Our GMP Auditing Services

Good Manufacturing Practice is the foundation on which every safe medicine rests. At GxP Cellators, our GMP auditing services give you a clear, honest, and actionable picture of how well your manufacturing operations comply with the regulations that govern your markets. Our auditors walk your floors, review batch records, and trace deviation history to find gaps before inspectors do.

Global Regulatory Frameworks We Audit Against

United States FDA GMP Requirements

The FDA sets current Good Manufacturing Practice requirements in 21 CFR Parts 210 and 211. These regulations establish minimum requirements for methods, facilities, and controls used in manufacturing, processing, packing, and holding of drug products. Buildings must be clean, sanitary, and free of infestation. Equipment surfaces must not be reactive, additive, or absorptive. Automated systems require calibration, inspection, and controls over master production records. Data integrity requirements mandate true, complete, and secure backup data, original or true copy records, complete batch production records, and complete laboratory test data.

Summary of Key FDA Requirements:

21 CFR Parts 210 and 211 establish minimum GMP requirements
Buildings must be clean, sanitary, and free of infestation
Written sanitation procedures required for all operations
Equipment surfaces must not be reactive, additive, or absorptive
Equipment must be cleaned, maintained, and sanitized at appropriate intervals
Written cleaning and maintenance procedures required
Automated equipment must be routinely calibrated and inspected
Computer system controls required for master production records
Input and output verification required based on system complexity
21 CFR 211.68: Backup data must be true, complete, and secure
21 CFR 211.180: Records must be original or true copies
21 CFR 211.188: Complete batch production records required
21 CFR 211.194: Complete laboratory test data required

European Union EMA GMP Requirements

The EMA coordinates GMP requirements through EudraLex Volume 4, divided into Parts and Annexes. Part I covers Basic Requirements for Medicinal Products, including Pharmaceutical Quality System, Personnel, Premises and Equipment, Documentation, Production, Quality Control, Outsourced Activities, Complaints and Product Recall, and Self Inspection. Part II covers Active Substances. Annex 1 covers Sterile Medicinal Products, Annex 2 covers Biological Products, Annex 11 covers Computerised Systems, and Annex 15 covers Qualification and Validation. National competent authorities enforce these guidelines through inspections.

Summary of Key EU GMP Requirements:

EudraLex Volume 4 contains all EU GMP requirements
Part I: Basic Requirements for Medicinal Products
Chapter 1: Pharmaceutical Quality System
Chapter 2: Personnel requirements
Chapter 3: Premises and Equipment
Chapter 4: Documentation
Chapter 5: Production
Chapter 6: Quality Control
Chapter 7: Outsourced Activities
Chapter 8: Complaints and Product Recall
Chapter 9: Self Inspection
Part II: Basic Requirements for Active Substances
Annex 1: Manufacture of Sterile Medicinal Products
Annex 2: Manufacture of Biological Products
Annex 11: Computerised Systems
Annex 15: Qualification and Validation

Health Canada GMP Requirements

Health Canada regulates GMP through the Food and Drug Regulations and Guidance Document GUI-0001. Requirements address premises, equipment, personnel, sanitation, raw material testing, manufacturing control, quality control, finished product testing, stability testing, and documentation. Buildings must be clean, sanitary, and free from infestation. Personnel require medical examination before access to exposed drug areas. API specifications must be drawn from a pharmacopoeia or equivalent. Analytical methods must give accurate and consistent results. Identity tests are required on each container of API lot. Uniformity demonstration requires at least three consecutive batches.

Summary of Key Health Canada GMP Requirements:

GUI-0001 provides interpretation of GMP requirements
Buildings must be clean, sanitary, and free from infestation
Medical examination required before access to exposed drug areas
Training requirements and supervisory qualifications addressed
API specifications must be drawn from a pharmacopoeia or equivalent
Raw material specifications must conform to marketing authorization
Water must meet applicable standards including microbial limits
Analytical methods must give accurate and consistent results
Identity test required on each container of API lot
Critical manufacturing processes must produce consistent results
Uniformity demonstration requires at least three consecutive batches

United Kingdom MHRA GMP Requirements

The MHRA regulates GMP in the UK through the Orange Guide, which serves as the authoritative source for UK GMP. Inspections cover Manufacturer's Licences and Manufacturing Specials licences. Hot topics include Pharmaceutical Quality System compliance, staffing requirements, capacity monitoring, sterility assurance controls, and material transfer controls. Common findings include issues with assessment robustness, criticality assignment, and change control management. Recalls must be rapid and timely. Data Integrity guidance requires retained audit trails, no shared or generic user accounts, and progress toward system upgrades with individual login and audit trails for legacy automation systems.

