Procedure for defining job responsibility
1.0 OBJECTIVE
1.1 To lay down the procedure for Defining Job Responsibilities.
2.0 SCOPE
2.1 This procedure applies to all the responsible persons in the all Departments
3.0 RESPONSIBILITY
3.1 Head – Concerned Department.
4.0 ACCOUNTABILITY
4.1 Assistant Manager – Quality Assurance Department.
5.0 PROCEDURE
5.1 To maintain a satisfactory system of Quality Assurance and manufacturing of Tablets & Capsules as per cGMP requirement. Total operation is divided into various functions, called as departments. Following are the departments.
5.1.1 Inventory Control.
5.1.2 Production.
5.1.3 Engineering.
5.1.4 Quality Control.
5.1.5 Quality Assurance.
5.1.6 Personnel & Administration.
5.2 Each department shall be provided with defined responsibility to perform the task for manufacturing of Tablets & Capsules to meet cGMP requirement.
5.3 The duties of each department are defined but not necessarily be limited to as follows.
5.3.1 Inventory Control
5.3.1.1 Preparation and review of the instruction for describing the receipt, identification, quarantine, storage and handling of raw materials/ Packing materials/ Finished product.
5.3.1.2 Receipt, identification, quarantine, storage and handling of material / product according to per-approved instructions.
5.3.1.3 Environmental monitoring of the area as per predefined procedures.
5.3.1.4 Making sure that any deviation is reported and investigated properly.
5.3.1.5 Making sure that storage area is cleaned.
5.3.1.6 Inventory control.
5.3.2 Operation
5.3.2.1 Preparing and reviewing the instructions for the production of products according to written procedures.
5.3.2.2 Producing products according to per-approved instructions.
5.3.2.3 Reviewing all production batch records and ensuring that are completed and signed.
5.3.2.4 Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and conclusions are recorded.
5.3.2.5 Making sure those productions facilities are clean and disinfected when appropriate.
5.3.2.6 Making sure that the necessary calibrations are performed and recorded in respective areas.
5.3.2.7 Making sure that the premises and equipment are maintained and recorded in respective areas.
5.3.2.8 Making sure that validation protocols and reports are prepared and reviewed.
5.3.2.9 Evaluation of proposed changes in product, process or equipment.
5.3.2.10 Making sure that new and when appropriate, modified facilities and equipment are qualified.
5.3.3 Engineering
5.3.3.1 Preparation and review of the instruction for describing the procedure for preventive maintenance, breakdown maintenance.
5.3.3.2 Evaluating any change in equipment, machinery.
5.3.3.3 Calibration of equipment and instrument used in manufacturing.
5.3.3.4 Operation of all Utilities like Water, HVAC, Boiler, Compressed Air etc.
5.3.3.5 Execution of Installation and Operational Qualification of equipment as per approved protocol.
5.3.4 Quality Control
5.3.4.1 Release / Reject of raw material / Packing Material/Finished Product.
5.3.4.2 In process Control of product quality.
5.3.4.3 Making sure that critical deviations are investigated and resolved.
5.3.4.4 Out of Specification Investigation.
5.3.4.5 Preparation and Standardization of volumetric solutions and reagents.
5.3.4.6 Inventory control of chemicals / Glass wares / media etc.
5.3.4.7 Preparation and review of all SOP’s related to department, Specification and test procedures.
5.3.4.8 Initiation and review of any change related to the department.
5.3.4.9 Preparation and execution of validation protocol for method validation and Analyst validation
5.3.4.10 Making sure that materials are appropriately tested and results are reported.
5.3.4.11 To conduct Stability Studies.
5.3.4.12 Calibration of instruments used in the Laboratories.
5.3.4.13 Handling of Reference standard and Working standard and qualification of working standard.
5.3.5 Quality Assurance
5.3.5.1 To ensure that Quality systems are maintained as per cGMP requirements.
5.3.5.2 Review of batch records and release of Finished Product.
5.3.5.3 Approval of all SOP’s, MOA’s, Specifications and master processing records etc.
5.3.5.4 Making sure that all critical deviations are investigated and resolved.
5.3.5.5 To conduct Self Inspection.
5.3.5.6 To conduct Vendor Evaluation.
5.3.5.7 Change Control review and Approval.
5.3.5.8 Review and Approval of all validation related activities.
5.3.5.9 Performing Product Quality review.
5.3.5.10 Handling and Investigation of Market Complaints and product recall.
5.3.6 Personnel and Administration
5.3.6.1 To prepare procedure for personnel hygiene medical checkup, House Keeping.
5.3.6.2 Employee Welfare.
5.3.6.3 To coordinate for training to all employees.
5.3.6.4 To conduct regular medical checkups and housekeeping.
5.3.6.5 The department head shall ensure that adequate number of personnel with necessary qualification and experience are provided to complete the departmental responsibility.
5.3.6.6 An Organizable for each department shall be prepared by department head.
5.3.6.7 The individual employee profile shall be prepared by Head of Department or his duty and approved by Head – QA in the format as per Format No.
6.0 TRAINING
6.1 Trainer: – Head Quality Assurance.
6.2 Trainee:- All concern department Head / Quality Assurance personnel.
6.3 Period:- One day or as per required.
7.0 DISTRIBUTION:
7.1 One set of Master copy and one set of Controlled copy submit the QA department.
8.0 ENCLOSURES
8.1 Format for Employee Job Profile and Format No.
9.0 ABBREVIATIONS
9.1 QAD : Quality Assurance.
9.2 SOP : Standard operation procedure.
9.3 CCR : Change Control Request.
9.4 cGMP : Current Good Manufacturing Practices.
9.5 HVAC : Heating Ventilation and Air Conditioning Systems.
9.6 STP : Standard Testing Procedure.
9.7 API : Active Pharmaceutical Ingredient.
9.8 MOC : Material of construction
9.9 QA : Quality Assurance
10.0 DOCUMENT CHANGE HISTORY
| Version | Reason for Revision | Effective Date |
| 00 | NEW SOP |
Format for Employee Job
| JOB PROFILE | |||
| NAME | DATE OF JOINING | ||
| DESIGNATION | DEPARTMENT | ||
| EDUCATIONAL QUALIFICATIONS | EXPERIENCE | ||
| EFFECTIVE DATE | REVISION NO. | ||
| JOB RESPONSIBILITIES | |||