Quality Management Practices in Pharma Sector

Domain: Pharma Industry

Companies: GSK Pharma, Sun Pharma

I. TQM in Pharmaceutical Industry
• The pursuit of quality aimed at prevention of defects rather than detection of defects

• Quality must be built into a pharmaceutical product during product and process design
and it is influenced by the physical plant design, space, ventilation, cleanliness and
sanitation during routine production

• The assurance of quality of the product depends on more than just proper sampling and
adequate testing of various components and finished dosage forms (products)

• Prime responsibility of maintaining the product quality during production rests with the
manufacturing department.

• Quality assurance personnel must establish control or check points to monitor the quality
of the product as it is processed and up to completion of manufacturing.

• This begins with raw materials and component testing and includes in-process packaging,
labeling and finished product testing as well as batch auditing and stability monitoring

• The concept of quality assurance and quality control develops and follows standard
operating procedures (SOP) directed towards assuring the quality, safety and efficacy.

• World Health Organization (WHO) has issued a primary or fundamental regulation to

pharmaceutical industries entitled good manufacturing practice (GMP) for
pharmaceuticals.

• Based on WHOGMP, many countries have formulated their own requirements for GMP.

• In USA, as the Food and Drug Administration (FDA) has a mandate that the marketed drug
product be safe effective, the drug product must meet certain criteria for quality and
purity.

• The FDA has issued regulatory guidelines known as current good manufacturing practice
(cGMP) and good laboratory practice (GLP) to assure the public that the marketed drug
product has been properly manufactured and clinically tested respectively.

• According to FDA regulations, a drug product that does not meet the GMP requirements
is considered unacceptable

II. The eight dimensions of quality, which is a critically important ingredient

to organizational success, are as follows:
1. Performance: Product’s primary operating characteristics

2. Features: Supplements to a product’s basic functioning characteristics

 3. Reliability: A probability of not malfunctioning during a specified period

4. Conformance: The degree to which a product’s design and operating characteristics meet
established standards

5. Durability: A measure of product life

6. Serviceability: The speed and ease of repair

7. Aesthetics: How a product looks, feel, tastes and smells

8. Perceived quality: As seen by a customer

III. Guidelines of the Pharmaceutical Quality

1. WHO guidelines
WHO has published a handbook on the GMP in particular, entitled: Quality assurance of
pharmaceuticals, a compendium of guidelines and related materials Volume 2: good
manufacturing practices and inspection (Quality Assurance of Pharmaceuticals, 2004).

It consists of 4 chapters:

Chapter 1: WHO GMP: main principles for pharmaceutical products.

Chapter 2: Good manufacturing practices: starting materials.

Chapter 3: Good manufacturing practices: specific pharmaceutical products.

Chapter 4: Inspection.

And 7 annexes:

Annex 3: Radiopharmaceutical products.

Annex 4: Good manufacturing practices for pharmaceutical products: main principles.

Annex 5: Model Certificate of GMP.

Annex 6: Sterile pharmaceutical products.

Annex 7: Guidance on GMP inspection.

Annex 8: Pre-approval inspection.

Annex 9: Quality system requirements for national GMP inspectorates.

2. FDA guidelines
• A Risk Based Approach; the initiative outlines immediate, near and longer-term stages that
FDA believes will take two years to be implemented

• On the technical side, FDA states three concepts that will guide the reevaluation process:
 Advances in risk management science
 Advances in quality management science and
 Advances in pharmaceutical science and manufacturing technology

• The most important guidelines are Code of Federal Regulation 210, 211.

 21CFR Part 210: The regulations contain the minimum current good manufacturing
practice for methods to be used in, and the facilities or controls to be used for, the
manufacture, processing, packing, or holding of a drug to assure that such a drug
meets the requirements of the act as to safety, and has the identity and strength and
meets the quality and purity characteristics that it claims to possess.

 21CFR Part 211: The regulations in this part contain the minimum current good
manufacturing practice for preparation of drug products for administration to humans
or animals. The FDA has concluded that modern quality systems together with
manufacturing processes and product knowledge, can handle many types of changes
to facilities, equipment and processes without the need for regulatory submission.

3. EU guidelines
• The core of European Union legislation in the pharmaceutical sector is gathered in Volume 1
and Volume 5 of the publication; ‘‘The rules governing medicinal products in the European
Union’’.

• Volume 1 – EU pharmaceutical legislation for medicinal products for human use.

• Volume 5 – EU pharmaceutical legislation for medicinal products for veterinary use.

• The basic legislation is supported by a series of guidelines that are also published in the
following volumes of ‘‘The rules governing medicinal products in the European Union’’:

• Volume 2 – Notice to applicants and regulatory guidelines for medicinal products for human
use.

• Volume 3 – Scientific guidelines for medicinal products for human use.

