The short answer is to document developmental runs and developmental summary in a GLP notebook (physical or electronic). Have an independent reviewer of the data and a summary with key findings and parameters. ICH doesn't force you into a specific way to document or report early development work. Each company also has its own standard operating procedures on what and how that needs to be handled, so check internally for that.

In practice, a development report is often needed. I have been a project lead for several approved FDA drug submissions, so below I will give you some extra details I have come to find for myself:

It's good practice to write development reports in the following cases:

1) You Develop Methods Meant to be Used in the Future in a Controlled Environment (cGMP-certified, DEA-inspected, ISO-certified, etc.) Because there is a progression of a method from the R&D group to the QC and commercial manufacturing groups, those groups (part of the stakeholders) may require written developmental summary to rely on (or reference) in their effort to evaluate the method applicability in such controlled environment. Some companies have series of phases in an analytical method life: Method Development, Method Qualification, Method Evaluation (QC will evaluate what specs need to be set for the method validation and do final fine-tuning), Method Validation. The validation group (or technical operation group) may have a checklist of items provided to them before they initiate some of this method progression work, which may include development summary report.

2) If You Execute Scientific Work as a Contract Organization:

For example, you are working in a CRO (contract research organization), CDMO (contract drug manufacturing organization), or CTO (contract testing organization). Depending on how your proposal/scope of work is set with the customer, often developmental work is paid by the customer and executed for their project-specific needs. This in turn makes the intellectual property (the analytical method) theirs to own. Related to this is the need for you to provide timely updates to the customer (one side of stakeholders) and assurance things are going well. Additionally, they may periodically send parties to audit your facility or may need to either carry out some of the work in-house or move to a different contract organization. This is why they will need some written developmental summary that contain sufficient details to satisfy the contract between you and them.

3) Legal Aspect for a For-Profit Organization

Sometimes companies have disputes over intellectual property (analytical methodology, synthesis routes, etc.). When brought into court, companies will need to provide evidence they came up with the invention on their own and will need to prove this with chronological data and reports.

4) Early Phase Drugs: If you manufacture Phase I drugs (pre-clinical), chances are you still haven’t done any process or method validations. There are also many unknowns at that phase. Running such drug files through FDA (because I work in the USA) often involves the agency probing into the developmental data more than generic drugs, for example, to have something support the proposed clinical claims because there still isn’t sufficient other historical data (either clinical or physico-chemical).

Yes, you can change your research interests by reflecting on what excites you, discussing it with your advisor, and familiarizing yourself with the new field. Networking and adjusting your research plan will also facilitate a smooth transition.

Maria Kravchenko,

You can prepare method development "SOP". Specify in the SOP about method development procedure and data shall be recorded in Laboratory note book (LNB). Report format shall be included in SOP for developed method.

Method development data is to be recorded in the laboratory notebook provided the final method report can be prepared for better tracking of documents. ICH Q2 is about definition and details given how to performed method validation and limits however ICH Q14 is supporting guidelines for method development considering Quality by Design(QbD).

In-short, yes, all method development data is to be documented in Laboratory note book(LNB) and final method report preparation.

Hopefully ,Clarified your doubts. If more question feel free to ask.