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COMPANY GOVERNANCE
Our Governance Framework
McGuff Outsourcing Solutions (MOS) operates under a strong, multi-layered corporate governance structure designed to ensure compliance, integrity, and accountability throughout all operations. MOS is a DBA of McGuff Pharmaceuticals, Inc. (MPI), which is wholly owned by McGuff Company, Inc. (MCI).
Together, these organizations form the McGuff family of companies, bringing more than 50 years of experience in pharmaceutical manufacturing, distribution, and regulatory compliance.
Governance at MOS is built on the principles of transparency, ethical conduct, regulatory excellence, and continuous improvement.
Quality Oversight Structure
The Quality Unit remains independent and operates with full authority to:
- Review and approve procedures
- Review batch records
- Oversee investigations, deviations, and CAPAs
- Approve raw materials and components
- Authorize product release
The Quality Unit has direct oversight from MPI and MCI as required and maintains full compliance with cGMP and 503B outsourcing facility expectations.
Governance Principles
MOS follows a governance framework rooted in:
- Regulatory compliance with FDA, CA Board of Pharmacy, USP, and cGMP
- Quality-first decision making, prioritizing patient safety
- Transparent and auditable operations
- Continuous improvement through CAPA, training, and internal audits
- Clear separation of responsibilities between operations and quality
- Ethical business practices across all functions
These principles guide daily operations as well as long-term strategy.
Commitment to Ethical and Compliant Operations
MOS ensures that every manufactured product meets strict standards for quality, safety, and consistency.
Our governance model empowers employees to identify risks, communicate concerns, and act in the best interest of patients and healthcare providers.
Detailed Governance Structure
Explore our comprehensive organizational framework and operational standards
Corporate Structure & Oversight
McGuff Company, Inc. (MCI) Corporate Headquarters & Oversight Body
MCI provides strategic leadership and governance for the McGuff family of companies, including:
- Corporate policy and ethics
- Risk management
- Finance and accounting
- Human resources
- Information technology and cybersecurity
- Corporate-wide quality initiatives
MCI serves as the administrative backbone of MOS and MPI.
McGuff Pharmaceuticals, Inc. (MPI) (consists of two manufacturing sites) Facility Registrations
- FDA Drug Establishment Registration
- 503B Outsourcing Facility registration
- USP and cGMP compliance
State Board of Pharmacy Licensure
MOS is actively obtaining and maintaining licensure with all 50 U.S. State Boards of Pharmacy, the District of Columbia, and U.S. territories to support nationwide distribution. State licenses will be posted as they are approved.
Corporate Licensing
- McGuff Company, Inc. (MCI) provides corporate oversight, administration, and compliance support
- McGuff Pharmaceuticals, Inc. (MPI) holds all manufacturing-related regulatory licenses
MOS & MPI Operational Responsibilities
McGuff Outsourcing Solutions (MOS) 503B Outsourcing Facility Operations & Product Oversight
MOS operates under the regulatory framework of McGuff Pharmaceuticals, Inc. (MPI), the FDA-registered and licensed drug manufacturer. MOS is responsible for:
- Drug selection and portfolio planning
- Product development and formulation planning
- Raw material confirmation and qualification (in coordination with MPI)
- Pharmacist oversight of sterile manufacturing processes
- cGMP oversight related to order management and distribution
- Communication of product requirements to MPI
- Ensuring that customer, clinical, and regulatory needs are incorporated into product design
MOS provides the operational and clinical oversight needed to guide manufacturing and ensure products meet customer requirements, clinical standards, and regulatory expectations.
McGuff Pharmaceuticals, Inc. (MPI) FDA-Registered Manufacturing Operations
MPI conducts all licensed manufacturing activities on behalf of MOS and is responsible for:
- cGMP-compliant batch production
- Sterile filling, packaging, and labeling
- Quality testing and laboratory operations
- Environmental and facility monitoring
- Product release to MOS following full QA review
- Maintaining FDA, California Board of Pharmacy, and other regulatory compliance
MPI executes the validated, controlled manufacturing processes that support the MOS product line and ensures that all drug products meet established specifications before release.
Governance Components
1. Quality Unit Independence
QA and QC maintain full authority to approve or reject components, drug products, release decisions, and processes without influence from operations or administration.
2. Commitment to Customers
Executive leadership conducts annual management reviews covering:
- Quality system performance
- CAPA trends
- Environmental monitoring
- Audit results
- Complaints and deviations
- Risk assessments
- Training adequacy
3. Internal Audits
Regular audits assess compliance with:
- FDA 21 CFR Parts 210/211
- USP standards
- Quality system procedures
- Regulatory guidance
4. Supplier Qualification & Oversight
Suppliers—including high-risk categories—are audited, qualified, and monitored in accordance with MOS and MPI standards. High-risk suppliers are re-audited annually.
5. Risk Management Framework
Risk-based decision-making is embedded throughout manufacturing and quality processes, aligned with ICH Q9 principles.
6. Policies & Code of Conduct
Employees adhere to corporate policies governing:
- Ethics
- Confidentiality
- Conflicts of interest
- Workplace conduct
- Regulatory reporting obligations
7. Training & Competency
All personnel receive extensive training in:
- cGMP
- Aseptic technique
- Documentation practices
- Safety protocols
- Regulatory expectations
Training is documented, assessed, and periodically verified.
