SOP for Responsibilities of Quality Assurance Department
1.1 To define the responsibilities of Quality Assurance Department for implementing an effective Quality Management System.
2.1 This procedure describes the functions and responsibilities of quality assurance department.
3.1 QA personnel shall carry out the responsibilities mentioned in this SOP.
4.1 Head - QA is responsible for the implementation of this SOP.
5.1 Establish a system to release or reject raw materials, intermediates, packing materials, labeling materials, all components of drug product containers, closure, in-process materials, drug substances and drug products.
5.2 Approve or reject the drug substance/drug products manufactured, processed, packed or held under contract by another company.
5.3 Review completed batch production and laboratory control records of critical process steps before release of the API for distribution.
5.4 Ensure that critical deviations are investigated and resolved.
5.5 Approve all specifications, test procedures, master production instructions and all procedure impacting on the on the identity, strength, quality and purity of intermediate, drug substance and drug product.
5.6 Investigate and address all quality-related complaints.
5.7 Approve intermediate and API contract manufacturers as per SOP.
5.8 Review and approve all validation protocols and reports.
5.9 Review and approve all the stability study protocols and reports.
5.10 Manage change controls, product recalls and OOS investigations.
5.11 Ensure that maintenance and calibration of equipment/ instruments are done as per schedule.
5.12 Ensure that the storage and transport conditions specified for intermediate products or API are adhered.
5.13 Ensure that stability data is available to support expiry and/or retest date for intermediate, drug substance and drug product where appropriate.
5.14 Perform internal audits
5.15 Perform annual product quality review.
5.16 Review and approve any quality related documents for customer support.
5.17 Review and approve product development reports.
5.18. Ensure that the environmental monitoring program of the production areas is properly implemented.
5.19 Review and approve technology transfer documents.
5.20 Ensure that the training programs are conducted properly as per schedule.
5.21 Ensure that the preventive maintenance and calibration program are done as per schedule and make sure that they are correctly performed.
5.22 Review and approve any quality related document in their respective unit.
5.23 QA department shall be responsible to investigate market complaints and to maintain market complaints investigation records.
5.24 QA department shall be responsible for auditing methods, results, systems and processes and for performing the trend analysis and preparation of annual review of drug product quality.
6.1 QA - Quality Assurance
6.2 API - Active Pharmaceutical Ingredient
6.3 QMS - Quality Management System
6.4 SOP - Standard Operating Procedure
6.5 OOS - Out of Specification
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Last Updated : 10-06-2018 11:26:00 am
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