SOP for Responsibilities of the Production Department

OBJECTIVE

To lay down the procedure to specify the responsibilities of the production department.

SCOPE

This SOP describes the functions and responsibilities of the production department.

RESPONSIBILITY

Execution: Operator

Checking: Production Pharmacist & Above

ACCOUNTABILITY

HOD-Production/ Assigned Designee

PROCEDURE

Functions of the production department

• Carry out production activities as per the production plan.
• Maintain online documentation related to production activities like BMRs, BPRs, log books and daily records.
• Qualification of production equipment and participation in validation activities.

Responsibilities of production

• Verification of Raw material/packaging material during dispensing as per BOM and receipt of raw materials and packaging materials as per BMR and BPR from the warehouse.
• Manufacturing and packaging of tablets/capsules as per BMR and BPR.
• To maintain documentation such as URS, DQ, IQ, OQ, PQ and validation protocols with reports.
• To check the quality system in the production department.
• To prepare standard operating procedures, equipment master list and equipment qualification plan.
• Review of MFRs, BMRs, BPRs, SOPs, and formats.
• Check deviations jointly with Quality Assurance.
• Evaluation and investigation of all market complaints and necessary corrective and preventive actions jointly with Quality Assurance.
• Training of personnel and evaluation of training given.
• To comply with the requirements of technical audits.

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• Initiating any change by originating change control requests.
• Identifying the need and procurement of new machines and equipment.
• Associating with contract giver during process validation and scale-up of new products.
• To check artworks of packaging materials and layout of packaging change parts.

• Check drawings of tablet tooling and to order tooling as per approved drawings.
• Resource identification (upgradation of existing equipment and manpower).
• Shift scheduling and leave sanctioning of production personnel.
• To comply the requirements of the safety audit.
• Interaction with warehouse/quality control for material availability/release of raw materials and packaging materials, semi-finished and finished goods.
• Coordination with engineering / external agencies for maintenance/machine breakdown/modification/calibration.
• Maintaining harmonious relations with staff and workmen.
• Control on scrap going out of the department.
• Proper allocation of manpower.
• Proper segregation of material, labeling and identification, area cleaning, and disinfection.
• Ensure cleanliness of hard-to-clean parts of equipment during cleaning for product changeover (level II cleaning) and also to ensure level I cleaning between batch to batch of the same product.
• Preventive maintenance and calibration according to schedule.
• Check on production yields and reconciliation at various stages of manufacturing.
• To ensure online SAP entries.
• Maintaining equipment and area cleanliness.

• To assure batch uniformity and integrity of drug products through written procedures followed by in-process controls and tests of each batch.
• To monitor outputs and to validate the performance of manufacturing processes.
• Compliance with cGMP norms.

ABBREVIATIONS

SOP: Standard Operating Procedure

BMR: Batch Manufacturing Record

Q.A.: Quality Assurance

HOD: Head of The Department

ANNEXURE

Nil

REVISION HISTORY

Nil

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