Raw Data recording in pharma

[Sunjay]

Hi Everyone

My question is for the raw data recording in the worksheet, in the regulated pharma company.

How much detail for the method should be given in the worksheet?

If the STP is available (or method is given in pharmacoepia), then do we require to write all the HPLC parameters/ Dissolution parameters (like wavelength, Flow rate, Inj Vol etc.) in the woksheet, as we are performing the analysis or can we give the referance as per STP number XYZ.

Morover, do we require to write the batch no/ make of all the solvents and chemicals used during the analysis like in mobile phase preparation/ dissolution media preparation etc., id number of all the equipments used.

I would like to know the standard prctice in the pharma and what will be the good practice to satisify the regulatory/ auditors.

Regards

[aldij]

good practice and satisfying auditors is not allways the same.

[Sunjay]

good practice and satisfying auditors is not allways the same.

Dear

This is not clear to me. Let us talk about satisfying the auditors first, because that will be our final goal.

Regards

[Alex Buske]

Sunjay,
The problem with your question is, that "worksheet" isn't defined. It is also not required by any authority.
The level below pharmacopoeias is left up to the companies. They decide on cheap/high risk or expensive/low risk approach.

[DR]

A regulated pharma lab would have a SOP manual. Therein lies the answer to each of your questions.

[Sunjay]

Dear All

For worksheet u can consider Lab Notebook (LNB).

Sir, i hav to write a SOP for this. So i would like to know / discuss how much detail should be there in the LNB.

Do we hae to write all the details/ method parameters in the LNB or not?

Please share experineces.

Regard

[Rob Burgess]

If you are using a fully validated listed method (that your company has a repository for) then for method details etc. entry into your lab notebook I would say "as per method ref." would suffice.

In most pharma companies your various methods should be listed individually with unique ref. numbers.

[MK]

one way to do it:

Create a SOP, logbook and a reference for each equipment, method and column. Fix all critical (and validated) parameters in the SOP (for example chromatographic parameters). By doing this you don't need to repeat writing down everything, you can just refer to SOP. Don't fix things that are not critical and may be changing in the near future. For example write: HPLC grade acetonitrile in the SOP and write down the manufacturer, product number and a lot number each time in the logbook.

Record each run/sequence, diagnostics and maintenance in the equipment log. Record all weighs, pH's, dilutions, equipments (like balances), solvents, reagents, lot numbers in the method log. Record number of injections, backpressures, plates and tailing in to column log.