Expert Analytical Method Development and Validation Services | Synergy Health Utrecht.
Synergy Health Utrecht offers analytical method development and validation services. These services cater to the pharmaceutical, medical device, and related industries. Analytical method development and validation are essential in drug development and manufacturing. Once a method is developed, it must be proven suitable for its intended use. A successful validation ensures the method is valid for its purpose.
What Is Analytical Method Development?
Analytical method development is a critical aspect of quality control. Poorly designed methods can complicate the validation process, increasing both time and cost. To address this, Synergy Health Utrecht employs systematic procedures that guide customers through every stage of method development, ensuring efficiency and reliability.
Our team specializes in developing analytical methods for drug products, APIs, excipients, healthcare products, cosmetics, and related industries. Robust and well-designed methods simplify the subsequent validation process, streamlining the overall workflow. Our cGMP laboratories are fully equipped to support both method development and validation according to the highest quality standards.
In alignment with ICH guidelines, it is mandatory that analytical methods used for stability testing are stability-indicating. A key component of method development is the forced degradation study, which is essential for developing these stability-indicating methods. These studies involve subjecting the product to stress conditions, including exposure to acid, base, peroxide, light and elevated temperatures.
Forced degradation studies are invaluable for understanding the stability of a product. They identify its susceptibility to hydrolysis, oxidation, photolysis, revealing degradation pathways and byproducts. This information is critical for determining the method’s specificity and, consequently, the product’s purity. By leveraging these insights, we ensure that our methods provide reliable and comprehensive stability data, meeting both regulatory and industry standards.
How We Conduct Method Validation
Once a method is developed, its suitability must be verified. At Synergy Health Utrecht, method validation is conducted in compliance with ICH guidelines. Before validation begins, a detailed protocol is prepared and shared with the customer for approval. This protocol outlines the scope, objectives, and procedures of the validation process, including a description of the analytical method, its purpose, the parameters to be validated, the acceptance criteria, and the experimental procedures.
The validation process assesses key parameters such as specificity and linearity. Additionally, we determine the limits of detection (LOD) and quantification (LOQ) to establish the smallest detectable and quantifiable amounts of the analyte. It also evaluates accuracy, precision, and robustness to ensure the method is reliable and reproducible. Once the protocol is approved, validation experiments are performed as outlined, and the results are documented in a detailed report, which is shared with the customer.
At every step, Synergy Health Utrecht ensures the validation process adheres to regulatory standards, delivering methods that are both reliable and compliant.
Cleaning Validations
Synergy Health Utrecht provides cleaning validation services for pharmaceutical products. Cleaning validations are an essential component of manufacturing, ensuring that no cross-contamination occurs during production or packaging.
These validations are closely linked to method validation, as they require the detection of trace levels of residues on manufacturing equipment. The analytical method used must be validated to ensure it is specific, accurate, and sensitive enough to quantify residue levels and confirm compliance with the acceptance criteria.
Cleaning validations play a crucial role in maintaining product safety and regulatory compliance.
Industries That Benefit From Method Development and Validation.
Method development and validation are widely applied across various sectors, including pharmaceuticals, cosmetics, food & feed, and medical devices. At Synergy Health Utrecht, we tailor our services to meet the unique requirements of each industry, ensuring precision and compliance with industry standards.
Analytical Method Transfer
Ensuring the quality of pharmaceuticals hinges on rigorous stability testing and effective storage solutions. At Synergy Health Utrecht, we offer a comprehensive suite of services that encompass every aspect of this critical process. From assessing the stability of active pharmaceutical ingredients (APIs) and excipients to evaluating finished formulations, our approach is thorough and meticulous. Utilizing both compendial and tailored methods guarantees that our results are accurate and reliable. Additionally, our state-of-the-art storage facilities are designed to maintain the integrity of pharmaceutical products. Synergy Health Utrecht is dedicated to upholding the safety and efficacy of pharmaceuticals through rigorous stability testing and optimal sample storage solutions.
Why Choose Synergy Health Utrecht?
Synergy Health Utrecht is your trusted partner for expert analytical method development and validation. We ensure every method meets strict regulatory standards while aligning perfectly with your unique requirements. From initial development to seamless method transfer, we support you at every stage of the process.
With state-of-the-art facilities and a team of highly experienced professionals, we deliver reliable, innovative solutions tailored to your needs. Choose Synergy Health Utrecht for precision, compliance, and the confidence that comes from working with industry-leading experts.
Contact Synergy Health Utrecht today for industry-leading analytical method development, validation, and cleaning validation services tailored to meet your unique requirements.