Method Development, Validation & Transfers
Ensuring the safety, quality, and efficacy of drug products is the cornerstone of pharmaceutical manufacturing. Method development, validation, and transfer are essential processes that play a pivotal role in achieving these objectives.
Why is Method Validation Important?
Method validation ensures that analytical methods are:
- Reliable and reproducible
- Capable of minimizing data errors
- Supportive of the manufacturing process integrity
This guarantees that:
- Drug products are tested accurately for composition, purity, and potency.
- Patients receive medications that meet necessary safety and quality standards.
Compliance with ICH Guidelines & USP Standards
UniLab ensures all methods comply with global regulatory expectations, including:
- USP (United States Pharmacopoeia) standards
- ICH (International Council for Harmonisation) guidelines
Our method validation parameters include:
- Accuracy and Recovery
- Precision and Specificity
- Linearity
- Limits of Detection (LOD) and Quantitation (LOQ)
- Robustness
- Forced Degradation Studies
UniLab’s Expertise in Method Development & Validation
At UniLab, we specialize in providing high-quality solutions for method development and validation, including:
- Assay testing
- Impurity profiling
- Dissolution studies
- Preservative efficacy testing
- Residual solvent analysis
- Cleaning validation
Our services are designed to be economical and efficient, allowing stability studies and product releases to proceed swiftly.
Key Features of UniLab’s Services:
- Development and validation of in-house methods tailored to client products.
- Method transfers to accommodate client-specific techniques and processes.
- Rapid and reliable validation processes to minimize delays.
The Benefits of Partnering with UniLab
- Cost-Effective Solutions: Tailored services at economical costs to support your business goals.
- Rapid Turnaround: Fast validation processes to keep your projects on schedule.
- Expert Guidance: Access to a team of skilled professionals with deep expertise in method development.
- End-to-End Support: From development to validation and transfer, we handle all aspects seamlessly.
UniLab’s Expertise in Method Transfer
The formal transfer of a test methodology is a required GMP process that qualifies a receiving laboratory to utilize a method that originated in a transferring laboratory. This process is intended to ensure and document that the method performs as intended within the receiving laboratory environment.
UniLab BioPharma Product Testing network of laboratories offers advantages over other contractors in providing ICH and USP-based protocol writing support, maintaining a large breadth of testing capabilities and capacity, and using the latest technologies to support the method transfer process.
Why Choose UniLab for Method Transfer Testing?
- We have dedicated writing staff available to work with our customers to generate compliant protocols following ICH guidelines and the USP, including USP <1220>.
- We have completed method transfers utilizing all available equipment/procedures for pharmaceutical products.
- We provide a quick turnaround time for the execution of the protocol and generation of the final report.
Types of Transfers
Our extensive experience allows us to work closely with our clients to determine the most appropriate strategy for an efficient transfer method. Our approach is based on regulatory guidance combined with a risk analysis. Transfer options typically include:
- Comparative Testing – This is the most common approach and requires testing homogeneous lots of material by the sending and receiving laboratories. The transfer protocol will stipulate the procedure details, the samples used, and the acceptance criteria.
- Receiving laboratories Testing – In cases where the transferring laboratory is unavailable for comparative testing. Under this option, a risk-based approach compares receiving laboratory results to sending laboratories certificate analysis.
- Transfer Waiver – A transfer may be omitted based on the experience of the receiving laboratory (current use of a procedure on another product, transfer of personnel, etc.) or the transfer procedure is in the USP-NF. Verification should apply in this case.
Recommendations for a Method Transfer Project
The degree of success for a method transfer is often proportionate to the collaboration between the client and UniLab. We work closely with all parties involved to provide an efficient, timely and cost-effective transfer:
- The client should provide a copy of the method and validation report.
- Both parties should build time into the project for feasibility (familiarization) to allow the receiving laboratory to gain familiarity with the new method(s) before executing the formal protocol.
- The transferring laboratory must work closely with the receiving laboratory and use their experience to develop a risk-based approach for the transfer.
