QUALITY ASSURANCE MANUAL

Table of contents

1.       Scope:

This Quality Assurance document applies to the department of Quality Assurance of company.

This QA manual describes the control procedures and practices of company’s quality system and lists current standard documents.

 2.       Objectives:

The objective of the QA system, as delineated in this manual, is to provide structured activities within the company which promote efficient and cost effective manufacturing and testing operations resulting in quality products/ services that satisfy regulatory and client requirements.

The objective of this QA manual is to provide an internal working document for the company QA Department.

To promote uniformity of working methods throughout the facility

The appropriate procedures shall be implemented at all times without unauthorized deviation.

 3.       Quality Operations:

        Quality Assurance Department Ensures:

3.1.  Production and Control Operations are clearly specified and Good Manufacturing Practice adopted.

3.2.  Managerial Responsibilities are clearly specified.

3.3.  Arrangements are made for the manufacture, supply and use of the correct Starting and Packaging Materials.

3.4.  All necessary Controls on Intermediate Products, and any other In-Process Control.

3.5.  All Equipment, Machines, Instruments Validations (OQ, PQ) and Calibrations are carried out.

3.6.  Monitoring and Control of Product Recalls & Complaints.

3.7.  That the Finished Product is correctly Processed and Checked, According to the Defined Procedures.

3.8.  Satisfactory arrangements exist to ensure, as far as possible, that the Products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life.

3.9.  Personnel Training.

3.10.       Monitoring and control of Environment.

3.11.       Documentation Reviews & Control are done.

3.12.       Vendor Qualification/ Evaluation.

 4.       Reporting:

Quality Assurance department Reports:

4.1.          Deviations in Batch Processing.

4.2.       Deviations in Quality Control Test Results.

4.3.       Sanitation and Hygiene Issues in the Facility.

4.4.       Any deviation from Standard Procedures regardless of department concerned.

 5.0. Personnel:

5.1.  Quality Assurance Department ensures that the personnel trainings are carried out promptly.

5.2. QA department ensures that Job Descriptions of Personnel’s are written, controlled, reviewed and distributed to the concerned individual.

5.3. QA department ensures that personnel’s issues are resolved.

5.4. QA department is responsible for maintaining Good Working Environment within the premises.

6.0.  Documentation:

                                QA department Ensures:

6.1.  Document Control, Issuance, Review & Obsoleteness.

6.2.  Document Record Keeping.

6.3.  Document Numbering.

6.4.  Ensures Traceability & Audit Trial for Investigation.

6.5.  Ensures availability of Data for Validation, Review and Statistical Analysis.

6.6.  Ensures that all Documents are Approved, Signed and Dated by appropriate Authorized Personnel.