• Volume 4 – Guidelines for good manufacturing practices for medicinal products for human
and veterinary use.
• Volume 6 – Notice to applicants and regulatory guidelines for medicinal products for
veterinary use.

• Volume 7 – Scientific guidelines for medicinal products for veterinary use.

• Volume 8 – Maximum residue limits.

• Volume 9 – Guidelines for pharmacovigilance for medicinal products for human and
veterinary use.

• Volume 10 – Guidelines for clinical trial.

4. ICH guidelines
• The International Conference on Harmonization of technical requirements for registration of
pharmaceuticals for human use (ICH) is a special project that gathers the regulatory
authorities of Europe, Japan and the United States and experts from the pharmaceutical
industry in the three different regions; to discuss scientific and technical aspects of product
registration.

• The objective of such harmonization is a more efficient use of human, animal and material
resources, and the removal of any delay that is not essential in the global development and
availability of new medicines while maintaining safeguards on quality, safety and efficacy,
and regulatory obligations to protect public health.

IV. General practices recently applied in the Pharmaceutical Industry

Quality management in the drug industry In the drug industry at large, quality management is
usually 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: — an appropriate infrastructure or “quality system”, encompassing the
organizational structure, procedures, processes and resources; — systematic actions necessary
to ensure adequate confidence that a product (or service) will satisfy given requirements for
quality. The totality of these actions is termed “quality assurance”. Within an organization,
quality assurance serves as a management tool. In contractual situations, quality assurance also
serves to generate confidence in the supplier. The concepts of quality assurance, GMP and quality
control are interrelated aspects of quality management. They are described here in order to
emphasize their relationship and their fundamental importance to the production and control of
pharmaceutical products.

1. Quality assurance
Principle. “Quality assurance” is a wide-ranging concept covering all matters that individually or
collectively influence the quality of a product. It is the totality of the arrangements made with
the object of ensuring that pharmaceutical products are of the quality required for their intended
use. Quality assurance therefore incorporates GMP and other factors, including those outside
the scope of this guide such as product design and development.

The system of quality assurance appropriate to the manufacture of pharmaceutical products

should ensure that:

(a) pharmaceutical products are designed and developed in a way that takes account of the
requirements of GMP and other associated codes such as those of good laboratory practice (GLP)
and good clinical practice (GCP);

(b) production and control operations are clearly specified in a written form and GMP
requirements are adopted;

(c) managerial responsibilities are clearly specified in job descriptions;

(d) arrangements are made for the manufacture, supply and use of the correct starting and
packaging materials;

(e) all necessary controls on starting materials, intermediate products, and bulk products and
other in-process controls, calibrations, and validations are carried out;

(f) the finished product is correctly processed and checked, according to the defined procedures;

(g) pharmaceutical products are not sold or supplied before the authorized persons (see also
sections 9.11 and 9.12) have certified that each production batch has been produced and
controlled in accordance with the requirements of the marketing authorization and any other
regulations relevant to the production, control and release of pharmaceutical products;

(h) satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products
are stored by the manufacturer, distributed, and subsequently handled so that quality is
maintained throughout their shelf-life;

(i) there is a procedure for self-inspection and/or quality audit that regularly appraises the
effectiveness and applicability of the quality assurance system;

(j) deviations are reported, investigated and recorded;

(k) there is a system for approving changes that may have an impact on product quality;

(l) regular evaluations of the quality of pharmaceutical products should be conducted with the
objective of verifying the consistency of the process and ensuring its continuous improvement.

The manufacturer must assume responsibility for the quality of the pharmaceutical products to
ensure that they are fit for their intended use, comply with the requirements of the marketing
authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The
attainment of this quality objective is the responsibility of senior management and requires the
participation and commitment of staff in many different departments and at all levels within the
company, the company’s suppliers, and the distributors. To achieve the quality objective reliably
there must be a comprehensively designed and correctly implemented system of quality
assurance incorporating GMP and quality control. It should be fully documented and its
effectiveness monitored. All parts of the quality assurance system should be adequately staffed
with competent personnel, and should have suitable and sufficient premises, equipment, and
facilities.

