Continuous improvement involving changes in processes, ingredients, and branding requires proper change management documentation by manufacturers in order to maintain compliance. Updated and complete ingredient lists must be included on product packaging furthering the necessity for efficient document control. Product safety can be demonstrated using supplier audits which examine incoming raw materials. Internal audits can further substantiate product safety by reviewing the product, process, facilities, and laboratory controls at various stages during the production process. Key equipment efficiency and performance can also be assessed through benchmark comparisons and scheduled calibrations and maintenance.
Pilgrim Software has created a platform of fully integrated, web-based compliance solutions that ensures compliance with cosmetic industry regulations and enables companies to substantiate product safety. Built on industry best practices and more than a decade of domain expertise, Pilgrim Software’s Risk, Compliance & Quality Management Platform offers a powerful, fully integrated solution for internal/external audits, nonconformance management, customer complaints, document management and SOP enforcement, employee qualification and certification, supplier quality, and equipment management.
Cosmetics manufacturers cater to a market with consumer expenditures exceeding $35 billion annually. Manufacturers are responsible for substantiating the safety of their products and ingredients while maintaining compliance with regulations. Recent product recalls due to contamination and usage of non-permitted color additives have heightened industry and consumer awareness concerning product safety. Company growth is adversely affected by recalls of hazardous or defective products or misbranded products.
Pilgrim's 21 CFR Part 11-compliant solutions help Cosmetics manufacturers:
- Reduce the cost of compliance while ensuring industry regulations are being fully met
- Effectively catalog ingredients, process, or branding change management
- Enforce SOP training, policies, and procedures while verifying employee education and training
- Maintain comprehensive document control for labeling and packaging and manufacturing and control procedures
- Establish an efficient, closed-loop system for receiving, processing, tracking, and solving customer complaints along with voluntary participation in filing Cosmetic Product Experience Reports
- Monitor suppliers and incoming materials to ensure conformance with appropriate standards
- Facilitate internal audits for self-preservation, facility standards, and laboratory controls
- Schedule recurrent calibrations and maintenance for key equipment preservation
- Manage nonconformances and implement preventative actions
- Enhance high-level enterprise-wide oversights and reduce management liability
White Paper - Cosmetics Manufacturing