1.0 PURPOSE:
2.0 SCOPE:
This SOP describes the functions and responsibilities of quality units at (Company name).
3.0 DEFINITIONS:
4.0 RESPONSIBILITY:
4.1 All personnel in Quality Unit shall carry out the activities as described in this procedure.
4.2 Head QA is responsible for the implementation / compliance of this procedure.
5.0 PROCEDURE:
5.1 Responsibilities of QA Department:
5.1.1 In process QA checks and Line Clearance:
5.1.1.1 To provide line clearance before start of activity such as dispensing of materials, starting of each manufacturing activities and packing of drug product.
5.1.1.2 To check and verify calculation of materials to be dispensed for manufacturing.
5.1.1.3 To conduct in process checks as per BMR/BPR and record results.
5.1.1.4 To monitor batch manufacturing process and report any non-conformances, deviations.
5.1.1.5 QA shall be responsible for sampling of in process materials, intermediates, finished products, control samples of FP, validation samples and stability samples. Collection of rinse/swab samples during cleaning validation/verification.
5.1.1.6 Ensure environmental conditions monitored and recorded during manufacturing.
5.1.1.7 Ensure that only materials meeting the defined quality criteria used in production.
5.1.1.8 The Quality Assurance Unit shall monitor all aspects of manufacturing, processing, and packaging and has the authority to stop any operation to ensure compliance with procedures delineated within this SOP.
5.1.1.9 The Quality Assurance Unit shall routinely monitor all buildings and facilities to ensure that they are clean and maintained in an orderly state of repairs.
5.1.1.10 Quality Assurance personnel shall have access to production and warehouse areas for sampling and investigation, as appropriate.
5.1.1.11 Conducting acceptable quality level (AQL) inspection for OSD and Injectable product.
5.1.2 Deviations, Incidents and Investigations:
5.1.2.1 QA is responsible to ensure that non-conforming work/deviations are reported, registered, investigated to establish root cause and documented in a timely manner.
5.1.2.2 Ensure timely closure of deviation reports and to prepare trend/summary reports.
5.1.3 Handling Market Complaints:
5.1.3.1 QA is responsible for registering the market complaints, investigation, documentation and timely response to complaint.
5.1.3.2 Where required, follow-up for complaint sample, sharing interim report is also the responsibility of QA.
5.1.3.3 QA is responsible for proper closure of complaints.
5.1.4 Failure Investigation:
5.1.4.1 QA is responsible for registering the Out of specification results/product failures, investigate and document.
5.1.4.2 Head QA is responsible to approve re-analysis/re-sampling, if required, based on investigation findings.
5.1.4.3 Ensure timely closure of investigation reports.
5.1.5 Field Alerts/Product Recalls:
5.1.5.1 To initiate Field alert and product recalls, where required due to product complaints, deviations, stability failures and any other situation which impacts product quality, safety and efficacy.
5.1.5.2 Investigate, establish root cause, take appropriate CAPA, and close the field alert/product recall. Performing mock recall activity.
5.1.6 Returned and Salvaged drugs:
5.1.6.1 The Quality Assurance Unit shall investigate and determine the disposition of returned goods.
5.1.6.2 The Quality Assurance Unit shall determine whether a drug product can be salvaged.
5.1.7 Corrective and Preventive actions:
5.1.7.1 QA shall ensure that corrective and preventive actions are proposed and taken, wherever required, to address deviations, market complaints, OOS/OOT results, product failures, observations from external audits i.e. either customer audit or regulatory inspections.
5.1.7.2 Responsible to ensure CAPA proposed are appropriate to root cause.
5.1.7.3 Ensure proposals and actions are timely documented and monitor for effectiveness of compliance to CAPA taken.
5.1.8 Training:
5.1.8.1 QA is responsible for training of new employees on quality system procedures.
5.1.8.2 QA is responsible for annual training for existing staff on quality system procedures.
5.1.8.3 QA is responsible for providing cGMP training to all employees.
5.1.9 Change Management:
5.1.9.1 Register change controls, evaluate the impact of change, identify affected departments, identify affected documents/activities and document in the change control forms.
5.1.9.2 Approve/Reject change controls, communicate to customer/MAH about the change, if required, follow up with responsible staff on status of actions identified and document the same.
5.1.9.3 QA shall verify for the impact after change implementation and close the change controls.
5.1.10 Site Master File, Validation Master Plan and Quality Manual:
5.1.10.1 QA is responsible for preparation, review/revision and approval of site master file, Validation master plan and Quality Manual.
