Cosmetic GMP Compliance with eQMS

The cosmetics industry operates in a tightly regulated environment where product safety, quality assurance, and transparency are essential. To meet these demands, manufacturers increasingly rely on Electronic Quality Management Systems (eQMS), which help streamline compliance with key standards such as ISO 22716:2007, the Modernization of Cosmetics Regulation Act (MoCRA), and the use of Electronic Batch Records (eBR).

Understanding GMP in Cosmetics

Good Manufacturing Practice (GMP) refers to a set of guidelines that ensure cosmetic products are consistently produced and controlled according to quality standards. These guidelines cover every aspect of production from raw material sourcing to packaging and distribution. Adhering to GMP minimizes risks such as contamination, mislabeling, and product defects, ultimately protecting consumers and ensuring product integrity.

Regulatory Framework: MoCRA and ISO 22716

In the United States, MoCRA (Modernization of Cosmetics Regulation Act), enacted in 2022, significantly expands the FDA’s oversight of cosmetics. It mandates facility registration, product listing, adverse event reporting, and safety substantiation. For example, a company producing hair care products must register its facility with the FDA and renew it biennially. Each product must be listed with ingredient details and manufacturing locations. If a consumer experiences a serious reaction—such as a burn from a facial peel—the manufacturer must report the event within 15 business days and retain records for six years. MoCRA also requires manufacturers to maintain documentation proving product safety, such as clinical data or toxicological assessments.

ISO 22716:2007 provides internationally recognized guidelines for GMP specific to cosmetics. It covers production, control, storage, and shipment. For instance, manufacturing facilities must be designed to prevent contamination, with controlled access and logical material flow. Equipment must be easy to clean and maintain, and calibration records must be kept to ensure accuracy. Personnel must be trained in GMP principles, and a dedicated quality unit must oversee batch approval. Adhering to ISO 22716 enhances product safety, facilitates global regulatory compliance, and improves operational efficiency.

Role of Electronic Batch Records (eBR)

Electronic Batch Records (eBR) digitize the documentation of the manufacturing process, replacing traditional paper-based records. In cosmetics manufacturing, eBRs track raw material usage, equipment settings, process parameters, and operator actions. For example, when producing a batch of facial serum, the eBR system records the exact quantities of ingredients used, the calibration status of mixing equipment, and the identity of the technician performing each step. If a deviation occurs—such as a temperature spike during emulsification—the system logs it and triggers a corrective action workflow. eBRs reduce human error, ensure data integrity, and provide real-time visibility into production. They facilitate traceability and audit readiness, which are essential for MoCRA and ISO 22716 compliance. In the event of an adverse reaction, manufacturers can quickly trace the affected batch and review its production history. eBRs also enhance operational efficiency by integrating with tablets, barcode scanners, and ERP platforms to automate label verification and inventory tracking.

Integrating eQMS for Comprehensive Compliance

An eQMS is a software solution that centralizes and automates quality management processes. It supports GMP compliance by managing documents, tracking training, handling deviations, managing corrective and preventive actions (CAPA), and conducting internal audits. By digitizing these processes, an eQMS enhances efficiency, reduces errors, and improves visibility into quality management activities.

For MoCRA compliance, an eQMS can be used to track timely adverse event reporting, maintain product safety substantiation, and facilitate FDA audits through inspection portals. To meet these document requirements for adverse event reporting, an eQMS with integrated documentation management can link complaints to specific batches, generate reports for regulatory submission, and manage product listings and ingredient disclosures.

For ISO 22716, an eQMS automates document control, training records, and audit management. Per this standard, equipment used in production must be easy to clean and maintain, and calibration records must be kept to ensure accuracy in measurements which is especially critical when mixing active ingredients. An eQMS make it easy to store these records and retrieve them in times of need.

When integrated with eBR systems, an eQMS enhances data integrity and operational efficiency, enabling manufacturers to respond quickly to material tracing, quality issues, and regulatory demands. For example, when producing a batch of facial serum, the EBR system records the exact quantities of hyaluronic acid and botanical extracts used, the calibration status of mixing equipment, and the identity of the technician performing each step. With EBRs, manufacturers can also instantly retrieve validated records, complete with electronic signatures and audit trails.

How PSC Software Can Help

The ACE platform offers a comprehensive, validated, and scalable eQMS solution for cosmetics manufacturers navigating the complexities of MoCRA and ISO 22716. With integrated inspection portal, eBR capabilities, real-time analytics, and pre-configured compliance workflows for document management and learning management, ACE empowers cosmetics organizations to be GMP ready.