FORMAT FOR QUALITY MANUAL FOR PHARMA COMPANY | DOWNLOAD FULL COPY

QUALITY MANUAL
TITLE                         : Contents
DOCUMENT No.      : DSM/QA/01	REVISION No.           : 00
PAGE No.                    : 01 of 01	EFFECTIVE DATE   :

Sr. No.	Name of Document	Document No.
1.	Cover page	--
2.	Contents	DSM/QA/01
3.	List of Controlled Copy Holders	DSM/QA/02
4.	Introduction	DSM/QA/03
5.	Quality Policy	DSM/QA/04
6.	Quality Objectives	DSM/QA/05
7.	Departmental Organogram	DSM/QA/06
8.	Responsibilities and Authorities	DSM/QA/07
9.	Activity Flow Chart	DSM/QA/08
10.	Quality Procedure	DSM/QA/09
11.	Quality System	DSM/QA/10
12.	Notification to Management	DSM/QA/11
13.	Abbreviations	DSM/QA/12
14.	History Sheet	DSM/QA/13

 

List Of Controlled Copy Holders

 

Sr. No.	Controlled copy holder	Copy No.	Department
1.	Quality Head	01	Quality
2.	Quality Assurance Department	02	QA
3.	Auditor Copy	03	QA

Introduction

 

 

            Quality Department ensures that quality is built in the product through implementation of Quality Assurance Systems & Procedures. Quality Department is responsible for ensuring Safety, Identity, Strength, Purity and Quality of the each product manufactured.

 

Quality management at ------------------------ is inter-related concepts of Quality Assurance, Quality Control and cGMP.

 

There are two divisions of Quality Department.

 

1).        Quality Assurance Department

 

2).        Quality Control Department

 

                Quality Assurance Department is responsible for ensuring In-process control, Raw Material & Packing Material control, Batch Record Audit, Bulk Preliminary Approval for packing of bulk products & Releases Finished Product for sale / Export, Process Validation, Equipment Qualification, Cleaning Validation, Change control programme, Deviation procedure, Incident & Investigation Procedure, Document Control, Self Inspection and Audit, Training, Handling of Market Complaint and Factory Hygiene are followed as per company’s Standard Operating Procedures and guidelines.

 

The quality Control Department is responsible for ensuring the compliance of the Raw Material & Packing Material to approved specifications, compliance of In-process & validation samples to approved specifications, and compliance of Finished Products to approved specifications. Moreover the Quality Control Department ensures the quality systems like Vendor Rating, Stability Study, Analytical Method Validation, and Microbial Purity Control are followed as per the company’s Standard Operating Procedures and guidelines.

 

This reveals that the Quality Assurance Department ensures the process is always under control through in-process checks and validation activities. Means Quality Assurance ensures process control while Quality Control Department ensures product control through Raw Material, Packing Material, In-process samples & Finished Product analysis, and QC releases.

 

            Both the Quality Assurance and Quality Control Departments report to the Quality Head of the Plant.

Quality Policy

 

• The philosophy of the company is to win and retain customers through excellent services and provide a consistent level of quality comfort.

 

• The company is committed to consistently manufacturing and delivering Pharmaceutical Products of dependable quality that comply with national and International Quality Standards.

 

• The assurance of high quality is by strictly adhering to current Good Manufacturing Practices. This compliance ensures consistent Quality, Safety, and Efficacy of products.

 

• Consistently high-quality standards will be reached through a team effort and with the contribution of trained personnel through ongoing training that results in transparent and effective Quality Management.

 

• The factors that contribute to a sound quality culture at ........ are effective communication, participation of all personnel, adoption of contemporary technology, design of the state-of-the-art facility, installation of sophisticated equipment, and building a sound scientific understanding.

 

• Every individual has a definite role and responsibility. This role definition ensures that each team member contributes significantly to all aspects of our integrated manufacturing operation.

 

• We believe in and emphasize continuous improvement in all areas of our functioning to achieve excellence. We set achievable and well-defined goals and measure performance periodically against defined standards.

 

• The company is committed to providing a safe and secure working environment.

 

• The company is committed to better living, it seeks to manufacture and distribute products that result in a better quality of life for people the world over.

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