5.1.10.2 Quality assurance unit is responsible for review of current process and determine validation need, maintaining valid process and planning validation strategy.
5.1.11 Preparation, Review and Approval of Documents and Reports:
5.1.11.1 Preparation, review and approval of SOPs related to quality assurance functions, periodic review and revision of SOPs prepared by QA.
5.1.11.2 Review and approval of SOPs related to all other departments.
5.1.11.3 Prepare and distribute SOP index of all the departments as per defined frequency.
5.1.11.4 Preparation, Review and Approval of BMR, BPR, Process validation protocols and reports Aseptic Process Simulation protocol and report, cleaning validation protocols and reports, hold time study protocols and reports. Review of cleaning procedure development reports.
5.1.11.5 Review and Approval of Qualification protocols and reports related to facility, utility, equipments and instruments.
5.1.11.6 Approval of Specifications, STPs, Method transfer protocols and reports.
5.1.11.7 Preparation and Approval of Stability protocols.
5.1.11.8 To review and approve the lay-outs related to facility, water system, HVAC system, pest control, man movement and material movement.
5.1.11.9 To review and approve of software validation protocols and reports.
5.1.11.10 To review and approve User Requirement Specification.
5.1.12 Document Control and Records:
5.1.12.1 QA is responsible for controlling, issuing, distribution and retrieval of various documents and records such as SOPs, BMRs, BPRs, log books, formats, specifications, STPs, protocols and layouts.
5.1.12.2 Maintain accountability/distribution record for such documents controlled and issued.
5.1.12.3 Overall control on documents up to their retention period, ensure destruction of records after completion of retention period as applicable.
5.1.13 Vendor Management:
5.1.13.1 Prepare and distribute Approved vendor list, updating the vendor lists in timely manner.
5.1.13.2 Maintain all vendor related documents which are received from CQA.
5.1.14 Self-Inspection:
5.1.14.1 Plan and conduct self-inspection.
5.1.14.2 Prepare a report of the observations and recommendations, communicate to auditee and HOD of the audited department, and obtain CAPA for the observations and follow up for implementation of CAPA.
5.1.14.3 If required, follow up audit shall be performed to verify the effectiveness of corrective and preventive action of CAPA.
5.1.14.4 Verify audits are performed according to the annual schedule and reports are filled.
5.1.14.5 Notify critical observations to senior management immediately.
5.1.15 Annual product Review:
5.1.15.1 Preparation, review and approval of annual product quality review of all products.
5.1.15.2 Identify if there are any abnormal trends in the results of API, semi-finished product, finished product and also in process parameters.
5.1.16 Management Review Meeting:
5.1.16.1 To conduct review meeting as per SOP on management review meeting.
5.1.16.2 Ensure actions related to quality functions, as identified in management review meeting, are taken in timely manner.
5.1.17 Technical Agreements:
5.1.17.1 Review and approval of technical agreements from the customers and external laboratories.
5.1.17.2 To ensure appropriate agreements are in place with the customers and external laboratories and they are updated timely.
5.1.18 Risk assessment:
5.1.18.1 To assess the risk associated with environmental conditions, materials, critical process parameters, manufacturing/packing process, in process parameters etc.i.e. Thought the life cycle of the product through appropriate risk assessment tools.
5.1.18.2 Risk assessment of practices and systems to ensure appropriate control and mitigation plan in case of risk identification.
5.1.19 Qualifying Contract laboratories:
5.1.19.1 To audit, evaluate and qualify external testing laboratories as per laid down procedures.
5.1.20 Hosting External Audits:
5.1.20.1 QA shall host external customer/sponsor audits, regulatory inspections and any relevant audits on GMP systems.
5.1.20.2 Responsible for timely response to observations reported in audit reports by customer/sponsor, in coordination with concerned staff.
5.1.20.3 Monitor that CAPAs for external audit observations are completed as per committed timelines, Any deviations shall be communicated to customer/sponsor.
5.1.21 Environmental trends, Water trends, Stability trends:
5.1.21.1 Review and approval of trends/summaries of environment and water.
5.1.21.2 Any Out of trend results including stability studies shall be investigated and documented.
5.1.22 Supporting Regulatory Department:
5.1.22.1 To review and submit the documents of exhibit batches to regulatory department for the registration purpose.
5.1.22.2 To address the queries related to quality functions from regulatory agencies.
5.1.23 Release of Finished products:
5.1.23.1 Review of online BMRs, BPRs and other supporting records with respect to manufacturing, packing and cleaning of areas and equipment’s, analytical data of in process and finished products for batch disposition.