2. Good manufacturing practices for pharmaceutical products (GMP)

Good manufacturing practice is that part of quality assurance which ensures that products are
consistently produced and controlled to the quality standards appropriate to their intended use
and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks
inherent in any pharmaceutical production. Such risks are essentially of two types: cross-
contamination (in particular of unexpected contaminants) and mix-ups (confusion) caused by, for
example, false labels being put on containers. Under GMP:

(a) all manufacturing processes are clearly defined, systematically reviewed in the light of
experience, and shown to be capable of consistently manufacturing pharmaceutical products of
the required quality that comply with their specifications;

(b) qualification and validation are performed;

(c) all necessary resources are provided, including:

(i) appropriately qualified and trained personnel;

(ii) adequate premises and space;

(iii) suitable equipment and services;

(iv) appropriate materials, containers and labels;

(v) approved procedures and instructions;

(vi) suitable storage and transport;

(vii) adequate personnel, laboratories and equipment for in-process controls;

(d) instructions and procedures are written in clear and unambiguous language, specifically
applicable to the facilities provided;

(e) operators are trained to carry out procedures correctly;

(f) records are made (manually and/or by recording instruments) during manufacture to show
that all the steps required by the defined procedures and instructions have in fact been taken
and that the quantity and quality of the product are as expected; any significant deviations are
fully recorded and investigated;

(g) records covering manufacture and distribution, which enable the complete history of a batch
to be traced, are retained in a comprehensible and accessible form;

(h) the proper storage and distribution of the products minimizes any risk to their quality;

(i) a system is available to recall any batch of product from sale or supply;

(j) complaints about marketed products are examined, the causes of quality defects investigated,
and appropriate measures taken in respect of the defective products to prevent recurrence.

3. Sanitation and hygiene

A high level of sanitation and hygiene should be practised in every aspect of the manufacture of
drug products. The scope of sanitation and hygiene covers personnel, premises, equipment and
apparatus, production materials and containers, products for cleaning and disinfection, and
anything that could become a source of contamination to the product. Potential sources of
contamination should be eliminated through an integrated comprehensive programme of
sanitation and hygiene.

4. Complaints
Principle. All complaints and other information concerning potentially defective products should
be carefully reviewed according to written procedures and the corrective action should be taken.
A person responsible for handling the complaints and deciding the measures to be taken should
be designated, together with sufficient supporting staff to assist him or her. If this person is
different from the authorized person, the latter should be made aware of any complaint,
investigation or recall.

There should be written procedures describing the action to be taken, including the need to
consider a recall, in the case of a complaint concerning a possible product defect. Special
attention should be given to establishing whether a complaint was caused because of
counterfeiting.

Any complaint concerning a product defect should be recorded with all the original details and
thoroughly investigated. The person responsible for quality control should normally be involved
in the review of such investigations. If a product defect is discovered or suspected in a batch,
consideration should be given to whether other batches should be checked in order to determine
whether they are also affected. In particular, other batches that may contain reprocessed
product from the defective batch should be investigated. Where necessary, appropriate follow-
up action, possibly including product recall, should be taken after investigation and evaluation of
the complaint.

All decisions made and measures taken as a result of a complaint should be recorded and
referenced to the corresponding batch records. Complaints records should be regularly reviewed
for any indication of specific or recurring problems that require attention and might justify the
recall of marketed products. The competent authorities should be informed if a manufacturer is
considering action following possibly faulty manufacture, product deterioration, counterfeiting
or any other serious quality problems with a product.

5. Product recalls
There should be a system to recall from the market, promptly and effectively, products known or
suspected to be defective. The authorized person should be responsible for the execution and
coordination of recalls. He/she should have sufficient staff to handle all aspects of the recalls with
the appropriate degree of urgency. There should be established written procedures, which are
regularly reviewed and updated, for the organization of any recall activity. Recall operations
should be capable of being initiated promptly down to the required level in the distribution chain.
An instruction should be included in the written procedures to store recalled products in a secure
segregated area while their fate is decided.

6. Quality risk management:

• All products and all processes have an inherent element of risk.

• In an organization that is intending to apply an effective quality risk management approach,

a clear definition of what is considered ’’risk’’ should be agreed upon because of the too many
stakeholders in the pharmaceutical industry and their corresponding diverse interests.

• The FDA has noticed that it needs to reorganize its procedures and processes to merge the
use of risk management programs (RMP) within the agency and within the industries it
regulates. Consequently, the FDA has started publishing position papers and guidelines on
what it expects to see in an RMP.

• Risk management plans should be used to identify risk.

• Quality Risk Management is defined as a method for the assessment, control, communication
and review of risks to the quality of the drug (medicinal) product through the product lifecycle
where decisions can occur at any point in the process.

• In the guideline entitled Medical Device Use-Safety: incorporating human factors engineering
into risk management; it clarifies how hazards related to medical device use should be
directed during device development as part of the risk management process.
7. Quality by design:
• ICH Q8 defines design space from the concept that quality cannot be tested into product
but has to be built in by design

• Based on the ICH Q8; which concerns pharmaceutical development with targeting
designing quality into the ingredients, formulation and manufacturing process to deliver
the intended performance of the product

• Design space is presented by the applicant and is subject to regulatory assessment and
approval

• In these situations, opportunities exist to develop more flexible regulatory approaches.

The design and conduct of pharmaceutical development research should be consistent
with their intended scientific purpose.

