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 OperatingProcedure (SOP) is to lay down the procedure for defining job responsibilities of individuals.
- Scope :
This SOP is applicable to all responsible persons of pharmaceuticalIndustry
- Responsibility:
Officer QA– shall prepare the SOP co-ordinationwith all respective departments shallbe responsible for Preparation of SOP.
ExecutiveQA / designee shall review the SOP,
Head Quality Assurance shall approvethe SOP.
- Procedure:
To maintain a satisfactory systemof QA and manufacturing of drugproduct, as per cGMP requirement.
Each department shall be providedwith defined responsibility to perform the task for manufacturing of the DrugProduct to meet cGMP requirement.
The duties of each department aredefined but not necessarily be limited to as follows.
Warehouse:
Preparation and review of theinstruction for describing the receipt, identification, quarantine, storage andhandling of raw materials/ Packing materials/ Finished product.
Receipt, identification,quarantine, storage and handling of material / product according to preapproved instructions.
Environmental monitoring of thearea as per predefined procedures.
Making sure that any deviation isreported and investigated properly.
Making sure that storage area iscleaned.
Inventory control
Production
Preparing and reviewing theinstructions for the production of products according to written procedures.
Producing products according topre-approved instructions.
Reviewing all production batchrecords and ensuring that are completed and signed.
Making sure that all productiondeviations are reported and evaluated and that critical deviations areinvestigated and conclusions are recorded.
Making sure those productionsfacilities are clean and disinfected when appropriate.
Making sure that the necessary calibrationsare performed and recorded in respective areas.
Making sure that the premises and equipmentare maintained and recorded in respective areas.
Making sure that validation protocols andreports 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 theinstruction for describing the procedure for preventive maintenance, breakdownmaintenance.
Evaluating any change inequipment, machinery.
Calibration of equipment andinstrument used in manufacturing.
Operation of all Utilities likeWater, HVAC, Boiler, Compressed Air etc.
Execution of Installation andOperational Qualification of equipment as per approved protocol.
Quality Control
Sampling/testing and release ofincoming, in process and finished product as per the laid down specificationsand standard testing procedures.
Release / Reject of raw material/ Packing Material/Finished Product.
Making sure that criticaldeviations are investigated and resolved.
Out of SpecificationInvestigation.
Preparation and Standardizationof volumetric solutions and reagents.
Inventory control of chemicals /Glassware / media etc.
Preparation and review of allSOP’s related to department, Specification and test procedures.
Initiation and review of anychange related to the department.
Preparation and execution ofvalidation protocol for method validation and Analyst validation.
Making sure that materials areappropriately tested and results are reported.
To conduct Stability Studies.
Calibration of instruments usedin the Laboratories.
Handling of Reference standardand Working standard and qualification of working standard.
Quality Assurance
To ensure that Quality systemsare maintained as per cGMP requirement.
Review of batch records andrelease of Finished Product.
Approval of all SOP’s, STP’s,Specifications and master processing records etc.
Making sure that all criticaldeviations are investigated and resolved.
To conduct Self Inspection and toconduct Vendor Evaluation.
Change Control review andApproval.
Review and Approval of allvalidation related activities.
Performing Product Quality review.
Handling and Investigation ofMarket Complaints and product recall.
Human Resource
To prepare procedure forpersonnel hygiene medical checkup, housekeeping.
Employee Welfare.
To coordinate for training to allemployees.
To conduct regular medicalcheckups and house keeping
The department head shall ensurethat adequate number of personnel with necessary qualification and experienceare provided to complete the departmental responsibility. Department Head shallprepare job responsibility of every employee working in their department andshall explain the same to employee.
- TRAINING:
As per Employee Training SOP
- DISTRIBUTION:
ANNEXURE:
Annexure-I : Format for Job Responsibility
- REFERENCES:
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