SOPs for Elixers V 2.0

To establish a standardized procedure for calibration of weighing balances used in the dispensing area of the Elixir Department to ensure consistent weighing accuracy and compliance with GMP, WHO, and ICH guidelines.
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To define the standard procedure for minimizing and controlling cross-contamination during the dispensing of raw materials for elixir manufacturing in compliance with GMP and safety standards.
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To establish a standard procedure for routine environmental monitoring of the dispensing area in the Elixir Department to ensure cleanliness, compliance with cGMP, and prevention of contamination during dispensing operations.
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To establish a systematic and validated procedure for cleaning the weighing balance used in the dispensing room after each use to prevent cross-contamination, ensure operational accuracy, and maintain compliance with GMP standards.
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To define a standardized procedure for reconciling raw materials after dispensing, ensuring accountability, traceability, and compliance with cGMP to avoid mix-ups, losses, or misappropriation of raw materials in elixir manufacturing.
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To define a standardized procedure for the identification, segregation, documentation, and disposal of rejected raw materials during dispensing operations in the Elixir Department, ensuring compliance with GMP and preventing mix-ups or contamination.
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To establish a standard and validated procedure for verifying the cleaning status of equipment, utensils, and dispensing areas after the completion of raw material dispensing operations in the Elixir Department, ensuring compliance with GMP and cross-contamination prevention.
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To outline the procedure for the selection, use, and verification of approved dispensing aids and equipment in the Elixir Department to ensure accuracy, prevent contamination, and maintain compliance with cGMP guidelines.
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To define the procedure for verifying raw materials prior to dispensing in order to ensure correct identity, quantity, status, and suitability for elixir manufacturing. This SOP ensures accuracy, traceability, and GMP compliance.
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To establish standard requirements and procedures for the appropriate selection, usage, and disposal of personal protective equipment (PPE) by all personnel entering and working in the dispensing room of the Elixir Department.
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