ispe gclp cop traceabilityrawdatapresentation
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7/27/2019 ISPE GCLP COP TraceabilityRawDataPresentation
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• 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
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• IMPORTANT
Hand written. Clarity and easy readability
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• 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
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• Each has to be traceable to national or international
References.
• Some Examples will clarify.
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• 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
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• 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.
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• 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.
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• 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.
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• 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
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• Reference substances and their documentation is a
separate topic by itself and an important, major
requirement by all the auditors.
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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.
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• 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.
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• 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
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• 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
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• Any questions?
• Thank you for your attention
ISPE India CGLP
Documentation
27th Feb. 2010
J.L.Sipahimalani
email:[email protected]