Summary of Key MHRA GMP Requirements:

Orange Guide serves as authoritative source for UK GMP
Inspections cover Manufacturer's Licences and Manufacturing Specials
Hot topics include Pharmaceutical Quality System compliance
Staffing requirements and capacity monitoring assessed
Sterility assurance controls and material transfer controls reviewed
Prospective assessments required for changes
Impact to licence and capacity must be considered
Effectiveness checks required after changes
Recalls must be rapid and timely
Data Integrity guidance requires retained audit trails
Shared or generic user accounts should not be used
Legacy systems should demonstrate progress toward upgrades
Individual login and audit trails expected for automation systems

World Health Organization GMP Guidelines

The WHO publishes GMP guidelines as an international reference for regulatory authorities and manufacturers. These guidelines are published in the WHO Technical Report Series and compiled in the Quality Assurance of Pharmaceuticals compendium. The 10th edition, Volume 2, covers GMP and Inspection, including main principles, starting materials, specific medical products, water for pharmaceutical use, sampling, quality control laboratories, and HVAC systems for non sterile products. The 2024 to 2027 work plan includes revision of main principles and new guidelines for excipients. WHO guidelines are used by many national authorities and serve as a reference for WHO prequalification programs.

Summary of Key WHO GMP Guidelines:

Published in WHO Technical Report Series
10th edition compendium covers GMP and Inspection
Includes main principles for pharmaceutical products
Covers starting materials including APIs and excipients
Addresses specific medical products including sterile and biological
Includes water for pharmaceutical use guidelines
Covers sampling of pharmaceutical products
Addresses quality control laboratories
Includes HVAC guidelines for non sterile products
Revised periodically to reflect advances
Used by national authorities as basis for requirements
Reference for WHO prequalification programs

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

PIC/S is an international arrangement between regulatory authorities that develops harmonized GMP standards and provides inspector training. The PIC/S Guide PE 009 is used by many authorities as their GMP standard. Part I covers general GMP principles for finished products. Part II covers GMP for active pharmaceutical ingredients and is equivalent to ICH Q7. Annex 1 covers Sterile Medicinal Products and was revised effective August 2023. Members include agencies from Europe, North America, Asia Pacific, Africa, and Latin America. The FDA participates as a liaison, and the EMA coordinates EU member state participation.

Summary of Key PIC/S Requirements:

International arrangement between regulatory authorities
Develops harmonized GMP standards and guidance
PIC/S Guide PE 009 used by many authorities
Part I: General GMP principles for finished products
Part II: GMP for active pharmaceutical ingredients
Annex 1: Manufacture of Sterile Medicinal Products
Annex 1 revised effective August 2023
Section 8.123 for lyophilisers effective August 2024
Members include Europe, North America, Asia Pacific, Africa
FDA participates as liaison
EMA coordinates EU member state participation

Scope of Our GMP Auditing Services

Sterile Manufacturing Facilities

Sterile products carry the highest risk profile. Our sterile facility audits examine cleanroom design and environmental monitoring, aseptic technique and operator behavior, sterilization process validation, isolators and restricted access barrier systems, and container closure integrity testing. We evaluate whether cleanroom classification is appropriate, whether air flow patterns support contamination control, whether personnel and material flows avoid cross contamination, and whether environmental monitoring data supports conclusions about cleanroom state of control. Media fill design, execution, and deviation investigation are key audit areas.

Summary of Sterile Manufacturing Audit Areas:

Cleanroom design and classification
Air flow patterns and contamination control
Personnel and material flows
Environmental monitoring programs
Sampling point locations and frequency
Media selection and trending analysis
Aseptic technique and operator behavior
Media fill design and execution
Intervention types and incubation conditions
Moist heat sterilization validation
Dry heat sterilization validation
Radiation sterilization validation
Filtration sterilization validation
Isolator integrity testing
Glove leak testing
Transfer port operations
Container closure integrity testing

Non Sterile Manufacturing Facilities

Non sterile products carry risks around cross contamination, content uniformity, and microbial limits. Our audits cover facility flow and segregation, cleaning validation and changeover procedures, process validation and continued process verification, and water systems. We evaluate material and personnel flow design, dust control and containment for highly potent compounds, cleaning validation based on worst case conditions with toxicological data, changeover procedure execution, process validation approach, continued process verification, annual product quality review, and purified water, water for injection, and clean steam system design, operation, monitoring, and validation.

