Analytical Method Development, Validation and Transfer
Cormica is a specialist CRO focused on problem solving and delivering high quality analytical and laboratory support. We offer an unrivalled breadth of analytical solutions, techniques and applications to the pharmaceuticals, medical device, advanced wound management, healthcare and agrochemicals sectors, amongst others.
Many of these sectors require the development and stage-appropriate validation of efficient, accurate, precise and robust analytical methods, to ensure their products are both efficacious and safe. Moreover, compliant method development and validation is essential to meet regulatory requirements. Cormica has over 30 years of experience in developing and validating high quality analytical methods.
The types of methods required, and the extent of validation necessary, vary through the development lifecycle, and also with the type of product. Figure 1 exemplifies this for a novel pharmaceutical API (new chemical entity, NCE).
| Development Stage | Discovery | Early Development | Candidate Nomination | GMP (Phase I & II) |
|---|---|---|---|---|
|
Analytical Development |
Fit-for-Purpose:
Generic
|
Fit-for-Purpose:
Bespoke
|
Bespoke Methods for Key Sample Attributes |
Sample-Specific Regulatory Compliant Methods |
|
Method Status |
Scientifically Sound |
Scientifically Sound, Robust & Repeatable |
Pre-Validation / Suitability Assessment |
Stage Appropriate Validation / Verification |
|
Method Types |
Purity & ID |
Key Impurities & Properties, Benchmarking |
For example, Solid Form Optimization; Powder Properties |
ICH / Ph Eur / USP Method Suites |
Cormica's Analytical Method Development
Using our extensive range of equipment, we develop and validate bespoke analytical methods to meet customer needs – encompassing the testing of everything from raw materials and pure active ingredients through unusual sample types, challenging formulations, and a wide range of finished product types. Similarly, client, regulatory, monograph or literature methods can be readily established and verified in-house at Cormica, via a documented method or technology transfer.
Adopting an approach which aligns with ICH Q14, our method development pathway focusses on a detailed understanding of both the intended use of the method and the nature of the sample (Analytical Target Profile (ATP)), and utilising this information to determine the appropriate sample presentation and instrument parameters. The Critical Method Attributes (CMA) are established, and the chosen methodology is demonstrated to be efficient, repeatable and robust.
Method Development Risk Assessment
“A systematic approach to development that begins with pre-defined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management”: Quality by Design
Method development risk assessment can be a formal or informal process depending on the complexity of the method. Whichever approach is adopted, the same factors must be considered:
Cormica's Analytical Method Validation & Transfer
Method validation / verification is undertaken against a defined protocol / study plan, pre-approved by the customer and Cormica quality assurance, the scope of which can be tailored to be stage appropriate for the development status of the product and for the source of the analytical method.
All standard validation parameters are included, as appropriate for the technique, the sample type, and the regulatory requirements, as per ICH Q2 (R2), SANCO 3030/99 Rev 5, relevant technique specific guidance, e.g. USP <232> / <233>, and in-house validation SOPs. A detailed validation / study report is shared with the customer for review.
and Robust Method
Pre-Validation
& Acceptance Criteria
ICH Q2(R2)
QC / QA / Client Approval
QC / QA Review
Update MOA
Method transfers can be undertaken with Cormica acting as the originating or receiving laboratory, as required. Transfer is undertaken against a defined protocol / study plan, pre-approved by the customer and Cormica quality assurance.
The approach undertaken can be tailored depending on the complexity of the method, the development stage of the product, and the extent of the validation exercise undertaken by the originating laboratory. Options include:
Comparative Testing
- One or more selected batches of material are analysed by the receiving laboratory in accordance with the test method, and the results are compared with the results obtained by the originating site for the same batches.
- The results obtained from both sites are demonstrated to be comparable, against pre-defined acceptance criteria.
Method Revalidation
- Specific validation elements are repeated at the receiving site to demonstrate that the method can meet the requirements for the intended analytical application.
- The extent of revalidation will vary depending on the application of the method and the level of information available regarding the original validation.
- Partial or full revalidation may be appropriate.
Co-Validation
- The receiving site participates in the execution of one or more elements of the validation being undertaken.
- The co-validation is typically led by the originating laboratory, who provide the validation protocol and generate the final report.
Applications
Validated / verified methods can be transferred to the customer or a third party, or can be utilised in-house at Cormica for applications including:
- QC Batch release testing
- QC Reference substance qualification
- ICH stability studies
- GLP 5 Batch analysis
- GLP Storage stability
- Regulatory submissions
- Cleaning validation / verification
- Occupational hygiene
Cormica Capabilities
- Method development, establishment, verification, and validation to GMP and GLP.
- Method transfer to and from customer laboratories; Third party transfers.
- Quantitative and Qualitative methods / Limit tests.
- Identification, Characters, Assay and Related Substances, Impurities, Properties / Product-Specific tests (Key Performance Indicators).
- API, Excipients, Raw materials, Formulations, Finished Products, Packaging.
- Compliance with ICH Q2 (R2), SANCO 3030/99 Rev 5, other relevant regulatory guidelines, Pharmacopeial methods, plus internal SOPs.
- Wide range of analytical techniques:
- Separation sciences
- Specialised, high-end physical characterisation
- Elemental analysis, Physico-chemical testing, Raw materials methods, Physical properties
- Click to view Analytical Equipment List