahmedabad
With headquarters in Ahmedabad, QxP Pharma Consultants & GMP Services are among the top GMP Services Providing in Ahmedabad and GMP Services Providing in India.
Our specialists bring decades of collective experience from regulatory bodies and the pharmaceutical industry, offering unrivaled expertise in:
Comprehensive GMP Site Audit Services
Regulatory Gap Assessments for Pharma Facilities
Manufacturing Site Gap Assessment Solutions
QMS Gap Assessment and Remediation Planning
Our team follows a structured, audit-based methodology that is adaptable across dosage forms, including oral solids, injectables, biologics, APIs, and sterile products.

1. Pre-Audit Planning and Kick-off
We begin by understanding the scope of operations, compliance history, and regulatory goals. A project plan is shared outlining timelines, documents needed, and audit checklists.

2. On-Site Inspection and Documentation Review
Our auditors conduct a GMP-focused review of:
Quality Management Systems
Production & Process Controls
Facilities & Equipment
Laboratory Controls
Data Integrity Compliance
Risk Management Programs
This phase also includes Mock Audit and Gap Identification Services, simulating a real-time inspection experience.

4. QMS Gap Assessment and Remediation Planning
Our team collaborates with your staff to:
Develop Corrective and Preventive Action (CAPA) plans
Redesign SOPs where needed
Train personnel for audit readiness
Implement quality improvements
We also assist in GxP Site Readiness Audits to verify the effectiveness of remediation activities.

Key Features of Our Site Gap Assessment Services
FDA Inspection Gap Assessment: Our auditors simulate FDA audit expectations, flagging issues that could result in 483 observations or warning letters.
EU GMP Site Gap Audit Experts: With deep knowledge of EMA expectations, our consultants tailor audits for EU GMP certification, a must for exports to the EU.
Mock Audit and Gap Identification Services: Experience a realistic regulatory inspection scenario, preparing your team to respond effectively.
Quality System Gap Assessment: We assess the robustness of your Quality Management System (QMS) and ensure it aligns with ICH Q10, ISO 9001, and other global standards.
Site Gap Analysis for Regulatory Compliance: Detailed checklists aligned with 21 CFR Part 210/211, EU Annexes, Schedule M, and WHO TRS ensure complete regulatory mapping.

Why Choose QxP Pharma Consultants?
Proven Track Record: Trusted by leading pharma and biotech firms across India and globally.
Customized Audits: We align assessments to your operational scope, dosage form, and target market.
Based in Ahmedabad, Serving All of India: We are strategically positioned among the best GMP Services Providing in Ahmedabad and GMP Services Providing in India.
End-to-End Solutions: From gap assessment to CAPA closure and re-audits, we provide audit-ready site compliance services.

Let’s Make Your Facility Audit-Ready
The regulatory landscape is evolving. Don’t wait for an inspection to reveal compliance problems.
Let Pharma Consultants in India help you become inspection-ready through expert Site Gap Assessment Audit Services.
Whether you’re targeting local licenses or international markets, our Comprehensive GMP Site Audit Services are designed to give you a competitive edge.
Take the first step toward compliance. Request a Gap Assessment Audit today and make your pharma facility regulatory-inspection ready.

QxP Pharma Consultants’ Site Gap Audit Services – Closing Compliance Gaps with Proven GMP Expertise