The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals.
- Objective :
The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals.
- Scope :
This SOP is applicable to all responsible persons of pharmaceutical Industry
- Responsibility:
Officer QA – shall prepare the SOP co-ordination with all respective departments shall be responsible for Preparation of SOP.
Executive QA / designee shall review the SOP,
Head Quality Assurance shall approve the SOP.
- Procedure:
To maintain a satisfactory system of QA and manufacturing of drug product, as per cGMP requirement.
Each department shall be provided with defined responsibility to perform the task for manufacturing of the Drug Product to meet cGMP requirement.
The duties of each department are defined but not necessarily be limited to as follows.
Warehouse:
Preparation and review of the instruction for describing the receipt, identification, quarantine, storage and handling of raw materials/ Packing materials/ Finished product.
Receipt, identification, quarantine, storage and handling of material / product according to pre approved instructions.
Environmental monitoring of the area as per predefined procedures.
Making sure that any deviation is reported and investigated properly.
Making sure that storage area is cleaned.
Inventory control
Production
Preparing and reviewing the instructions for the production of products according to written procedures.
Producing products according to pre-approved instructions.
Reviewing all production batch records and ensuring that are completed and signed.
Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and conclusions are recorded.
Making sure those productions facilities are clean and disinfected when appropriate.
Making sure that the necessary calibrations are performed and recorded in respective areas.
Making sure that the premises and equipment are maintained and recorded in respective areas.
Making sure that validation protocols and reports are prepared and reviewed.
Evaluation of proposed changes in product, process or equipment.
Making sure that new and when appropriate, modified facilities and equipment are qualified.
Engineering
Preparation and review of the instruction for describing the procedure for preventive maintenance, breakdown maintenance.
Evaluating any change in equipment, machinery.
Calibration of equipment and instrument used in manufacturing.
Operation of all Utilities like Water, HVAC, Boiler, Compressed Air etc.
Execution of Installation and Operational Qualification of equipment as per approved protocol.
Quality Control
Sampling/testing and release of incoming, in process and finished product as per the laid down specifications and standard testing procedures.
Release / Reject of raw material / Packing Material/Finished Product.
Making sure that critical deviations are investigated and resolved.
Out of Specification Investigation.
Preparation and Standardization of volumetric solutions and reagents.
Inventory control of chemicals / Glassware / media etc.
Preparation and review of all SOP’s related to department, Specification and test procedures.
Initiation and review of any change related to the department.
Preparation and execution of validation protocol for method validation and Analyst validation.
Making sure that materials are appropriately tested and results are reported.
To conduct Stability Studies.
Calibration of instruments used in the Laboratories.
Handling of Reference standard and Working standard and qualification of working standard.
Quality Assurance
To ensure that Quality systems are maintained as per cGMP requirement.
Review of batch records and release of Finished Product.
Approval of all SOP’s, STP’s, Specifications and master processing records etc.
Making sure that all critical deviations are investigated and resolved.
To conduct Self Inspection and to conduct Vendor Evaluation.
Change Control review and Approval.
Review and Approval of all validation related activities.
Performing Product Quality review.
Handling and Investigation of Market Complaints and product recall.
Human Resource
To prepare procedure for personnel hygiene medical checkup, housekeeping.
Employee Welfare.
To coordinate for training to all employees.
To conduct regular medical checkups and house keeping
The department head shall ensure that adequate number of personnel with necessary qualification and experience are provided to complete the departmental responsibility. Department Head shall prepare job responsibility of every employee working in their department and shall explain the same to employee.
- TRAINING:
As per Employee Training SOP
- DISTRIBUTION:
ANNEXURE:
Annexure-I : Format for Job Responsibility
- REFERENCES:
NiL