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  1. #1
    Validation Guru
    Join Date
    Oct 2010
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    Copenhagen,Denmark
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    Default Will we move ahead or not?

    There are crtitical issues regarding the Batch Manufacturing records that are paper based.

    - Take longer time than expected to create for a new product that has to be launched.
    -Take a longer time for a new facility to get started with new product materials.
    -Paper usage is a cumburesom procedure in sterile facilities, Biotech facilities and also where containments are important.Since paper is a cellulose based material they harbour large about of bacteria and generate great bioburden.
    -Expensive for sterilizing the papers that can be used in sterile areas. Need to validate such procedures with strict SAL before actually working in sterile areas (Autoclavable papers are expensive than normal papers)
    -Approval of paper based system is conventionally longer.
    -Approval and giving an extension sheets if manufactring takes longer time than usual process scenario.
    -At time it gives a scope for a wrong issuance.
    -A paper based system will prove a bigger headache during audits.(Internal, External and Regulatory audits). Not all papers present at one place. People need to run in shop floor and collect papers.
    -No security for such manufacturing instructions.
    -Takes a larger space and security when they are archived.
    - Errors and re-works take a longer time and will delay production.
    -Most of time paper based BMRs do not comply with GxP obligations.
    -Cannot be effectively managed for uploading into an ANDA submissions before a larger time on re-working takes place.
    -Signatures are crucial and paper based systems soon will become questionable.
    -Training issues to use and carry from one place to another.

    Did the industry learn any thing from these above mentioned problems and mooving ahead to Electronic based BMR's?

    Its time to think.
    Durga Prasad

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