1.0 OBJECTIVE
To lay down the procedure to specify the responsibilities of the production department.2.0 SCOPE
This SOP describes the functions and responsibilities of the production department.3.0 RESPONSIBILITY
3.1 Execution: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production/ Assigned Designee5.0 PROCEDURE
5.1 Functions of the production department
5.1.1 Carry out production activities as per production plan.5.1.2 Maintain online documentation related to production activities like BMRs, BPRs, log books and daily records.
5.1.3 Qualification of production equipment and participation in validation activities.
5.2 Responsibilities of production
5.2.1 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 ware house.5.2.2 Manufacturing and packaging of tablets / capsules as per BMR and BPR.
5.2.3 To maintain documentation such as URS, DQ, IQ, OQ, PQ and validation protocols with reports.
5.2.4 To check quality system in the production department.
5.2.5 To prepare standard operating procedures, equipment master list and equipment qualification plan.
5.2.6 Review of MFRs, BMRs, BPRs, SOPs and formats.
5.2.7 Check deviations jointly with Quality Assurance.
5.2.8 Evaluation and investigation of all market complaints and necessary corrective and preventive actions jointly with Quality Assurance.
5.2.9 Training of personnel and evaluation of training given.
5.2.10 To comply the requirements of technical audits.
5.2.11 Initiating any change by originating change control request.
5.2.12 Identifying need and procurement of new machines and equipments.
5.2.13 Associating with contract giver during process validation and scale up of new products.
5.2.14 To check artworks of packaging materials and layout of packaging change parts.
5.2.15 Check drawings of tablet tooling and to order tooling as per approved drawings.
5.2.16 Resource identification (upgradation of existing equipments and manpower).
5.2.17 Shift scheduling and leave sanctioning of production personnel.
5.2.18 To comply the requirements of the safety audit.
5.2.19 Interaction with warehouse / quality control for material availability / release of raw materials and packaging materials, semi finished and finished goods.
5.2.20 Co-ordination with engineering / external agencies for maintenance / machine breakdown / modification / calibration.
5.2.21 Maintaining harmonious relations with staff and workmen.
5.2.22 Control on scrap going out of the department.
5.2.23 Proper allocation of manpower.
5.2.24 Proper segregation of material, labeling and identification, area cleaning and disinfection.
5.2.25 Ensure cleanliness of hard to clean parts of equipments during cleaning for product-changeover (level II cleaning) and also to ensure level I cleaning between batch to batch of the same product.
5.2.26 Preventive maintenance and calibration according to schedule.
5.2.27 Check on production yields and reconciliation at various stages of manufacturing.
5.2.28 To ensure on line SAP entries.
5.2.29 Maintaining equipments and area cleanliness.
5.2.30 To assure batch uniformity and integrity of drug products through written procedures followed by in process controls and tests of each batch.
5.2.31 To monitor outputs and to validate the performance of manufacturing processes.
5.2.32 Compliance with cGMP norms.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
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