1.0 INTRODUCTION

1.1 Overview of The Organization:

In order for Company Name, Location is to establish its position as one of the nation’s premier drugs manufacturers, it is essential that we consistently meet or exceed our customers’ requirements and expectations for the quality, performance, timeliness, and cost of the products and services we provide.

This manual defines the Company Name, Location policies that reflect the requirements of GMP, Quality Systems- Model for Quality Assurance in Design, Development, Production, Installation, and Servicing. Implementation of these policies ensures that we consistently meet the quality and performance requirements of customers in a timely and cost- effective manner. I personally affirm my commitment to enhancing the Company Name, Location Quality System through the implementation of GMP.

2.0 Objectives:

This manual is used to familiarize our customers, interested parties, or individuals with the controls that have been implemented and to assure them that the integrity of our QMS is maintained and is focused on meeting its intended outcomes.

This Quality manual is a documented overview of the efficacy of the established quality system, and serves as a conduit for the identification and ultimate implementation of continuous improvement initiatives.

The Quality manual authorizes and governs the creation of subsidiary quality-related documentation, as promulgated by Standard Operating Procedures (SOPs), guidelines and policies as they relate to GXP operational areas throughout the organization.

3.0 Scope:

This Quality manual describes the quality management system of the Company Name, Location its scope is for:

Internal use to communicate to staff the company Quality Policy and quality objectives, to make the staff familiar with the processes used to achieve compliance with quality requirements. This should facilitate the implementation of the quality management system as well as ensure its maintenance and required updates during altering circumstances. This should also allow effective communication and control of quality related activities and a documented base for quality system audits.

External use to inform the customers/ regulatory bodies about its Quality Policy as well as its implemented quality management system and measures of compliance with quality.

4.0 Quality Management Principles:

To lead and operate an organization successfully, it is necessary to direct and control it in a systematic and transparent manner. Success can result from implementing and maintaining a management system that is designed to continually improve performance while addressing the needs of all interested customers.

Nine quality management principles have been identified that can be used by top management in order to lead the organization towards improved performance.

• Customer focus.
• Leadership.
• Involvement of people.
• Process approach.
• System approach to management.
• Continual improvement.
• Factual approach to decision making.
• Effective decisions are based on the analysis of data and information.
• Mutually beneficial supplier relationships.

5.0 Quality Statement:

The Quality statement of company to comply with all requirements of the quality system to ensure that their customer's requirements including quality, cost and delivery are met or exceeded and to continually improve the effectiveness of the quality system at Company Name, Location our objective is to go beyond compliance and strive for:

Maintaining the highest quality standards and continuous improvement throughout our quality system.

Anticipation and proactive management of regulatory evolution.  

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1.0 Purpose

The purpose of Site Master File is to maintain information about the Organization, Layouts, Activities related to Manufacturing, Packaging and Labeling, Quality Control, Quality Assurance of pharmaceutical manufacturing operation, Quality Management Policies, GMP related activities, that shall be useful in general supervision and conducting regulatory / customer’s inspections.

2.0 Scope

This Site Master File is applicable to XYZ Limited,

3.0 General Informationon The Manufacturer

3.1Contact Information of the Manufacturer

     Name and Address of the Site

     XYZ Limited

     Address of the Site.

      Phone                          : 

      Phone (24 hours)         : 

      Fax                              : 

      Registered Office Addres                                                                     

XYZ Limited                 

Address of Corporate office

Phone                          : 

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GMP Audit Checklist provide the guidance and checkpoint for conducting the GMP audit of the manufacturing facility. The Main areas are covered:-

1.0 Building and Facilities 

2.0 Materials Management

3.0 Quality Control Systems

4.0 Manufacturing

5.0 Packaging and Identification Labelling

6.0 Quality Management Systems

7.0 . Personnel and Training

8.0 Purchasing and Customer Service

9.0 . Retained Samples

10. Non-conforming products management

11.0 Complaints vigilance

12.0 Distribution

13.0 Sub-contractors

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1.0 OBJECTIVE

This Validation Master Plan is written to describe [Site Name, Location] intention and approach towards validation in achieving the objective of providing quality product. This Validation Master Plan shall serve as a summary of the overall strategy for the validations to be executed in the facility to demonstrate that the critical equipment, systems and processes perform as designed and intended.

2.0 SCOPE

This VMP addresses the all-validation activities related to equipment, utilities, processes, systems and procedures that may impact the product quality at the manufacturing blocks of [Site Name, Location], Goa. Specific systems, equipment, utilities and procedures to be qualified and processes (listed below) to be validated shall be exercised on basis of approved qualification / validation protocol. 

• Utilities (HVAC, Compressed Air, Water)

• Equipment / Instrument

• Product Manufacturing Process

• Cleaning Process

• Sterilization Process

• Computer and Computerized Systems (PLC, SCADA, LIMS, SAP etc.)

5.0 VALIDATION APPROACH

This Validation Master Plan shall follow lifecycle validation approach to validate product manufacturing and other auxiliary processes. This approach shall ensure quality from the very first step. This Validation Master Plan shall provide guidance and directions for development of requirements, specifications and actions to qualify and finally accept and release the equipment, system, facilities and validated process for use. The VMP shall also provide guidance on life cycle management of equipment, system and process.

The life cycle approach involves a series of activities taking place over the life cycle of the equipment, system, product and process. The VMP describes the activities in three basic stages:

Stage 1 - Design: The equipment, system and process are defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2 – Qualification / Validation: During this stage, the design is evaluated to determine if it is capable of reproducible performance.

Stage 3 – Continued Verification: Ongoing assurance is gained during this phase that the equipment, system and process remain in a state of control.

A brief flow of product and equipment / facility / utility lifecycle is as below:

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