NAM GROUP OF INDUSTRIES PRIVATE LTD.

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Quality System

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Major Quality To Maintain The Facility In The State Of Validation

Quality System Concept

QUALITY SYSTEM

Release Procedure For Finished Product

Manufacturing activity is carried out under the supervision of approved manufacturing chemist after the completion of labeling and packing operation; finished goods are transferred to finished goods under test/ Quarantine area and batch record duly reviewed by approved manufacturing chemist are sent to QA for review. On completion of testing under supervision of approved analytical chemist, the certificate of Analysis is sent to QA for review. On satisfactory compliance with both finished product specifications and batch integrity requirement, the QA department will issue a batch release note duly approved by head QA or his designee. In case a finished product fails a particular test or does not comply with the specifications then a complete investigation is initiated by QC and closed by head QA after complete root cause analysis and necessary corrective and preventive action.

QUALITY SYSTEM CONCEPT

Standard Specifications And
Standard Testing Procedures

Specification & testing procedures are prepared in compliance with relevant pharmacopeia and are reviewed to meet current pharmacopeia recruitments.

Standard Operating Procedure

Standard operating procedures (SOPs) are established to specify procedures, method and systems for all activities related to the development, manufacturing, storage and distribution of marketed products, SOPs contain relevant information about the documents and procedures to be followed such as cleaning, operations, calibration, validation,maintenance,training and documentation etc., to be performed.

Batch Manufacturing Record

Batch production records are documents in accordance with prescribed specifications and provide means for ensuring that the product is manufactured under controlled and orderly conditions

Deviation

Any deviation to the established procedure or process are reported to the quality assurance department and are thoroughly investigated for any impact on quality, deviation investigation and any supporting activities/actions are documented as per deviation management SOP.

Change Control

Any proposed change to a process, facility, material or equipment is reviewed by a change control committee, comprising Quality, production and senior management, the decision and supporting activities/ actions are documented as per change control SOP.

Responsibility Of Production

Responsibility Of Warehouse

Responsibility Of Engineering

Responsibility Of Quality Control

Responsibility Of Quality Assurance Department

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