Contract Manufacturing Audit

QxP Pharma Consultants’ Contract Manufacturing Audit – Trusted GMP Services for CMO Qualification and Regulatory Assurance
In the dynamic world of pharmaceutical manufacturing, ensuring that third-party and contract manufacturing organizations (CMOs) adhere to regulatory expectations is critical for patient safety, product quality, and business reputation.
QxP Pharma Consultants & GMP Services, a leading name among Pharma Consultants in India, specializes in Contract Manufacturing Audit Services to help pharmaceutical companies ensure GxP compliance, regulatory readiness, and high-quality standards across outsourced operations.

Whether you’re partnering with a new CMO or requalifying an existing one, QxP Pharma Consultants in Ahmedabad delivers comprehensive, audit-ready solutions tailored to meet national and international compliance requirements.

Ensuring Compliance with Global Regulatory Standards
Pharmaceutical companies outsourcing manufacturing must ensure their CMOs comply with stringent guidelines such as WHO-GMP, US FDA, EU GMP, MHRA, and other global regulatory standards.
A robust Contract Manufacturing Audit plays a pivotal role in confirming that the manufacturer operates within the required framework, minimizing risk exposure.

Safeguarding Product Quality and Patient Safety
A Contract Manufacturing Quality Audit verifies that the production processes, quality systems, data integrity measures, and documentation are all aligned with Good Manufacturing Practices (GMP).
This directly impacts the safety and efficacy of the final product.

Meeting Regulatory and Business Expectations
Regulatory bodies increasingly scrutinize outsourced manufacturing facilities. Hence, a Regulatory Audit for Pharma CMOs is not just a compliance requirement—it’s a strategic imperative.
Moreover, a well-executed audit fosters accountability, strengthens vendor relationships, and enhances overall supply chain transparency.

Audit Methodology at QxP Pharma Consultants
Our Contract Manufacturing Audit Services follow a structured, risk-based audit model:
Audit Planning and Scope Definition: We collaborate with your QA/RA teams to understand your expectations, product types, and compliance needs before customizing the audit protocol.
On-site Inspection or Remote Audit: Our auditors assess the facility’s layout, cleanliness, equipment qualification, documentation practices, data integrity, and compliance with applicable GMP norms.
Documentation and Report Preparation: Post audit, we generate a detailed report outlining observations, categorizing them into critical, major, and minor non-conformances.
Corrective and Preventive Action (CAPA) Follow-up: We help your CMO implement effective CAPAs and conduct follow-up assessments to verify closure.
Regulatory and Requalification Support: Our experts provide guidance on requalification strategies and support interactions with regulatory authorities during inspections.

Trusted GMP Services Providing in India
QxP Pharma Consultants & GMP Services is recognized for its comprehensive and regulatory-aligned approach to GMP Audit for Contract Manufacturers.
Our auditors have extensive knowledge of FDA, EMA, WHO, and CDSCO inspection requirements and are skilled in identifying hidden compliance risks.

Experienced Pharma Consultants in India
Experienced professionals in pharma audits, contract manufacturing, outsourcing, and supplier compliance services

End-to-End Support for Audit Readiness
From pre-audit planning and documentation review to CAPA monitoring and regulatory correspondence, QxP Pharma Consultants in Ahmedabad offers 360° support for your outsourced audit needs.

Industries and Product Segments We Serve
Our Contract Manufacturing Audit Services span across various pharma and biotech segments:
Solid Oral Dosage Forms (Tablets, Capsules)
Injectables and Sterile Products
Ophthalmic and Nasal Preparations
Topical and Dermatological Products
Biopharmaceuticals and Vaccines
Active Pharmaceutical Ingredients (APIs)
Herbal and Nutraceutical Products
Ensure CMO compliance and excellence in raw material manufacturing audits.

Partner with the Experts in GMP Compliance and CMO Audits
If you’re outsourcing pharmaceutical manufacturing, don’t leave compliance to chance.
Trust QxP Pharma Consultants & GMP Services—the preferred Pharma Consultants in India—to safeguard your business from regulatory setbacks and quality deviations.
Our Contract Manufacturing Audit Services are designed to provide actionable insights, mitigate risks, and foster long-term quality partnerships with your CMOs.
Let’s ensure your third-party manufacturing sites are always audit-ready, GMP-compliant, and aligned with your corporate quality objectives.

QxP Pharma Consultants’ Contract Manufacturing Audit – Trusted GMP Services for CMO Qualification and Regulatory Assurance