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SOP for General Condition of the Liquid Manufacturing and Filling Areas

OBJECTIVE
To ensure that the Liquids Manufacturing and Filling Area are kept clean and fit for condition.
To reduce the possible risks of product contamination from external and internal sources.

SCOPE
This procedure shall be applied in the liquids Manufacturing Area.

RESPONSIBILITY
  • It is the responsibility of each and every individual working in this area to follow the procedure fully.
  • It is the responsibility of the Production Supervisor to ensure that the procedure is followed fully by the Production Assistant.
  • The QA Microbiologist will be responsible ensuring that all personnel are fully following the procedure.

PROCEDURE
  • The Liquids Manufacturing and Filling area are restricted areas and therefore should only be accessed by authorized personnel only.
  • All Personnel working in this Area should fully follow the SOP on working requirements for personnel working in the Liquids Manufacturing Area.
  • Cleaning of the rooms should be carried out on daily basis and after each Batch.
  • All doors and windows should remain closed when dispensing and Manufacturing are in progress.
  • Sweeping or dusting should not be done during dispensing and manufacturing.
  • All equipments used in this area should be appropriately cleaned after each operation to avoid cross contamination and accumulation of dirt.
  • All balances and calculators used should be those that have been calibrated and verified to be fit for use by QA.
  • Only those materials to be used for that particular operation should be kept in the area and removed after the intended work is completed.
  • Equipments and other materials kept in the room should be properly kept and arranged to prevent them from harboring microorganisms.
  • Monitoring of the environment shall be done by the Microbiologist at defined intervals as per SOP (Environmental Monitoring of Controlled areas).

ABBREVIATIONS
SOP: Standard Operating Procedure
QA: Quality Assurance

REVISION HISTORY
Nil

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