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Qualandre Pharmaceutical Services

European Good Manufacturing Practice Audits of Pharmaceutical Plants in China

Chinese manufacturing. European GMP.

Who We Are

QLD (Qualandré) is based in China, right where many pharmaceutical ingredients are manufactured. It is a Belgian company whose registration and office are in Hangzhou, Zhejiang Province.

Our sole activity is to audit pharmaceutical good practice, like GMP, GDP, GLP, etc. This is more than enough to keep us busy! We audit sterile and non-sterile APIs, intermediates, medicinal products, injectable formulations, biological products, excipients, packaging materials, medical devices, herbal products, and distribution.

The auditing standards are the European GMP Guide, ICH Q7, 21 CFR Parts 210 and 211, WHO GMP, IPEC GMP, or ISO 9001, while taking account of guidance from the EMA, FDA, EDQM, and other authorities on topics like data integrity, change control, OOS investigations, and others.

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Pharmaceutical Manufacturing Facility

Trusted by Industry Leaders

If you don't know us yet, most manufacturers of active pharmaceutical ingredients already do. QLD auditors are a regular fixture in Chinese pharmaceutical factories.

15+ Years

Experience in GMP Audits across Asia since 2008

1000+

Audits conducted for 400+ global clients

100%

Compliance with EU, FDA, WHO, and ICH standards

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Audit Library & Methodology

Comprehensive audit frameworks based on international standards and regulatory expectations.

Standards We Audit Against

  • • European GMP Guide
  • • ICH Q7
  • • 21 CFR Parts 210 and 211
  • • WHO GMP
  • • IPEC GMP
  • • ISO 9001

Regulatory Guidance Followed

  • • EMA Guidelines
  • • FDA Expectations
  • • EDQM Standards
  • • Data Integrity (ALCOA+)
  • • Change Control
  • • OOS Investigations
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Meet Our Team

Experts with deep experience in pharmaceutical compliance and auditing in China.

Philippe André

Philippe André

Founder & Lead Auditor

Over 15 years of experience inspecting pharmaceutical plants across Asia since 2008.

PhJ André

PhJ André

Senior GMP Auditor

Specialized in sterile manufacturing and biological products.

Silvia

Silvia

Quality Systems Auditor

Expertise in data integrity, documentation, and change control.

Audit Team

Audit Team

Multilingual Auditors

Fluent in English, Chinese, French, and technical GMP terminology.

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Our Audit Services

Comprehensive GMP audit solutions tailored to your supply chain needs in China.

Sterile API Audit

Sterile API GMP Audit

Full compliance review of sterile active pharmaceutical ingredient manufacturing.

  • • Aseptic processing
  • • Environmental monitoring
  • • Media fill validation
  • • Sterility testing
Non-Sterile API Audit

Non-Sterile API Audit

Evaluation of chemical synthesis, purification, and packaging processes.

  • • Process validation
  • • Impurity profiling
  • • Cleaning validation
  • • Stability studies
Medicinal Products Audit

Medicinal Products Audit

GMP compliance for finished dosage forms including tablets, capsules, and liquids.

  • • Batch record review
  • • Packaging integrity
  • • Label control
  • • Release testing
Injectable Formulations Audit

Injectable Formulations Audit

Specialized audit for parenteral drug products with high sterility assurance.

  • • Terminal sterilization
  • • Aseptic filling
  • • Particulate control
  • • Pyrogen testing
Biological Products Audit

Biological Products Audit

Comprehensive review of biologics, vaccines, and cell-based therapies.

  • • Cell bank management
  • • Viral clearance
  • • Potency assays
  • • Cold chain validation
Excipients & Packaging Audit

Excipients & Packaging Audit

Audit of raw materials, excipients, and primary packaging components.

  • • Supplier qualification
  • • Identity testing
  • • Leachables & extractables
  • • Compatibility studies
Medical Devices Audit

Medical Devices Audit

GMP and ISO 13485 compliance for Class I-III medical devices.

  • • Design controls
  • • Risk management (ISO 14971)
  • • Sterilization validation
  • • Biocompatibility
Herbal Products Audit

Herbal Products Audit

GMP compliance for traditional Chinese medicine and herbal extracts.

  • • Botanical identification
  • • Pesticide residue testing
  • • Heavy metal analysis
  • • Microbial limits
Distribution & GDP Audit

Distribution & GDP Audit

Good Distribution Practice audit for supply chain integrity.

  • • Cold chain management
  • • Transport validation
  • • Anti-counterfeiting
  • • Recall procedures
Data Integrity Audit

Data Integrity Audit

ALCOA+ compliance review of laboratory and production data.

  • • Audit trail review
  • • Electronic records
  • • Raw data retention
  • • System access controls
OOS & Deviation Audit

OOS & Deviation Audit

Root cause analysis and investigation process evaluation.

  • • Investigation timelines
  • • CAPA effectiveness
  • • Trend analysis
  • • Management review
Integrated Quality System Audit

Integrated Quality System Audit

Holistic review of entire quality management system.

  • • Quality policy
  • • Management responsibility
  • • Internal audits
  • • Continuous improvement
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Cost-Effective Audit Solutions

Sharing audits between several customers of the same manufacturer saves costs and enables the manufacturer to better focus on any deficiencies.

Why Share Audits?

  • • Reduce audit planning burden on suppliers
  • • Lower costs for all participating clients
  • • Minimize disruption to manufacturing operations
  • • Promote transparency and trust in the supply chain

Exclusive Audits Also Available

For sensitive or high-risk suppliers, we offer confidential, exclusive audits with full client control over scope and reporting.

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Frequently Asked Questions

What regions do you cover?

We are based in Hangzhou, China, and conduct audits throughout mainland China. We also have experience in other Asian countries including India, South Korea, and Thailand.

Which GMP standards do you follow?

We audit against European GMP, ICH Q7, 21 CFR 210/211, WHO GMP, IPEC GMP, and ISO 9001, incorporating guidance from EMA, FDA, and EDQM.

Can audits be conducted in languages other than English?

Yes, our auditors are fluent in English, Chinese, and French, and can conduct audits in any of these languages.

How long does a typical audit take?

Most audits take 2-3 days on-site, depending on the complexity of operations. The full process including report writing and review takes 2-4 weeks.

Do you offer follow-up audits?

Yes, we provide follow-up audits to verify CAPA implementation and ongoing compliance. These can be scheduled at 3, 6, or 12-month intervals.

Contact Us

For audit requests and inquiries, please visit our official website.

Email: [email protected]

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