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The Modernization of Cosmetics Regulation Act (MoCRA) transforms cosmetic Good Manufacturing Practices (GMPs) from “nice-to-have” guidance into binding FDA requirements. Cosmetics manufacturers that move first will reduce compliance risk and avoid costly remediation. Partner with Performance Validation (PV) to get MoCRA-ready with evidence-based, audit-strong validation.
What Is MoCRA (+ Why It Matters)
MoCRA is the most significant update to U.S. cosmetic law in more than 80 years. It brings cosmetics closer to drug/device rigor by requiring:
- Mandatory GMPs for cosmetics manufacturing (previously voluntary)
- Facility registration & product listing with the FDA
- Safety substantiation & adverse event reporting with defined timelines
- Stronger enforcement, including inspection authority and recalls
As a cosmetics manufacturer, you will need qualified facilities, processes, and environmental controls, validated computerized systems, supplier oversight, and inspection-ready records that demonstrate your systems function as intended.
Performance Validation’s MoCRA Process:
INPUTS
URS
CLASSIFICATION & RISK
DR / DQ
C&Q TESTING & DOCUMENTATION
ACCEPTANCE & RELEASE
OPERATION
PERIODIC REVIEWEnd-to-End Validation Solutions to Simplify MoCRA Compliance
PV offers a full suite of solutions designed to help cosmetics manufacturers meet MoCRA’s GMP standards with confidence. Each service combines FDA-tested rigor with practical execution, bridging the gap between regulatory expectations and operational efficiency.
Commissioning, Qualification & Validation (CQV)
PV’s CQV programs establish documented evidence that your equipment, utilities, and facilities perform consistently and meet regulatory expectations. From developing Validation Master Plans (VMPs) and User Requirement Specifications (URS) to executing Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), PV ensures your manufacturing processes are both reliable and compliant. We also handle process and cleaning validation, as well as environmental monitoring program setup, so your operations remain controlled from the start.
Computerized Systems Validation (CSV)
As cosmetics companies adopt more digital systems for quality and production management, PV helps validate critical systems, including Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), Environmental and Building Management Systems (EMS/BMS), data historians, and electronic record-keeping tools. Our computer system validation (CSV) services ensure compliance with FDA 21 CFR Part 11 and ALCOA+ data integrity principles—verifying that every electronic record is accurate, secure, and traceable. Whether you’re using off-the-shelf platforms or custom-built tools, PV assures that your data systems can withstand regulatory scrutiny.
Computer Software Assurance (CSA)
PV applies a risk-based, evidence-driven approach to software validation aligned with the FDA’s computer software assurance (CSA) guidance. Instead of over-documenting, we focus on proving that automated or configurable tools function as intended and maintain data integrity. This approach saves time, reduces documentation burden, and accelerates implementation—all while ensuring your systems support MoCRA’s quality expectations.
Temperature Mapping
Environmental control is critical to product stability and quality. PV performs temperature mapping for warehouses, cold rooms, stability chambers, and transport vehicles, establishing temperature uniformity and validating alarm set-points. Our seasonal mapping and trend analysis help cosmetics manufacturers maintain precise storage conditions for sensitive ingredients and finished goods, thereby protecting product efficacy and shelf life.
Critical Airflow Visualization (CAV)
For higher-risk product lines, such as aseptic, ophthalmic, biotech, or preservative-free cosmetics, PV conducts airflow visualization studies to confirm proper laminar flow and effective contamination control. Our engineers conduct these tests scientifically, utilizing smoke studies and recovery testing where applicable, to verify that clean areas function as intended. As a result, you gain confidence that your critical environments consistently protect product quality.
