The document outlines the importance of a Quality Management System (QMS) in the pharmaceutical industry, emphasizing the necessity of meeting specifications for identity, purity, and safety of medicines. It highlights guidelines such as GMP and ICH that organizations must follow to maintain quality and the role of quality assurance departments in ensuring compliance. Additionally, it discusses quality management principles applicable across various industries, including textiles, focusing on continuous improvement and customer satisfaction.

1. QMS Defined
A set of coordinated activities to direct and control an organization in order to continually improve the
effectiveness and efficiency of its performance.
Quality Management System in Drug Industry:
Quality of medicines means meeting the required specifications. 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. ICH 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. There is a Quality assurance
department in all the Pharma industries whose job is to look if all the required guidelines are being followed in
the industries or not. Quality auditing is the process through which they check internally or externally and ensure
everything is running right. The present paper focuses on the Quality management system in the Drug industry
and their elements.
Introduction
In the present scenario the context of Quality has emerged as an important factor. People are wise enough to
choose things that assure to fulfill their demands. 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. Internationally harmonized guidance ICH Q10 governs the concept of current
pharmaceutical quality management systemfor Registration of Pharmaceuticals for Human Use and USFDA and
in final phases [1].
Quality Management System (QMS)
Quality management is defined as the aspect of management function that determines and implements the
“quality policy”, i.e. the overall intention and direction of an organization regarding quality, as formally
expressed and authorized by top management. The basic elements of quality management are: a) An
appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures,
processes and resources b) Systematic actions necessary to ensure that a product (or service) will satisfy given
requirements for quality. The totality of these actions is termed “quality assurance
The Top Ten Responsibilities of the Pharmaceutical Quality Unit
a) To establish the quality system b) To audit compliance to the quality system c) To establish procedures and
specifications d)To establishmanufacturing controls e) To perform laboratory tests or examinations f)To review
and approve or reject all things cGMP g) To ensure investigation of non-conformance h) To keep management
informed i) To describe responsibilities in writing j) To remain independent Elements of Quality Management
System

2. A quality management system typically consists of four facets
Quality planning: Process of translating quality policy into processes, procedures, and instructions to
achieve measurable objectives and requirements b) Quality assurance: Planned and methodical activities
executed as part of a quality system to provide confidence that process, product, or service requirements
for quality are being satisfied c) Quality control: Act of monitoring, appraising, and correcting a process,
product, or service to ensure requirements for quality are being satisfied d) Quality improvement: Process
of analyzing performance and taking methodical, systemic actions to improve it.
Quality Management System in Testing Laboratories
Professionals of testing laboratories have shown increasing interest in understanding the QMS and
attaining accreditation status for their services since the introduction of international standards for the
quality management system (QMS). Thus Quality assurance therefore is defined as the process or the end
of the process which confirms for the integrity of a product to meet the standard for the intended use.
Quality assurance is an obligation automatically imposed on the manufacturer of any product to ensure
that it meets the needs of the end-user in the measures intended for use. For the end-user, the benchmark
of quality is perfection they cannot allow less than 100%.
Elements of the Quality Management System
The laboratory is a complex system, involving many steps of activity and many people. The complexity of
the system requires that many processes and procedures be performed properly. Therefore, the QMS
model, which looks at the entire system, is very important for achieving good laboratory performance. The
QMS is defined as a ‘management system to direct and control an organization with regard to quality. The
QMS covers the laboratory activities, including drug sampling, analysis and reporting. The QMS consists of
documentation of the laboratory policy and objectives, system procedures and instructions for assuring
the quality of its results to meet safety and regulatory requirements and to satisfy the needs of the
customers.
Pharmaceutical Quality Management System
It is applicable to drug products, including biotechnology and biological products, throughout the product
lifecycle the systems supporting the development and manufacture of pharmaceutical drug substances. It
includes: Pharmaceutical Development a) Manufacturing and development of APIs. b) Manufacture of
medical kits and devices for investigation. c) Development of medical delivery systems. d) Pilot plant scale-
up activities e) Manufacturing process of formulation f) Development of medical devises for accurate
dosing
Analytical Method Development
During Manufacturing Process a) Acquisition and control of materials b) Provision of facilities, utilities, and
equipment c) Production (including packaging and labelling) d) Quality control and assurance e) Release f)
Storage
During Product Technology Transfer /

