Showing all 7 results

  • Change Control System Procedure


    Serial numberVersion
    LDP195021.0
    Created dateLast Updated
    2021-02-02-
    Total PagesTotal Tests
    12 Pages14 Tests

     150

    Applicable to all departments and all their related systems and polices.This document descripes changes to all equipment, layouts, processes, facilities and utilities

  • Complaints Handling Procedure


    Serial numberVersion
    LDP195031.0
    Created dateLast Updated
    2021-02-03-
    Total PagesTotal Tests
    12 Pages18 Tests

     150

    This procedure covers all complaints received for all product.

  • Corrective Action Preventive Action Procedure


    Serial numberVersion
    LDP195011.0
    Created dateLast Updated
    2021-02-02-
    Total PagesTotal Tests
    14 Pages16 Tests

     150

    Corrective and preventive actions are needed and implemented to resolve problems that are encountered within the following: Internal Quality Audits and External Quality AuditsDeviations, Qualification, Calibration and Engineering Department, Customer Complaints¸ Recalls, etc.

  • GMP Training Procedure


    Serial numberVersion
    LDP195051.0
    Created dateLast Updated
    2021-02-05-
    Total PagesTotal Tests
    8 Pages16 Tests

     150

    To provide guidelines to train employee(s) on procedures related to their job performance and to ensure that key personnel involved in the distribution of medicinal products have the appropriate ability and training to guarantee that medicinal products are properly manufactured, stored and handled.

  • Handling of Deviations and Investigation Procedure


    Serial numberVersion
    LDP195001.0
    Created dateLast Updated
    2021-02-02-
    Total PagesTotal Tests
    14 Pages22 Tests

     100

    This procedure covers all unplanned and planned deviations which violate essential GMP rules and affect the quality of products, regulatory and/or operation process.

  • Handling of Recall Procedure


    Serial numberVersion
    LDP195041.0
    Created dateLast Updated
    2021-02-04-
    Total PagesTotal Tests
    16 Pages28 Tests

     150

    This procedure covers all distributed products in all countries. The procedure defines the initiation of the process, collection of the product, verification of recalled products, notification to regulatory authorities and follow up on effectiveness of the recall.

  • Risk Assessment and Risk Management System


    Serial numberVersion
    LDP195061.0
    Created dateLast Updated
    2021-02-06-
    Total PagesTotal Tests
    15 Pages46 Tests

     150

    The purpose of the guidance system is to provide tools on how to conduct risk assessment and management.

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