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The World Health Organization (WHO) has established guidelines for BMRs to ensure consistency, quality, and safety across the global pharmaceuticalindustry. By understanding and implementing these guidelines, manufacturers can play a vital role in protecting public health and maintaining the integrity of the pharmaceuticalindustry.
Additional findings included concerns with respect to document control, recordsmanagement, and lack of compliance with Standard Operating Procedures (SOPs). In addition, SOPs did not align with specified requirements and did not have a standardized format.
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