SOP for Responsibilities of the Head of the Production Department

Here is SOP for Responsibilities of the Head of the Production Department for pharmaceutical company.

Objective: Clarify the job responsibilities of the Production Department Manager.

Scope: Job responsibilities of the Production Department Minister.

Duty: The Minister of Production shall perform his/her duties. The Deputy Factory Director of Production shall be responsible for supervising the implementation of his/her duties.


  1. Complete all production tasks assigned by the factory department on time and with good quality.
  2. Ensure that all production activities of our factory are carried out in accordance with the production management documents, and take responsibility for the entire production process and GMP management of the factory to ensure that the production quality meets the standards, and take responsibility for the quality of the produced products.
  3. Responsible for arranging production plans and approving plans for materials required for daily production.
  4. Develop and write production process specifications, production original records, production standard operating procedures, and various forms used for recording, which are reviewed by the quality management department and approved for implementation by the responsible person of the factory.
  5. Responsible for supervising and controlling the environment and process hygiene in the production area.
  6. Ensure that production operating instructions are strictly implemented, and be responsible for all consequences arising from failure to strictly implement production management documents or due to production management errors during the production process.
  7. Responsible for managing, assessing, and training personnel at all levels in the production department.
  8. Responsible for establishing a self-inspection system, monitoring the entire production process, and ensuring that the entire production process complies with GMP regulations.
  9. After the production of a production batch is completed, responsible for reviewing all original records and forms of the department, conducting material balance review, signing after review, and taking responsibility for the entire production process of the batch.
  10. Participate in the validation work of the department, responsible for formulating the work plan and implementation rules, and ensuring the smooth progress of each production validation work.
    Check the maintenance and upkeep of the factory and equipment, ensure good condition and normal operation, and approve production maintenance and various procurement plans.
  11. Immediately stop any production behavior that does not meet document requirements and report it to the company’s responsible person and notify relevant departments.
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