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 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 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 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 the requirements of technical audits.
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- Initiating any change by originating change control request.
- Identifying need and procurement of new machines and equipments.
- 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 equipments 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.
- Co-ordination 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 equipments 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 on line SAP entries.
- Maintaining equipments 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
REVISION HISTORY
Nil
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2 Comments
Dear Mr. Mubarak Patel , Is it possible to have your whatsup number; Interested in your SOP's posted - some not all. Unable to print the SOP. Can you extend your support.
ReplyDeleteKindly communicate through email. patel.mubarak2@gmail.com
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