GMP Audit & GMP Consulting

ProPharma specializes in delivering comprehensive current Good Manufacturing Practice (cGMP) Audits and GMP Consulting services, designed to ensure compliance with regulatory standards and optimize manufacturing processes. With extensive worldwide expertise in the pharmaceutical, biotechnology, medical device, advanced therapy, and other healthcare industries, our consulting experts are committed to helping our clients maintain the highest levels of compliance, quality, and efficiency.

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Proactive  ⇔  Reactive

Our GxP compliance team supports a complete suite of cGMP consulting options ranging from proactive to reactive needs.

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Preventative

  • GMP Vendor Qualification
  • GMP and QMS Gap Analysis
  • Mock PAI / BLI Readiness
  • Internal GMP audit
  • QMS Building / Revision
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Maintenance

  • Maintenance GMP vendor audit
  • GMP Desktop / Checklist assessments
Compliance

Remedial

  • cGMP consulting services
  • For-Cause GMP Audits
  • Health Authority Response
  • Observation, 483, Consent Decree support.

GxP Audit Experience

ProPharma’s Global Auditing Program has conducted 1,000s of Audits for hundreds of global companies, across all GxP’s and phases. With offices and quality & compliance consultants located all over the world, ProPharma offers the availability to execute audits in different GxP areas on a global basis with diverse language skills, creating efficiencies in both time and money. Our large team of qualified auditors have a breadth of expertise across the entire development and regulatory spectrum (GMP, GCP, GLP, GCLP, GPV, ISO-13485, CSV, Data Integrity, etc.).

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GMP Audit Coordination Team

Our Audit Coordinators make your role easier, they provide facilitation and management of audit logistics, periodic progress meetings, timelines, and completion of deliverables between client/sponsor, auditor, and auditee.

The ProPharma Coordination team is connected to our network of Subject Matter Expert Compliance Consultants who provide technical support and guidance for compliance processes, peer review of deliverables and outputs as well as access to the entire catalogue of ProPharma’s services, forming our Global Auditing Team.

Our Global Auditing Team brings unparalleled collaboration, consultation, and right-sized compliance options to your GMP audit needs with a broad compliance reach.

GxP Compliance Reach

Popular Compliance Focus’

Sampling of Commonly Audited Compliance Standards

Pharmaceuticals, Raw Materials, Components, Packaging

21 CFR 210/211, EudraLex Volume 4, ICH Q1-14, Annex 1, ISO 9001

Biologics

21 CFR 211, 21 CFR 610, ICH Q5

Medical Devices

21 CFR 820 / ISO 13485 / (EU MDR) 745/2017

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P)

21 CFR 211, 21 CFR 1271

Compounding Pharmacies

USP <795>, USP <797>, 21 CFR 211

Active Pharmaceutical Ingredients (API)

21 CFR 210/211 ICH Q7, Annex 1

Cosmetic Products

ISO 22716 Cosmetics, FDA 21 CFR 700/701- MOCRA 2022

Computer Systems and Software / Digital IT / IS

21 CFR 11, GAMP 5, Annex 11

Excipients

USP <1078>, IPEC-PQG GMP Guide

Laboratories – GMP

GMP, ICH Quality Standards

Positron Emission Tomography (PET) Drugs

21 CFR 212, Eudralex 4, Annex 3

Dietary Supplements

21 CFR 111

Third-Party Logistics (3PL)

USP <1083>, WHO Annex 5 & 9, GDP 2013/C 343/01

Qualified Person (QP, QPPV) / Responsible Person (RP)

Audits, declarations, MIA Support 

ProPharma's GMP Audit Strategies

propharma-gmp-audit-services
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With respect to GMP Audits

We follow standardized practices relevant to local Health Authorities applicable to the individual client, sponsor, and/or auditee or are flexible to design a focused or for-cause audit specific to a direct client compliance need.

ProPharma’s Standard Scope and Methodology

Our GMP Auditing service was developed, and the process has been optimized over the years, which our customers find to be compliant, thorough, and efficient.

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Coordination & Preparation

  • Coordination Setup
  • Auditor Briefing Meeting
  • Agenda/Audit Plan
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Audit Execution

  • On-site or Virtual
  • Audit Conduct
  • Close Out Meetings
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Post Audit

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Pre-Audit Planning

Pre-Audit Planning

Pharmacovigilance

On-Site and Remote Audits

On-Site and Remote Audits

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Risk Assessment

Risk Assessment

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Report and Recommendations

Report and Recommendations

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Corrective and Preventative Action

Corrective and Preventative Action

Pre-Audit Planning

Thorough preparation including document review and audit plan development. Following client provided procedures or through ProPharma’s established process.

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On-Site and Remote Audits

Detailed compliance audits of facilities, equipment, processes, and documentation to assess compliance with GMP standards may be conducted in person or remotely. Our Audit Coordination Team can even assist with remote auditing technologies.

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Risk Assessment

Our default auditing approach is to identify and evaluate the impact of potential compliance risks and potential areas of concern.

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Report and Recommendations

As a standard audit output deliverable, audits are documented in full narrative comprehensive audit reports with actionable recommendations for addressing deficiencies and enhancing compliance. Alternate formats such as compliance checklist or matrices, or client provided templates are available.

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Corrective and Preventative Action

Post audit, whether it is administrative, compliance adequacy review, or direct remediation support, ProPharma’s team can support your firm’s needs upon request.

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Our auditors are knowledgeable, inquisitive, friendly, and collaborative. Auditors are assigned on a per audit basis, based on how their background experiences and expertise are aligned to the audit scope and project timing. ProPharma’s team is adaptive and flexible to each client’s needs. Key areas of GMP Audit focus are:

Key Areas of Focus During GMP Audits

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Quality Management Systems

Evaluation of quality control and assurance processes.

