
August 28, 2025
Why MI Experts Can Reduce Operational Burden for Pharma Companies
Discover how partnering with MI experts at ProPharma can reduce operational burdens, enhance compliance, and improve efficiency for pharmaceutical companies.
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.
Our GxP compliance team supports a complete suite of cGMP consulting options ranging from proactive to reactive needs.
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.).
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.
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 |
Audits, declarations, MIA Support |
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.
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.
Thorough preparation including document review and audit plan development. Following client provided procedures or through ProPharma’s established process.
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.
Our default auditing approach is to identify and evaluate the impact of potential compliance risks and potential areas of concern.
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.
Post audit, whether it is administrative, compliance adequacy review, or direct remediation support, ProPharma’s team can support your firm’s needs upon request.
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:
Evaluation of quality control and assurance processes.
Evaluation of quality control and assurance processes.
Read LessExamination of manufacturing practices, process controls, and batch documentation.
Examination of manufacturing practices, process controls, and batch documentation.
Read LessInspection of physical facilities and equipment maintenance programs.
Inspection of physical facilities and equipment maintenance programs.
Read LessAssessment of staff qualifications, training programs, and competency records.
Assessment of staff qualifications, training programs, and competency records.
Read LessReview of supplier qualification processes and material handling procedures.
Review of supplier qualification processes and material handling procedures.
Read LessProPharma’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.
FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation
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.
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.
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