The cleaning validation is necessary to establish the consistency and uniformity by discussing practices that have been found acceptable. Cleaning validation (CV) is driven by regulatory expectations to ensure that residues from one product will not carry over and cross-contaminate the next product. Regulatory scrutiny is more rigorous in a multiproduct facility, compared with a single product establishment. Companies are usually cited, either for not having a sound cleaning validation, or not meeting the protocol acceptance criteria. Because failing a protocol acceptance criteria is considered a substantial regulatory risk, companies are forced to spend money and resources, even though there is minimal, or no product risk.
It is vital for a successful cleaning validation to have appropriate acceptance criteria. In developing the acceptance criteria, companies may adopt a conservative approach, either to prove that they have a sound cleaning validation program, or to ensure that field data (results) will reflect the acceptance criteria. The Food and Drug Administration's (FDA) guidance for determining residue limits is, that they must be logical (based on understanding of the process), practical, achievable, and verifiable. In validation, adequacy of each cleaning procedure requires demonstration that it can reliably and effectively remove, or reduce residues to an acceptable level, such that residues from the production of one product will not carry over in significant amounts to the next product. Companies today are faced with the challenge of reducing validation costs in an environment that demands increased compliance with current good manufacturing practices (cGMP). One should recognize that with cleaning validation, as with validation of other processes, there can be more than one way to validate a process. At the end, the test of any validation process is whether scientific data shows that the system consistently does as expected and produces a result that consistently meets predetermined specifications.
Cleaning validation involves documenting all procedures involved in the validation process, typically the cleaning validation process involves the following steps
- Validation Plan and Projects - Specifying the company policy on validation of the cleaning process, related to equipment, including ancillary.
- Risk Assessment (Author, review and approve).
- Authoring acceptance criteria protocols (Author, review and approve).
- Execution acceptance criteria protocols and summary report (Execute, review and approve).
- Management of Execution Deviations or OSS (out-of-specification) (Initiate, assess, review and approve).
- Revalidation and Periodic review plan.
The current cleaning validation approach, which relies on paper and manual systems, is time-consuming and inefficient, as documents are needlessly recreated and tedious manual tasks are performed on a routine basis.
ValGenesis maintains the entire cleaning validation process electronically through web interface. Life Science companies can replace tedious paper or manual base cleaning validation process with an electronic, automated validation lifecycle management system that supports the risk based approach and makes the cleaning validation process 100% electronic.
ValGenesis provides the following integrated functional modules to manage the entire cleaning validation process electronic.
To create, review and approve Validation Plan and Projects Specifying the company policy on validation of cleaning process related to equipment, including ancillary
To create, review, approve and manage requirements/critical quality attributes/ process parameters with risk levels and traceability matrices with risk assessment (Author, review and approve)
To create, review, approve and manage risk assessment, following Failure Modes Effects Analysis (FMEA).
To author, review and approve acceptance criteria protocols (Author, review and approve)
To perform electronic (paperless) or Manual execution of acceptance criteria protocols and summary report. Review and approve the executed protocols acceptance criteria protocols and summary report. Management of Execution Deviations or OSS (out-of-specification) (Initiate, assess, review and approve)
To create, review and approve periodic review schedules.
- A workflow based system, manages the entire cleaning validation process along with other required data and documents.
- Configurable and adaptable to a specific corporate environment.
- Create and reuse cleaning validation protocols within the software.
- Ability to specify acceptance criteria depending on development stage, assay type and compound type.
- Ability to assign pre-configured run sequence templates to develop a validation protocol.
- Fully controlled and compliant with regulatory requirements.
- Provides real-time cleaning validation status through KPI dashboard.
- Flexible, built in reporting tool.