GMP Audit Services – Ensure Compliance, Quality, and Global Trust

At Incredible Pharmaceutical Private Limited (IPPL), we provide comprehensive Good Manufacturing Practices (GMP) audit services to ensure that your pharmaceutical manufacturing processes meet national and international regulatory standards. Our audits are designed to enhance quality assurance, identify risks, and prepare your organization for inspections by authorities like WHO, USFDA, EMA, and others.

Why GMP Audits Are Important

GMP regulations are critical for ensuring the consistent quality, safety, and efficacy of pharmaceutical products. Non-compliance can result in:

• Regulatory penalties or shutdowns

• Product recalls or market bans

• Legal action or reputational damage

• Loss of customer trust and global market access

IPPL's GMP audits are a proactive approach to identifying non-conformities and ensuring sustained compliance.

Our GMP Audit Services Include

1. Internal GMP Audits

We evaluate your internal processes to identify gaps and non-compliances in quality systems, documentation, hygiene, and facility management before official inspections.

2. Pre-Inspection Audits

Before facing inspections from authorities like WHO, USFDA, or CDSCO, our experts conduct pre-inspection audits that simulate real regulatory visits, helping you prepare effectively.

3. Vendor and Supplier Audits

We assess third-party manufacturers and suppliers to ensure they meet your GMP requirements. These audits strengthen your supply chain and ensure consistent product quality.

4. Gap Analysis and Risk Assessment

Our structured gap assessments pinpoint areas of non-compliance and risk. This helps prioritize corrective measures and minimize the chance of critical observations.

5. Mock Audits and Staff Training

We simulate actual regulatory audits and train your staff to handle documentation, queries, and compliance protocols confidently during inspections.

6. CAPA Support (Corrective and Preventive Actions)

We assist you in planning and implementing effective corrective and preventive actions based on audit findings to ensure long-term GMP adherence.

Audit Coverage Areas

Our audits cover all major GMP elements including:

• Facility and equipment validation

• Raw material sourcing and storage

• Sanitation and hygiene practices

• Documentation and records management

• Manufacturing process control

• Quality control and assurance

• Packaging and labeling

• Personnel training and safety

• Product testing and distribution

Industries We Serve

Our GMP audit services are suitable for:

• Pharmaceutical formulation units

• Active Pharmaceutical Ingredient (API) manufacturers

• Biotech and biosimilar production facilities

• Herbal and nutraceutical companies

• Cosmetic and personal care manufacturers

• Contract manufacturing and research organizations

Our Audit Process

We follow a structured and transparent approach:

Step 1: Scope Understanding
We begin with a consultation to understand your facility, product type, and regulatory objectives.

Step 2: On-Site Audit
Our experts conduct a thorough evaluation of your operations, facility, documentation, and processes.

Step 3: Report & Recommendations
We provide a detailed report listing observations (critical, major, minor) and suggest actionable improvements.

Step 4: CAPA Guidance
We help you implement corrective and preventive actions with clear timelines and technical support.

Step 5: Follow-Up Review (if needed)
Optional follow-up audits ensure corrective actions are in place and effective.

Why Choose IPPL

• Experienced auditors with deep regulatory knowledge

• Customized audits based on your compliance goals

• End-to-end support from audit to CAPA implementation

• Strong presence across India, Southeast Asia, and Africa

• Transparent reporting and practical advice

Get Started Today

Partner with Incredible Pharmaceutical Private Limited (IPPL) for your GMP audit requirements. We help pharmaceutical companies operate with confidence by ensuring full compliance with global quality standards.

Contact us today to schedule a consultation and take the first step toward regulatory excellence.