Quality Management Systems

Evaluation of quality control and assurance processes.

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Production Processes

Examination of manufacturing practices, process controls, and batch documentation.

Production Processes

Examination of manufacturing practices, process controls, and batch documentation.

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Facility and Equipment

Inspection of physical facilities and equipment maintenance programs.

Facility and Equipment

Inspection of physical facilities and equipment maintenance programs.

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Personnel Training

Assessment of staff qualifications, training programs, and competency records.

Personnel Training

Assessment of staff qualifications, training programs, and competency records.

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Supply Chain Management

Review of supplier qualification processes and material handling procedures.

Supply Chain Management

Review of supplier qualification processes and material handling procedures.

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ProPharma’s GMP Consulting Services

ProPharma’s cGMP consulting experts deliver tailored Quality System compliance solutions to our clients. We specialize in guiding pharmaceutical, device, biologics, and targeted therapies companies through the complexities of health authority requirements, ensuring that their processes meet stringent quality expectations. With our expert team of compliance consultants, you can confidently navigate the evolving landscape of GMP regulations, ultimately enhancing quality, safety, and efficacy.

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Consulting Services Offered

  • Quality Compliance: Guidance on meeting FDA, EMA, MHRA, and other international health authority requirements.
  • Quality System Development: Assistance in evaluating / assessing current stated and developing and implementing robust quality management systems.
  • Remediation Support: Support in addressing regulatory findings, including CAPA (Corrective and Preventive Action) planning and implementation.

GMP Consulting Services

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Quality Management Systems

  • Implementation, Remediation, and Maintenance - EMEA/MHRA/FDA - Pharma and Medical Device / Diagnostics
  • eQMS - Dot Compliance

Quality Management Systems

  • Implementation, Remediation, and Maintenance - EMEA/MHRA/FDA - Pharma and Medical Device / Diagnostics
  • eQMS - Dot Compliance
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Quality Assurance

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Quality Assurance

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Pre-Approval Inspection and Auditing

Pre-Approval Inspection and Auditing

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Remediation

FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation

Remediation

FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation

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Quality Control

  • EM and QC Program Development, Analysis Testing, Method Validation

Quality Control

  • EM and QC Program Development, Analysis Testing, Method Validation
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Additional GMP Audits & Consulting Services

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Additional GMP Audits & Consulting Services

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GMP Consulting Approach

  • Assessment and Analysis: In-depth analysis of current practices and identification of improvement opportunities. 
  • Strategic Planning: Development of tailored strategies to enhance compliance and operational efficiency. 
  • Implementation Support: Hands-on assistance with the implementation of recommended changes and ongoing support to ensure sustained improvements. 
  • Project & Program Management: direction and monitoring of milestone deliverables and project progression: 
  • Performance Monitoring: Assistance with vendor management, compliance oversight, and auditing to monitor compliance. 
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Our GMP Auditing Expertise:

Our Consulting team is composed of seasoned professionals with years of experience in GMP environments and best practices. Coupling deep understanding of the expectations and challenges of manufacturing in regulated environments, we ensure our clients receive the highest level of service and outcome.

Benefits of Partnering with Us

  • Enhanced Compliance: Achieve and “right-sized” compliance with relevant GMP regulations aligned with your company’s unique quality processes and business requirements.
  • Improved Efficiency: Optimize quality processes for better productivity and cost savings.
  • Risk Mitigation: Identify and mitigate compliance risks to prevent costly regulatory actions.
  • Knowledge Transfer: Empower your team with the knowledge and skills needed to sustain high standards of quality and compliance.
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ProPharma GMP Consulting Services

By partnering with ProPharma, you can be confident in your ability to meet regulatory requirements in your operations. Our commitment to quality and customer satisfaction is central to everything we do, ensuring that you receive the best possible support and outcomes.

News & Insights

FDA Releases Final ICH M13A Guidance Document

December 10, 2024

FDA Releases Final ICH M13A Guidance Document

FDA recommendations for conducting BE studies, efficiency improvements in global drug development, and how ProPharma can assist with your regulatory needs.

The Evolving Landscape of Quality Management Systems in the Life Sciences Industry

December 9, 2024

The Evolving Landscape of Quality Management Systems in the Life Sciences Industry

Discover the evolving landscape of Quality Management Systems in the life sciences industry and how to navigate modern regulatory challenges.

Pre-Approval Inspection (PAI) Readiness is Easy, Right?

December 5, 2024

Pre-Approval Inspection (PAI) Readiness is Easy, Right?

Ensure your product's success with ProPharma's expert guidance on PAI readiness, from remediation tasks to regulatory filing support.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Names Dawn Sherman Chief Executive Officer

September 30, 2024

ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Names Dawn Sherman Chief Executive Officer

September 30, 2024

ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

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ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Previous Award Arrow Next Award Arrow
FDA Releases Final ICH M13A Guidance Document

December 10, 2024

FDA Releases Final ICH M13A Guidance Document

FDA recommendations for conducting BE studies, efficiency improvements in global drug development, and how ProPharma can assist with your regulatory needs.

The Evolving Landscape of Quality Management Systems in the Life Sciences Industry

December 9, 2024

The Evolving Landscape of Quality Management Systems in the Life Sciences Industry

Discover the evolving landscape of Quality Management Systems in the life sciences industry and how to navigate modern regulatory challenges.

Pre-Approval Inspection (PAI) Readiness is Easy, Right?

December 5, 2024

Pre-Approval Inspection (PAI) Readiness is Easy, Right?

Ensure your product's success with ProPharma's expert guidance on PAI readiness, from remediation tasks to regulatory filing support.

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow