In the present scenario the context of Quality has emerged as an important factor. If we precisely define Quality it means meeting the specifications that are summarized keeping in mind the demand of today’s fast changing world.

If we talk of Pharmaceutical Industry, quality becomes an unavoidable thing. Quality management in pharmaceutical industries, is an important subject because the drugs / or pharmaceutical products are directly delivered to the customers body system, thus identity, purity safety and ultimately appropriate quality of product are strongly essential.

There are numerous guidelines worldwide that has made some sort of rules and specifications which must be followed by every pharmaceutical industry. To maintain quality in pharmaceutical products, Quality Management System is followed.

Developing an ISO 9001 Quality Management System (QMS) requires a lot of effort to create a system, change employee behavior (management and workers), and obtain the desired results. Many companies have successfully built an ISO QMS, passed their initial registration audit, and later failed to maintain all of the documents, records, and quality process activities.

Creating an ISO QMS is one thing but maintaining it can be just as difficult for your organization. For companies, implementing a QMS{Quality Management System} based on ISO 9001 or one of the related standards is becoming a necessity

It can help win new customers as well as retain existing ones. While the goal is to achieve registration to one of these standards, it is not the only goal. The internal benefits of implementing an effective QMS are significant.

The customer is the ultimate judge of quality

Quality management in pharmaceutical industries, is an important subject because the drugs / or pharmaceutical products are directly delivered to the customers body system, thus identity, purity safety and ultimately appropriate quality of product are strongly essential. Guidelines are established with a view to bring uniformity in the products worldwide. It helps in export and import of drug products worldwide. Maintaining quality in the products is a complex process and needs to take into account various guidelines like GMP, GLP and many more.

Implementing a QMS may seem daunting, but fortunately the standards are flexible.

They mandate requirements for an organization to follow but allow you to fulfil the requirements in a way that makes sense for your business.

This allows a wide range of companies, both large and small, manufacturing and service to create a QMS that meets the specific needs of their business as well as the requirements of the appropriate standard.

Every organization has management procedures and instructions for creating and delivering their products and services to customers. Most have evolved over the years, and are generally adequate – if they weren’t, organizations would quickly go out of business.

However poor management systems can lead to wasteful processes, poor products and services, and dissatisfied customers.

Keep in mind that a core problem with ISO 9000 implementation is communication. An effective quality implementation is really about effectively communicating with customers, suppliers, employees, and management to identify, meet, or exceed requirements. Quality, sales, marketing, design, manufacturing, accounting, and management must all communicate using the same language

An efficient organization can typically be characterized by:

  • Explicit awareness of, and concern for, the needs of customers and other stakeholders (suppliers, employees, society, etc.),
  • Senior and middle managers who focus on business needs.
  • A commitment to improve products and services,
  • Employee development and training programs that meet the needs of the organization,
  • Processes designed to identify and reduce wasted resources,
  • Complete, current, clear and relevant documentation

Plan-Do-Check-Act cycle is a model for carrying out change. It is an essential part of the lean manufacturing philosophy and a key prerequisite for continuous improvement of people and processes. First, proposed by Walter Shewhart and later developed by William Deming, PDCA cycle became a widespread framework for constant improvements in manufacturing, management, and other areas.

PDCA is a simple four-stage method that enables teams to avoid recurring mistakes and improve processes.

Organizations are increasingly introducing formal Quality Management Systems (QMS) to gain these and other benefits.

The general components of a QMS.

  1. Customer Focus: Customer’s needs and expectations need to be identified and achieved.
  2. Leadership: Top Management must show their commitment to the QMS by leading, communicating and uniting everyone in the organization to achieve the company’s desired goals and by providing the resources necessary to accomplish them.
  3. Involvement of people: Irrespective of their position in the company everyone is involved in the QMS.
  4. Process Approach: This will provide for a systematic definition of activities in order to meet the stated goals and identify the resources required to meet those goals.
  5. Systems Approach to Management: Requires identifying all of the processes in the company and their interdependence and then managing these processes as a complete system.
  6. Continual Improvement: It is a never-ending process involving establishing goals and measuring progress towards achieving those goals.
  7. Factual Approach to Decision Making: Using it to make sound decisions on what path to take.

Managing Change

The journey from a pre‐QMS organization to one that operates with the quality and controls necessary for certification is not a casual task and is unlikely to succeed without the commitment and dedicated support of top management.

The greatest resource a company has is its people, inevitably there will be resistance to changes when implementing and maintaining your Quality Management System (QMS).

Resistance has many faces including denial, lack of motivation and questioning of the motivation behind the decision to implement a QMS. Strategies for managing change should be addressed during implementation planning.

For Management change is

  • Planned
  • Gradual
  • A Solution
  • Logical
  • Opportunistic

For the people affected change is…

  • Out of their control
  • Sudden
  • Problematic
  • Arbitrary
  • Disruptive


The aim of a QMS is to assure that an organization consistently meets customer needs by controlling the core processes that affect them such as sales orders, design, production, inspection, delivery, etc.

The requirements also go beyond these “core” processes to address support processes like purchasing, training, calibration, maintenance, and performance metrics.

Building a Quality Management System:


1. Define and Map Your Processes

2. Define Your Quality Policy

3. Define Your Quality Objectives

4. Define Your Defects for Each Process

5. Develop Your Documents and Records

6. Define Your Quality Process

7. Determine Your Training Needs

8. Use Your Quality Management System

9. Measure and Monitor Your Performance

10. TAKE ACTION That Improves Your Performance

The term quality cannot be confined to one definition. People define it in their own ways but one thing is common in all and that is satisfaction. Manufacturer is satisfied if the product meets it specification and consumer is happy when the particular product fulfils his need. But in anyways Quality is unavoidable thing today and one cannot ignore it. When it comes in context of Pharma then Quality is a legal issue and must be maintained in pharmaceutical products.

Source: Secondary Research and company news letter

Written by:


A Pharma professional with width and depth of experience spanning 39 years across key functions in the pharma space (start-up/Large Indian Co / Growing / MNC) having Excellent track record of providing leadership with Core competence in Sales, Business Development/Marketing, Distribution/Logistic at All India Level. Currently Heading Compliance Department at Jagdale Industries Pvt Ltd. Also Mentoring in Pharmaceutical Consulting & Market research.