Production Part Approval Process (PPAP)
PV adapts production part approval process (PPAP) methodologies for cosmetics packaging and critical components. We help suppliers demonstrate process capability, material consistency, and alignment with your quality system. This process strengthens supplier relationships, ensures traceable documentation, and supports effective change control — all of which are essential under MoCRA’s new supplier quality expectations
Digital Validation as a Service
Our digital validation services streamline compliance by moving validation activities into a centralized, digital environment. Using tool-agnostic platforms such as Valkit, PV builds digital trace matrices, audit trails, and report hierarchies that simplify evidence management. This modern approach eliminates manual bottlenecks, enhances collaboration, and ensures that all validation data is inspection-ready at any time.
Building Commissioning
Before equipment validation begins, PV ensures the facility itself performs as designed. We commission buildings to verify that environmental conditions support product quality and GMP compliance. Our process ensures stable performance across critical parameters like temperature, humidity, and air quality, establishing a foundation for successful qualification and production.
Cleanroom Services
For manufacturers producing sterile or microbiologically sensitive products, PV provides comprehensive cleanroom services. We design classification strategies, perform cleanroom qualification, and implement ongoing environmental monitoring programs. Our experts also train staff in proper gowning and aseptic behaviors, ensuring every aspect of your cleanroom — airflow, particle control, and personnel practices — supports MoCRA-compliant operations.
Uncover Compliance Gaps Before the FDA Does
Where do you stand with MoCRA compliance? If you’re unsure, now’s the time to take action. Our MoCRA Gap Assessment provides a clear, evidence-based view of your current compliance status and a practical roadmap to achieve audit readiness. PV’s experts review your facilities, processes, documentation, and digital systems against MoCRA and global GMP standards like ISO 22716. This allows us to identify risks, estimate the effort for compliance, and prioritize actions so you can focus where it matters most.
Your customized MoCRA Gap Assessment includes:
- Facility & Equipment Review: Evaluate whether utilities, environmental controls, and process equipment meet GMP expectations for design, installation, and qualification.
- Process & Documentation Audit: Examine SOPs, validation evidence, batch records, and change control processes to ensure traceability and inspection readiness.
- Supplier & Quality Systems Evaluation: Assess supplier qualification, raw material controls, and CAPA management for compliance with FDA expectations.
- Computerized Systems & Data Integrity Check: Review QMS, LIMS, and digital validation tools for 21 CFR Part 11 and ALCOA+ alignment.
- Action Plan for Readiness: Receive a detailed, prioritized report outlining what to fix, how to fix it, and where to start — complete with timelines, resource needs, and compliance milestones.
Our risk-based approach ensures that your validation efforts are targeted, efficient, and defensible when MoCRA enforcement begins.
Why Partner with PV for MoCRA Compliance?
When it comes to MoCRA compliance, experience and execution matter. PV brings decades of FDA-regulated expertise to the cosmetics industry, helping manufacturers establish rigorous, efficient, and inspection-ready compliance programs from the outset.
- FDA-Tested Rigor: Our validation packages consistently pass FDA and global audits because we understand what inspectors expect to see and how to provide documentation that withstands scrutiny.
- Right-Sized Approach: Your controls are scaled to product and process risk, focusing on evidence that matters; never validation for validation’s sake.
- End-to-End Delivery: Get CQV, CSV, CSA, environmental monitoring, temperature mapping, supplier qualification, and inspection readiness all under one roof.
- Digital Fluency: We provide digital validation and 21 CFR Part 11 know-how without locking you into a single platform.
- Faster Path to Compliant Launch: Sequenced work packages minimize downtime, avoid rework, and keep your project moving on schedule.
- Cosmetics-Ready Playbooks: Built on decades of pharmaceutical and medical device expertise, our frameworks are tailored for the specific compliance realities of MoCRA.
Let’s Build Your MoCRA-Ready Validation Program
MoCRA turns guidance into law. PV turns requirements into evidence you can defend. Together, we can develop a validation program that protects quality, accelerates launches, and passes an FDA inspection.
Frequently Asked Questions
What is MoCRA?
