Are you struggling with the validation of Quality Control (QC) methods for your drug products? Outsourcing this process to a contract QC laboratory may be the solution you need. In this blog post, we explore six reasons why outsourcing ICH QC method validation can benefit your company.
6 reasons to outsource your QC method validation
1. Expertise
Outsourcing ICH QC method validation for drug products provides access to a team of experts with extensive experience in method validation, including knowledge of regulatory requirements, best practices, and potential pitfalls.
2. Cost savings
Validating QC methods in-house can be costly, requiring investment in equipment and resources. Outsourcing can be a cost-effective solution, especially for small or medium-sized companies, allowing them to calculate these costs upfront.
3. Time to market
Validation of QC methods can be a time-consuming process, taking several months. Outsourcing can speed up the process, allowing companies to bring their products to market faster.
4. Access to specialized equipment
Method validation requires access to specialized equipment and facilities. Outsourcing to a contract QC Laboratory can provide access to these resources without the need for investment in expensive equipment.
5. Risk reduction
Validating QC methods is a critical step in the drug development process, and errors or deficiencies can have significant consequences. Outsourcing to a qualified QC Laboratory can help mitigate risk by ensuring that validation is conducted according to regulatory standards and best practices, reducing the risk of regulatory issues or product failures.
6. Focus on internal tasks
By outsourcing method validation activities to experts in those fields, you can free up valuable time and resources to focus on your core competencies and main tasks. This allows you to prioritize what you do best and maximize your productivity and efficiency.
Conclusion
From cost savings and time to market, to access to specialized equipment and risk reduction, outsourcing can provide access to a team of experts with extensive experience in method validation.
By doing so, you can focus on your core competencies and main tasks, while ensuring that the validation is conducted according to regulatory standards and best practices.
If you’re looking for support with QC method validation, Quercus Lab, part of the QbD group, can provide the expertise and resources you need. Please don’t hesitate to get in touch.