ISPE GCLP COP TraceabilityRawDataPresentation

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Strategic Planning Bonita Springs

• WHY TRACEABILITY

•Credibility of the raw data. Not just written withoutactually testing.

• Auditor’s requirement

• OOS results investigation

TRACEABILITY IN RAW DATA OF

ANALYTICAL RECORDS




• IMPORTANT

Hand written. Clarity and easy readability




• WHAT IS TRACEABILITY IN THIS CONTEXT?

• 1. Protocols

• 2. Lab Equipment

• 3. Reagents

• 4. Reference Substances

• 5. Nomenclature

• 6 . Observations and readings

• 7. Calculations

• 8. Results for the certificate in decimal point as per the limit




• Each has to be traceable to national or international

References.

• Some Examples will clarify.




• PROTOCOLS

• Generally the specifications, Methods of testing are in booksof standards like IP/BP/USP or developed by the manufacturer

as IN HOUSE.

• If In house, there should be reference no. the specificationwith traceability the development and validation of themethods of the tests

• There is a practice of issuing the sample by a authorizedperson to a qualified analyst for testing, in the raw data or aseparate register with time and date. This is to document thechain of custody of the sample




• With the sample work sheet to be provided with

adequate information of the document number

which will contain the details of the methods of

testing to be applied.

• There is a preference by some to enter the raw data

alongside the methods. Others prefer to useIndividual Analyst’s notebook.




• If USP/IP/BP. The actual quantities of the reagents

preparation and other details not in the official

monographs need to be included.

• Dates of authorization of the authorized person for

distribution, qualification by training evaluation of

the analyst for the relevant tests would add to thequality of the document.




• EQUIPMENT

• Equipment ID No. and calibration due date of each of

the equipment used have to be entered.

• MATERIALS

• Usually Reagents and reference substances are used.




• Reagents: If stock solutions are used, dates of preparation reference no. and use before dates,traceable to a register where further details like

prepared by, quantity prepared would be given.

• Reference substances: Have a identification no. anduse before date, Traceable to a register where thedetails of preparation of Working standards, log of usage and original reference substances detailswould be available




• Reference substances and their documentation is a

separate topic by itself and an important, major

requirement by all the auditors.




Orded at the time

• NOMENCLATURE

• Exactly as per the national or International specifications

• Eg Iron to be clarified Ferrous Sulphate, any other salt or Fe,with the exact chemical formula

•OBSERVATIONS AND READINGS

• To be recorded at the time of the tests.




• In TLC test: No relevant spot, slight or near the intensity of thelimit of the impurity spot, preferably a photograph or adiagram.

• Readings with the decimal points as on the instrument used.

• Calculations as traceable to the relevant specification.

• Results rounded up to the decimal point as per the limit.




• CHROMATOGRAMS

• Concentrations of the injected solutions

• Sequence wise number, time and date

• System suitability mentioned in the specification or

not , has to be carried out.

• Blanks or placebos




• RAW DATA

• Fully traceable or not?

• CERTIFICATE

• Duly signed, is the end product of the Q.C. activitiesand all the relevant data, like a batch record of amanufactured product, needs to be fully traceable




• Any questions?

• Thank you for your attention

ISPE India CGLP

Documentation

27th Feb. 2010

J.L.Sipahimalani

email:[email protected]

Documents

ISPE GCLP COP TraceabilityRawDataPresentation