The Modernization of Cosmetics Regulation Act (MoCRA) turns voluntary Good Manufacturing Practices (GMPs) into mandatory, enforceable FDA requirements. MoCRA expands FDA oversight by requiring facility registration, product listing, safety substantiation, adverse event reporting, and GMP compliance. For cosmetics manufacturers, this means FDA inspections, documentation, and evidence-based validation are now mandatory.
When will MoCRA’s GMP requirements be enforced?
The FDA is expected to finalize cosmetic GMP regulations by late 2025, following draft guidance in 2024. While enforcement will likely include a short grace period, manufacturers are strongly encouraged to start preparing now, especially since validation and documentation take time to implement. PV can help you complete gap assessments and readiness activities well before enforcement begins.
How does MoCRA compare to GMP requirements in pharma and medical device manufacturing?
MoCRA requirements are less stringent than those for pharmaceuticals or medical devices. Still, they are modeled on many of the same GMP principles, including equipment qualification, process validation, environmental controls, and documentation of data integrity. PV brings decades of experience from FDA-regulated industries, applying the same rigor so that your systems and processes meet MoCRA expectations efficiently.
What types of systems and processes will need to be validated under MoCRA?
Under MoCRA, cosmetics manufacturers may need to validate equipment, facilities, utilities, and computerized systems that impact product quality or safety – for example, mixing tanks, purified water systems, or temperature-controlled storage.
What is a MoCRA gap assessment, and how can it help me prepare?
A MoCRA gap assessment identifies where your current quality systems, documentation, and processes fall short of upcoming GMP requirements. PV conducts a detailed audit of your operations, reviewing procedures, validation evidence, environmental monitoring, and supplier controls, to create a prioritized action plan. You will receive a roadmap to full compliance that’s efficient, practical, and tailored to your facility.
Do cosmetics manufacturers need cleanrooms or airflow testing under MoCRA?
Not all cosmetics facilities require cleanrooms, but those producing sterile, ophthalmic, preservative-free, or biotech-based products often do. In these cases, critical airflow visualization (CAV) and cleanroom qualification studies are crucial for controlling contamination and demonstrating environmental stability. PV conducts airflow visualization and recovery testing where appropriate, ensuring that clean areas perform as designed.
What is temperature mapping, and why is it important for MoCRA compliance?
Temperature mapping verifies that storage and transport environments maintain uniform, controlled conditions. Many cosmetic ingredients, such as natural oils, peptides, and botanicals, are temperature-sensitive and can degrade if stored improperly. PV conducts temperature mapping in warehouses, cold rooms, and transport vehicles, identifying hot or cold spots, validating alarm limits, and documenting evidence of control for regulators.
How does PV help with supplier qualification under MoCRA?
MoCRA requires manufacturers to ensure their suppliers and raw material providers meet GMP standards. PV performs supplier qualification audits to verify that your ingredient and packaging suppliers operate under compliant quality systems, ensuring your vendors are reputable, approved, and capable of meeting FDA and MoCRA requirements.
How can digital validation tools help my company comply with MoCRA?
Digital validation platforms simplify compliance by replacing manual, paper-based documentation with a secure, traceable, and easily auditable system. PV offers digital validation as a service, using tool-agnostic solutions to manage protocols, test data, and approvals in real time. This approach streamlines audits, reduces human error, and ensures your validation data is inspection-ready at all times.
What happens if my facility isn’t MoCRA-compliant in time?
Non-compliance with MoCRA could result in FDA Warning Letters, product recalls, or halted distribution. Beyond enforcement risk, failure to comply can delay product launches and damage brand reputation. PV helps cosmetics manufacturers achieve compliance proactively to reduce the likelihood of costly remediation and ensure continuous, compliant production.
How soon should I start preparing for MoCRA?
Start now. Establishing validation programs, supplier qualifications, and GMP documentation takes time. Waiting until the final rule is released in late 2025 could leave too little margin for implementation and testing. Starting early allows PV to help you build a phased readiness plan that spreads costs, reduces operational disruption, and ensures full compliance when enforcement begins.
