As the cosmetic industry continues to develop more advanced technologies to support their products, organizations must fully demonstrate the integrity they claim exists behind their science. When companies are producing both cosmetic and drug products within the same R&D department, what exactly does regulatory compliance and data integrity in cosmetics look like and how can it be achieved within the R&D community?
Compliance can be evaluated for a laboratory based on three main categories: procedures, instruments, and methods. Each category requires the use of controlled documents to ensure safe and effective operations in the R&D department, with the additional ongoing responsibility for employees to update and maintain those documents. Most importantly, however, employees must be trained on how to produce and utilize effective documents, and how to implement a training curriculum for all impacted employees that is consistently documented, tracked, and executed across the department. While this may seem daunting, almost all information can be easily documented if your organization has standardized processes. Challenges in implementing data integrity in cosmetics can arise if an organization’s R&D department is fragmented and siloed, executing laboratory processes differently or to different standards across groups, or even scientist to scientist within the same group. With the right experience in process mapping and document reviews, inclusive of all impacted groups, processes can be enhanced, and harmonization can be achieved across R&D.
How do you define what processes need controlled documents? Simply ask yourself – does the process support a regulated product/drug, product claim, or product specification? If you answered yes, a procedure should be documented that is well-defined and in accordance with ALCOA+ standards (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) and controlled via a document control system. Some examples of areas of control include laboratory documentation, receipt of samples, testing of samples, chain of custody, and disposal of samples.
In addition, methods must be validated to ensure repeatability, if they are not compendial methods. Method transfer procedures should be implemented for external laboratory testing. Scientists should be trained to execute methods and training must be properly documented. All procedures and methods should be managed with version control to document changes to processes and methods in the document control system.
Data Integrity in Cosmetics
It is important to consider the intended use of collected data and instruments when determining data integrity activities, since significant requirement differences may exist. Equipment used under Good Laboratory Practices (GLP) must be appropriately maintained, documented, and calibrated, though no computer software validation is required. When following Good Clinical Practices (GCP), equipment need only conduct studies safely and properly with no required software validation. The most stringent requirements exist for Manufacturing (GMP), which requires all equipment be qualified before use by execution of the 3Qs – Installation, Operational, and Performance Qualifications (IQ, OQ, PQ). Additionally, GMP requires calibration of all equipment and validation of test methods prior to use with any validated computer software. For an organization this means that equipment/instruments will have different levels of documentation and data integrity requirements. In general, if the equipment or instrument is used to generate a measurement or for substantiation of a claim, there should be calibration prior to use, routine calibration, and standardization prior to the measurement. The activities should all be well documented in either an electronic or paper logbook.
The first step in assessing your current level of data integrity is to map all processes, including controlled documents, unofficial documents, and undocumented processes. It is important to focus on the actual as-is processes rather than how they are supposed to be executed. This honest assessment of the current state allows for a more effective gap analysis to identify deficiencies, harmonization opportunities, and overall compliance improvements. It is recommended that this assessment be executed across all logically related groups to ensure cohesiveness, with the goal of the effort to improve harmonization within the processes and with globally standardized requirements. It is difficult to accomplish this if assessments are done on different timelines without an understanding of the holistic goal.
After completing this initial assessment, existing procedures can begin to be edited, and new documents can be developed and reviewed with SMEs. It is important to invest in training your personnel to write and manage controlled documents, as there is a learning curve to using compliant language, accurately documenting a process, and ensuring ALCOA+ and other regulating guidelines are met by the document. If your organization has no SOPs, or weak and non-compliant documents, the training and harmonization will be key before writing documents to ensure scientists and managers understand their responsibility to document processes and manage them in controlled document systems.
Sustaining data integrity in cosmetics can be just as challenging as its implementation. It is an ongoing, long-term capability that benefits from early identification of key resources within each R&D group who will be responsible for leading SMEs through the SOP development process. Communication across groups is also important in order to maintain an organized trajectory and stay aligned. Implementing data integrity will affect members of an organization at all levels so clear and constant communication can only strengthen change management within the organization.
In order to assess your current level of data integrity in cosmetics and implement new compliant processes, Clarkston has developed a methodology to help standardize this change in your organization. Clarkston can provide training for your personnel regarding how to write and maintain controlled documents. To assist with equipment assessments, Clarkston has developed a tiering system that can be utilized by an organization to determine the different levels of compliance required. Clarkston’s methodology for assessing your current level of data integrity and implementing new compliant processes is a tested approach that will help jump-start and sustain this change within your organization.
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Contributions by George Adams, Charlotte O’Halloran and Rob Wojtowicz.