Summary of Non Sterile Manufacturing Audit Areas:

Facility flow and segregation
Dust control and containment
Cleaning validation based on worst case
Residue limit calculations with toxicological data
Changeover procedure execution
Process validation approach
Continued process verification
Annual product quality review
Purified water system design and monitoring
Water for injection system design and monitoring
Clean steam system design and monitoring

Contract Manufacturing Organizations

When you outsource manufacturing, you outsource the work but never the responsibility. We audit CMOs on your behalf to verify they meet your standards. Our reviews cover quality agreements and implementation, change control notification and approval, deviation and complaint handling, batch record review and release timelines, capacity and business continuity, and subcontractor and raw material supplier oversight.

Summary of CMO Audit Areas:

Quality agreements and implementation
Change control notification and approval
Deviation and complaint handling
Investigation depth and root cause analysis
CAPA effectiveness
Batch record completeness
Batch record review timelines
Release documentation
Capacity to meet demand
Technical capability for products
Business continuity planning
Subcontractor oversight
Raw material supplier oversight

Quality Systems and Validation

A manufacturing facility is only as strong as the quality system that supports it. We audit your quality management system against global regulator expectations. Key areas include documentation control, deviation management, change control, training, self inspection, supplier management, validation, and data integrity.

Summary of Quality System Audit Areas:

Documentation control and version management
Approval workflows and retention
Deviation investigation depth
Root cause analysis quality
CAPA effectiveness
Change control impact assessment
Regulatory filing triggers
Training curriculum design
Training effectiveness checks
Self inspection frequency and scope
Supplier qualification and monitoring
Validation DQ, IQ, OQ, PQ
Continued process verification
Data integrity audit trails
Access controls
ALCOA plus principles

Batch Release and Regulatory Inspection Readiness

We audit your batch release processes and inspection readiness. This includes release specifications, stability program, annual product quality review, and inspection readiness systems. We can conduct mock inspections that simulate the tone and pressure of a real health authority inspection.

Summary of Batch Release and Inspection Readiness Areas:

Release specifications review
Stability program assessment
Annual product quality review
Inspection readiness systems
Mock inspections simulating real inspections
Team preparation under realistic conditions

Audit Types We Provide

Internal GMP Audits

Internal audits, also called self inspections, verify compliance and identify improvement opportunities. We can conduct these audits on your behalf or train your team to perform them effectively. Internal audits cover all aspects of your quality system and manufacturing operations, typically conducted annually with more frequent audits for high risk areas.

Summary of Internal GMP Audits:

Conducted by your organization to verify compliance
Cover all aspects of quality system
Cover all manufacturing operations
Typically conducted annually
Higher frequency for high risk areas
Identify improvement opportunities
Can be conducted on your behalf
Training available for your team

Supplier and Vendor GMP Audits

Supplier audits verify that your raw material, component, and service providers meet GMP requirements. We audit API manufacturers, excipient suppliers, primary packaging manufacturers, and contract service providers. Audits are conducted before qualification, periodically during the supplier relationship, and when significant changes occur. We evaluate supplier quality systems, manufacturing controls, documentation practices, and data integrity.

Summary of Supplier and Vendor GMP Audits:

Verify raw material providers meet GMP requirements
Verify component providers meet GMP requirements
Verify service providers meet GMP habits
Audit API manufacturers
Audit excipient suppliers
Audit primary packaging manufacturers
Conducted before qualification
Conducted periodically during relationship
Conducted when significant changes occur
Evaluate supplier quality systems
Evaluate manufacturing controls
Evaluate documentation practices
Evaluate data integrity

Contract Manufacturing Organization Audits

When you outsource manufacturing, you outsource the work but never the responsibility. We audit CMOs on your behalf to verify they meet your standards. Our CMO audits assess quality agreements and implementation, change control notification and approval, deviation and complaint handling, batch record review and release timelines, and capacity and business continuity planning.

Summary of CMO Audits:

Verify CMOs meet your standards
Assess quality agreements and implementation
Review change control notification
Review change control approval processes
Evaluate deviation handling
Evaluate complaint handling
Review batch record review timelines
Review release timelines
Assess capacity and business continuity
Assess technical capability

Pre Approval Inspection Readiness Audits

Pre Approval Inspections are conducted by regulatory authorities before approving new products, new facilities, or major changes. We conduct mock Pre Approval Inspections that simulate the actual inspection experience. Our auditors review your facilities, systems, and documentation as an inspector would, and identify gaps that could lead to inspection findings or delays.

Summary of Pre Approval Inspection Readiness Audits:

Mock Pre Approval Inspections
Simulate actual inspection experience
Review facilities as inspector would
Review systems as inspector would
Review documentation as inspector would
Identify gaps before inspection
Prevent findings and delays
Prepare team for inspection

For Cause Audits

For cause audits are triggered by specific events such as product quality complaints, adverse event reports, regulatory observations, or significant deviations. We conduct these audits to investigate root causes, assess the extent of the issue, and recommend corrective and preventive actions.