3. During product discontinuation a) Retention of sample and related documentation b) Continued product
assessment and reporting
Are QMS Suitable for labour intensive industry like Textile and Apparel ?
The answer is abundantly yes. Operations heads in apparel industry often express their inability to standardize
the processes due to product variability, unpredictable market (fashion) trends etc. One of the leading
aerospace industry implementing TQM is an excellent example to refute these claims1. The company sources
components from vendors located across the globe. It is subjected to far more market risk compared to apparel
industry, including design changes, interest rates, exchange rates, and commodity prices. The company meets
its delivery schedule where the cost of delay is catastrophic. Interestingly it is not the process or product
limitation but psychological factors that cause the reluctance among garment professionals in implementing
TQM.
Each Quality management systems (TQM, ISO etc) and its elements (Statistical process control, (SPC), Kaizen,
Advance product quality planning and control (APQP), have a distinctive applicability. It is necessary that the
approach selected suits current and future needs of the organization. SPC works towards bringing process under
the influence of common causes alone by identifying & eliminating assignable causes. APQP focuses mainly on
new product development / project execution. ISO 9000 currently includes three quality standards (ISO
9000:2005, ISO 9001:2000, and ISO 9004:2000). ISO 9001:2000 presents ISO's new quality management
system requirements, while ISO 9000:2005 and ISO 9004:2000
Present ISO's new quality management system guidelines. All of these are process standards & not product
standards and are developed by quality experts from around the world for use by companies that either want
to implement their own in-house quality systems or to ensure that suppliers have appropriate quality systems
in place.
Quality management can be considered to have three main components:
 Quality control
 Quality assurance and
 Quality improvement
Quality management for production:
The merchandiser acts as the one point person for all communications with the customer. Whether there is a
delivery problem or quality problem or approvals or anything, the merchandiser has to communicate with the
customer and make him understand the situation. To be able to do so it is important that the merchandiser
understand the quality and production norms.
The merchandiser is expected to understand:
 Garment quality (visual, measurement, construction)
 Testing quality (fabric, trims and garment)
 Packaging quality.
Quality Management System (QMS):
Quality Management System (QMS) is a series of interrelated techniques and management systems that helps
to prevent defects from occurring time or if they occur at all, countermeasures are adopted as soon as

4. possible so that defects do not recur. Quality Management System (QMS) takes recourse to preventive as well
as remedial measures.
Step by Step Quality Management System (QMS) in the Garment Industry:
Quality management systemis a number of measures and techniques that are used to produced only quality
goods in the first place and defects do not create at all. If the defects are occurring at all, there must be
applying corrective action to eliminate these defects in the initial stage and would not reappear.
Quality Management System (QMS) generally employs the following measures, techniques to ensure that only
high quality good are produced:
1. Inspect the all incoming, in-process & final goods to ensure quality of goods.
2. Make sure that all patterns & pattern grading are okay.
3. Check the markers, marker making methods, marker efficiency if it is okay and within consumption.
4. Inspect spreading, cutting & numbering process in detail.
5. Ensure the relaxation time that was given to knit fabric.
6. Install in-line inspector in the sewing lines.
7. To monitor quality in production line they install Traffic Light Chart system or other system.
8. Inspect 100% goods delivered from sewing lines.
9. Inspect the table quality inspection for in line passed garments with Statistical Technique.
10. Control the reject garment so that they do not mix up with quality passed garment.
11. Have to control repairable goods, washable goods so that they can be double checked to ensure
quality.
12. Check garment with right machine, tools and equipment’s and in right conditions.
13. Inspect the right ironing or pressing, folding techniques.
14. Make repeat inspection of garments prior to poly-bagging.
15. Inspect poly-bagging & assortment.
16. Make sure the actual measurements of carton and complete packaging process according to the
buyer requirements.
17. Manufacturer conducts final inspection in prior to shipment of garment.
18. Transmit training quality assurance personnel so that they can easily identify defects & understand
the causes of defects.
19. Also arrange training for quality assurance (QA) personnel on Statistical Methods.
20. Make continuous improvement plans & implement them.
Conclusion
The term quality cannot be confined to one definition. It is tensile in nature and 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.
1) When it comes in context of Pharma then Quality is a legal issue and must be maintained in
pharmaceutical products.
2) When it comes in context of Garment/Textile then Quality is a set of issues i.e comfort, sustainable,
price, fashion and must be maintained in competitive global market