5.1.23.2 The pharmaceutical products are not released for sale or supplied before authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the label claim and any other provisions relevant to production, control and release of pharmaceutical products.
5.1.24 Art Work:
5.1.24.1 To review and approve/reject the artworks including proofs of printed packing materials.
5.1.25 Factory Acceptance Test/Qualification:
5.1.25.1 QA shall arrange and participate in Factory Acceptance Test and Qualification of the Equipment’s.
5.1.26 Pest Control program:
5.1.26.1 QA shall verify the pest control program in the premises.
5.1.27 Trends and Summaries of Quality System Elements:
5.1.27.1 Preparation of summaries for quality system elements such as deviation, incident, change control and OOS.
5.1.27.2 Evaluate trends and provide recommendations to improve quality, safety and efficacy of the product.
5.1.28 Disposition of materials/products:
5.1.28.1 The Quality Assurance Unit has the authority to approve or reject all components, drug product containers and closures, in process materials, packaging materials, labeling and drug products.
5.1.29 Storage Conditions:
5.1.29.1 QA is responsible to ensure storage of raw materials, packing materials, in process, semi-finished and finished products as per recommended storage conditions.
5.1.30 Approval of Contract manufactures:
5.1.30.1 QA is responsible for approving intermediate and finished product contract manufactures.
5.1.31 Quality System:
5.1.31.1 Quality assurance unit is responsible for quality system planning, implementation of cGMP in plant and maintain compliance of manufacturing activity with regulatory requirements.
5.1.31.2 The system of quality assurance appropriate to the manufacture of pharmaceutical products shall ensure;
5.1.31.3 Adequate arrangements are made for manufacture, supply, and use of the correct starting and packaging materials.
5.1.31.4 Adequate controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.
5.1.31.5 The finished products are correctly processed and checked in accordance with established procedures.
5.1.32 Tech Transfer Activities:
5.1.32.1 Quality Assurance unit is responsible for review of tech transfer activities.
5.1.33 Transit Study:
5.1.33.1 Quality Assurance unit is responsible for conducting transit study validation and review the transit data.
5.2 Responsibilities of Quality Control Laboratory:
5.2.1 Testing for physical or chemical characteristic of the drug substances, excipients, in- process, intermediate and drug product, packaging components.
5.2.2 Adequate area having the required storage conditions shall be provided for keeping reference samples. The quality control department shall evaluate, maintain and store reference samples.
5.2.3 The Quality Control Unit shall maintain the control samples / reserve samples of the raw materials / finished products.
5.2.4 The Quality Control maintains adequate laboratory facilities necessary for all required testing.
5.2.5 There shall be authorized and dated specifications for all materials, products, including test of identity, content, purity and quality.
5.2.6 Quality control personnel shall have access to production and warehouse areas for sampling.
5.2.7 The quality control department shall conduct stability studies of the products to ensure and assign their shelf life at the prescribed conditions of storage. All records of such studies shall be maintained.
5.2.8 All instruments shall be calibrated and testing procedures validated before these are adopted for routine testing. Periodical calibration of instrument and validation of procedures shall be carried out.
5.2.9 Each specification of raw materials, intermediates, final products, and packing materials shall be prepared, reviewed and maintained by the Quality Control Department. Periodic revisions of the specifications shall be carried out whenever changes are necessary.
5.2.10 Pharmacopoeias, reference standards, working standards, reference spectra, other reference materials and technical books, as required, shall be available in the Quality Control Laboratory.
5.2.11 Standard operating procedures shall be available for sampling and testing of raw materials, in process and finished products and packing materials and, wherever necessary, for monitoring environment conditions.
6.0 ABBREVIATION:
6.1 SOP :Standard Operating Procedure.
6.2 QA :Quality Assurance.
6.3 QC :Quality Control
6.4 MAH :Marketing Authorization Holder
6.5 OOS :Out of Specification
6.6 STP :Standard Testing Procedure
6.7 API :Active Pharmaceuticals Ingredient
6.8 BMR :Batch Manufacturing Record
6.9 BPR :Batch Packing Record
6.10 CAPA :Corrective and Preventive Action
6.11 HVAC :Heating Ventilation and Air condition
6.12 cGMP :Current Good Manufacturing Practice
6.13 FP :Finished Product
6.14 RH :Relative Humidity
7.0 REFERENCES:
8.0 LIST OF ANNEXURES:
Nil