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Writing & Executing a Software Validation Protocol: Plain and Simple

Writing & Executing a Software Validation Protocol: Plain and Simple


This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results.

While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims , experienced folks will likely find nuggets to help improve their efforts.



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  1. #1
    Validation Guru
    Join Date
    Oct 2010
    Location
    Kalundborg,Denmark
    Posts
    1,713

    Default New price-control policy fears in India

    The Indian government has announced plans to exercise stricter control over drug pricing in its domestic pharmaceutical market. Based on the proposed policy, at least 400 essential drugs will come under the fold of the National List of Essential Medicines (NLEM), thereby increasing the government's current control of 20% to approximately 70%. The new pricing method is meant to replace the current Drug Price Policy Control (DPCO) 95, which stipulates that drugs recording company turnover of Rs1 Cr to Rs4 Cr (1 Crore = 10,000,000 million rupees), under various criteria, and products that held market share above a 50% in the category, are brought under price control.

    Under the system, 74 bulk drugs and 1577 of their formulations have come under government purview as a result. Industry players and bodies such as the World Health Organization (WHO) are not in favor of the proposed drug policy. WHO representatives commented in a statement that the government's proposed method of drawing drug data has failed to "take into account of discounts, rebates and bundling deals." The data collection has also failed to provide pricing transparency and led to national abnormalities whereby high volume drugs are priced higher in India compared with neighboring countries, such as Sri Lanka.
    Durga Prasad
    Internal Consultant,Aseptic Process-NNE Pharmaplan
    www.nnepharmaplan.com
    Denmark

  2. #2
    Validation Expert
    Join Date
    Mar 2012
    Location
    Hyderabad
    Posts
    116

    Default

    Nice information sir.
    Small correction...
    1 crore = 10 million rupees / 10,000,000 rupees

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