SOP FOR RESPONSIBILITY OF QA PERSON
PURPOSE: To lay down the responsibilities of the Quality Assurance Department.
SCOPE: This procedure is applicable to the Quality Assurance Department.
RESPONSIBILITY:
Preparation of SOP : Officer/ Sr. Officer
Checking and Review of the SOP : Executive/Sr. Executive
Approval of SOP : Head of Department/ Assistant Manger
Authorization of SOP : Head QA/Designee
Quality Assurance Manager
ACCOUNTABILITY: Head QA shall be accountable for this SOP.
PROCEDURE:
Responsibilities of Quality Assurance Department
Quality Assurance Department is responsible for quality system planning, implementation of cGMP in plant and maintains compliance of manufacturing activity with regulatory requirements.
Quality Assurance Department is responsible for preparation of validation plan, review current process and determine validation need, maintaining valid process and planning validation strategy.
The Quality Assurance Department shall approve the master production records like master formula records, batch manufacturing records and batch packaging records.
The Quality Assurance Department is responsible for reviewing production records to ensure that no errors have occurred, and if errors have occurred, that they have been fully investigated.
The Quality Assurance Department shall monitor all aspects of manufacturing, processing, and packaging and has the authority to stop any operation to ensure compliance with procedures.
The Quality Assurance Department shall routinely monitor all buildings and facilities to ensure that they are clean and maintained in an orderly state of repairs.
The Quality Assurance Department shall review any pertinent documentation, i.e. logs and records, to verify that procedures for sanitation and maintenance are being performed properly.
The Quality Assurance Department is responsible for issuance and control of batch manufacturing records and batch packaging records and control of documentation system.
Responsible for control on artwork at plant level.
The Quality Assurance Department is responsible for batch numbering system and assigning batch number to product.
The Quality Assurance Department is responsible for annual product quality review, trend analysis.
The Quality Assurance Department is responsible for control on non-conforming materials.
The system of quality assurance appropriate to the manufacture of pharmaceutical products shall ensure.
Adequate arrangements are made for manufacture, supply, and use of the correct starting and packaging materials.
Adequate controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.
The finished products are correctly processed and checked in accordance with established procedures.
To ensure that drug product manufactured at site is manufactured accordance to cGMP requirement and contain quality attributes i.e. SISPQ (Strength, Identity, Safety, Purity, and Quality) and complies as per specification submitted to regulatory at the time of marketing authorization.
To responsible to batch release for dispatch by ensuring that write product distributed to write location.
To evaluate the compliance with GMP in all aspects of production and quality control, concept of self-inspection shall be followed.
The program shall be designed to detect shortcomings in the implementation of current Good Manufacturing Practices and to recommend the necessary corrective actions. Implementation of corrective and preventive actions shall be monitored for its effectiveness
The Head Quality Assurance shall investigate all product complaints and records thereof shall be maintained.
The Quality Assurance Department shall approve and maintain copies of all protocols.
Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
The Quality Assurance Department has the authority to approve or reject all components, drug product containers and closures, in process materials, packaging materials, labeling and drug products.
The Quality Assurance Department is responsible to approve or reject any procedure or specification affecting the purity, quality, strength, or identity of the drug product.
The Quality Assurance Department shall investigate and determine the disposition of returned goods.
The Quality Assurance Department shall determine whether or not a drug product can be salvaged.
Quality Assurance personnel shall have access to production and warehouse areas for sampling and investigation, as appropriate.
The Quality Assurance Department is also responsible for failure investigations, approving / rejecting the change controls, deviations and discrepancies along with control on recalls.
REFERENCE:
SOP FOR SOP