SOPs for Elixers V 2.0

The purpose of this SOP is to describe the procedure for accurate and contamination-free dispensing of excipients used in oral liquid elixir formulations. The procedure ensures consistency, traceability, and regulatory compliance throughout the dispensing process.
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The purpose of this SOP is to define a standardized method for the accurate, safe, and contamination-free dispensing of active pharmaceutical ingredients (APIs) used in elixir formulations. This ensures compliance with cGMP and maintains the integrity and traceability of dispensed materials.
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The purpose of this SOP is to ensure that the identity and quantity of raw materials received for elixir manufacturing are verified thoroughly and accurately before dispensing or use. This verification helps prevent errors in manufacturing and ensures regulatory compliance.
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To define a standard procedure for the control, handling, labeling, and use of primary containers during the dispensing of raw materials in the Elixir Department, ensuring traceability and compliance with cGMP standards.
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To define the standard procedure for maintaining accurate, timely, and traceable records of raw material movement within the Elixir Department, ensuring transparency and compliance with GMP and audit requirements.
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To define the procedure for the safe, traceable, and compliant transfer of remaining or partially used raw materials to the quarantine area after dispensing in the Elixir Department, as per GMP requirements.
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To define a procedure for the safe and effective handling, containment, and disposal of raw material spillage in the dispensing area of the Elixir Department, ensuring safety of personnel and prevention of cross-contamination.
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To establish a controlled and hygienic entry and exit procedure for personnel entering and exiting the dispensing area of the Elixir Department, thereby minimizing the risk of contamination.
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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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