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The World Health Organization (WHO) has established guidelines for BMRs to ensure consistency, quality, and safety across the global pharmaceuticalindustry. The Importance of Adhering to WHO Guidelines Adherence to WHO guidelines for BMRs is essential for ensuring the quality, safety, and efficacy of pharmaceutical products.
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. PDA Technical Report No.
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