Quality System

Major Quality To Maintain The Facility In The State Of Validation

Quality System Concept

The quality system typically applies to and interacts with all activities pertinent to the quality of a product.
It involves all phases from initial identification to final satisfaction of requirements and customer expectations starting from marketing and market research, design/ specifications.
Engineering and product development, production, inspection, testing, examination, packing and storage, sales and distribution, installation and operations of the machine, technical assistance and maintenance.
Periodic self inspection/ internal audit are conducted as per defined planner by team, comprising of cross- functional departments or external auditor to review and ensure effective implementation of quality system and cGMP compliance.
Self inspection and internal audits finding are recorded and corrective measure are taken for compliance. Records of self inspection and audit are maintained

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

To manufacture finished products by environment controlled clean area using HVAC system.
To ensure the cleanliness of the manufacturing area, equipment's before start of the manufacturing activity.
To verify the quality of the dispensed raw materials against the batch records. Bills of material
Control of labeling and packing materials and reconciliation of materials.
To be part of validation team for qualification and validation of process and process equipment's.
To ensure that the manufacturing of the product is done in accordance to the instructions provided and to fill the relevant activities as per cGMP & Good documentation practices (GDP)
On job training
Coordination with quality assurance department.

Responsibility Of Warehouse

Proper placement of raw material and packing materials so as to maintain the identity and avoid cross contamination.
Storage of raw materials and packing materials on FEFO (first Expiry Fist Out)basis and packing materials on a FIFO (First in First Out) basis.
To ensure that only the APPROVED materials are issued for production.
To dispatch only the batches approved & released by quality Assurance.
To maintain the appropriate storage conditions for the finished goods.

Quality System

Major Quality To Maintain The Facility In The State Of Validation

Quality System Concept

QUALITY SYSTEM

Release Procedure For Finished Product

QUALITY SYSTEM CONCEPT

Standard Specifications And Standard Testing Procedures

Standard Operating Procedure

Batch Manufacturing Record

Deviation

Change Control

Responsibility Of Production

Responsibility Of Warehouse

Responsibility Of Engineering

Responsibility Of Quality Control

Responsibility Of Quality Assurance Department

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