Summary of For Cause Audits:

Triggered by product quality complaints
Triggered by adverse event reports
Triggered by regulatory observations
Triggered by significant deviations
Investigate root causes
Assess extent of issue
Recommend corrective actions
Recommend preventive actions

Follow Up and CAPA Verification Audits

After an audit identifies findings, corrective and preventive actions must be implemented and verified. We conduct follow up audits to verify that CAPAs have been effectively implemented and that the issues have been resolved.

Summary of Follow Up and CAPA Verification Audits:

Verify CAPAs have been implemented
Verify CAPAs are effective
Confirm issues have been resolved
Provide closure documentation
Prevent recurrence of issues

Mock Regulatory Inspections

We conduct mock inspections that simulate the tone and pressure of a real health authority inspection. These inspections prepare your team for the actual inspection experience and identify gaps before the regulator does. Mock inspections cover all aspects of your operations and documentation, with realistic questioning and document review.

Summary of Mock Regulatory Inspections:

Simulate tone and pressure of real inspection
Prepare team for actual inspection
Identify gaps before regulator
Cover all operations and documentation
Realistic questioning
Realistic document review
Practice under realistic conditions

Who We Work With and Our Partners

Clients We Serve

We work with a diverse range of clients across the life sciences industry, including pharmaceutical manufacturers, biotechnology companies, medical device manufacturers, contract manufacturing organizations, contract research organizations, API manufacturers, packaging companies, distribution companies, regulatory authorities, and investment firms.

Summary of Clients We Serve:

Pharmaceutical manufacturers (branded, generic, specialty)
Biotechnology companies (clinical and commercial stage)
Medical device manufacturers (Class I, II, III)
Contract manufacturing organizations (CMOs, CDMOs)
Contract research organizations (CROs)
API manufacturers (chemical and biological)
Packaging companies (primary, secondary, tertiary)
Distribution companies (wholesalers, 3PLs, cold chain)
Regulatory authorities (national and regional)
Investment firms (due diligence)

Our Partners

We collaborate with a network of partners to deliver comprehensive services, including regulatory consultants, technical experts, legal advisors, training organizations, software vendors, industry associations, and translation services.

Summary of Our Partners:

Regulatory consultants for joint engagements
Technical experts for specialized support
Legal advisors for compliance support
Training organizations for certification
Software vendors for validation support
Industry associations for benchmarking
Translation services for multilingual documentation

Our GMP Audit Process

We follow a structured process that keeps you informed at every stage and ensures the final report is useful, defensible, and actionable.

Phase	Activities	Output
Planning	Scope definition, standard selection, document review, agenda agreement	Audit plan and pre audit questionnaire
Opening meeting	Introductions, scope confirmation, logistics, confidentiality	Attendance record and confirmed schedule
Fieldwork	Facility tour, interviews, document review, sample tracing	Working notes and prelim observations
Closing meeting	Summary of findings, classification discussion, next steps	Draft findings list
Reporting	Final report with risk ranking and CAPA recommendations	Formal audit report
Follow up	CAPA review, effectiveness check, closure verification	Closure letter or re audit

Summary of GMP Audit Process:

Planning phase: scope, standards, document review
Opening meeting: introductions, scope confirmation
Fieldwork: facility tour, interviews, document review
Closing meeting: findings summary, classification
Reporting: final report with risk ranking
Follow up: CAPA review and closure verification

Why Choose GxP Cellators for GMP Auditing

Global reach with regional expertise across North America, Europe, Asia Pacific, Africa, and Latin America
Risk based audit programs tailored to your products and markets
Auditors with regulatory inspection and industry quality experience
Coverage of FDA, EMA, Health Canada, MHRA, WHO, and PIC/S GMP frameworks
Clear, prioritized reports written in plain business language
Practical remediation guidance that your team can actually implement
Complete confidentiality and conflict of interest management

Summary of Why Choose GxP Cellators:

Global reach with regional expertise
Risk based audit programs
Auditors with regulatory and industry experience
Coverage of FDA, EMA, Health Canada, MHRA, WHO, PIC/S
Clear, prioritized reports
Practical remediation guidance
Complete confidentiality

Partner With Us for Your Next GMP Audit

Whether you are preparing for a regulatory inspection, qualifying a new contract manufacturer, or strengthening your enterprise quality system, our GMP auditing team is ready to support you. Reach out to us to discuss your project requirements. Your inquiry will be handled with complete confidentiality and a prompt response.

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Source: GxP Cellators GxP Auditing page