8. Corrective action and preventive actions

• QMS nonconformities and other system deficiencies, including legal noncompliance,
should be analyzed to detect patterns or trends. Identifying trends allows the
manufacturer to anticipate and prevent future problems.

• The organization should focus on correcting and preventing problems. Preventing

problems is generally cheaper than fixing them after they occur. The organization should
also start thinking about problems as opportunities to improve.

• ‘‘Root cause analysis’’ is a process by which the manufacturer can identify causes and
preventive actions.

• In general, CAPA experts recommend that root-cause investigations follow a four-step

process:

 Identify the problem

 Evaluate its magnitude, which includes assessing risk
 Investigate and assign responsibility
 Analyze and document the root cause of the problem

• For example a new corrective action tracking system had helped Alcon Laboratories Inc.
unite its many corrective and preventive action systems worldwide resulting in faster time
of closure on corrective action, both access and speed to information are much greater
and finally quality professionals are able to focus on more important issues.

9. Process capability analysis

• Process capability is the comparison of the ‘‘Voice of the Customer’’ (VOC) with the ‘‘Voice
of the Process’’ (VOP). VOC, which is built on customer requirements, is defined by the
 specification limits of the process, which are fixed, while VOP is defined by control limits,
which are based on performance data and vary over time

• Metrics such as capability index namely Cp and Cpk were developed several years ago to
calculate this comparison between control and specification limits

The capability index a ratio that compares process spread to tolerance spread and results
in a single number. It is a management tool which is used to compare process
performance

10.Six Sigma
• Six Sigma is a business process that enables companies to increase profits dramatically by
streamlining operations, improving quality, and eliminating defects or mistakes in
everything a company does

• It can help an organization reduce defects and improve profitability using several basic
tenets

• Six Sigma Projects are based on the DMAIC model

• The DMAIC model is the generic model of six sigma methodology. It is an acronym that
stands for; Define, Measure, Analyze, Improve and Control.

• Sometimes this model includes recognize as an awareness item to the model. Each of the
components addresses a different aspect of the overall improvement and breakthrough
strategy

11.Process analytical technologies

• Process analytical technologies (PAT); play a key role in enabling ‘‘quality by design’’ and
scientific aspect of manufacturing.

• PAT’s main aim is to understand and control the manufacturing process through the
application of integrated chemical, physical, microbiological, mathematical and risk
analysis methods.

• PAT has been applied in non-Pharma industries for many years, yielding cost savings and
manufacturing efficiencies.

• The implementation of process analytical technology (PAT) is bringing lots of benefits and
improvements for many pharmaceutical processes.

• The benefits are lower production cycle times, improved manufacturing efficiency,
reduced rejects and increased production operating time

• Within pharmaceutical industry, there have been a number of successful PAT-based

comparability protocol submissions, ranging from single-unit operation application at
 GlaxoSmithKline to a more all-including application covering both drug substance and
drug product at Sanofi-Aventis

V. Pharma Industry in India

• The pharmaceutical sector was valued at US$ 33 billion in 2017. The country’s
pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015–20
to reach US$ 55 billion

• India’s pharmaceutical exports stood at US$ 17.27 billion in FY18 and have reached US$
19.14 billion in FY19

• Pharmaceutical exports include bulk drugs, intermediates, drug formulations, biologicals,

Ayush & herbal products and surgicals

VI. Major bodies regulating drugs and pharmaceuticals in India

The principal regulatory bodies entrusted with the responsibility of ensuring the approval,
production and marketing of quality drugs in India at reasonable prices are:

1. The Central Drug Standards and Control Organization (CDSCO):

• Located under the aegis of the Ministry of Health and Family Welfare.

• The CDSCO prescribes standards and measures for ensuring the safety, efficacy and
quality of drugs, cosmetics, diagnostics and devices in the country; regulates the market
authorization of new drugs and clinical trials standards; supervises drug imports and
approves licences to manufacture the above-mentioned products;

2. Controller General of India (DCGI)

• Issues related to industrial policy such as the regulation of patents, drug exports and
government support to the industry are governed by the Department of Industrial Policy
and Promotion and Directorate General of Foreign Trade, both under the aegis of Ministry
of Commerce and Industry and the Ministry of Chemicals and Fertilizers.

• With respect to licencing and quality control issues, market authorization is regulated by
the Central Drug Controller, Ministry of Health and Family Welfare, Department of
Biotechnology, Ministry of Science and Technology (DST) and Department of
Environment, Ministry of Environment and Forests.
 • State drug controllers have the authority to issue licences for the manufacture of
approved drugs and monitor quality control, along with the Central Drug Standards
Control Organization (CDSCO).

VII. TQM at Sun Pharma

Sun Pharmaceutical Industries Limited including its subsidiaries and associates (Sun Pharma) is
the fourth largest global specialty generic company that is ranked No. 1 in India and No. 8 in the
US. It is the largest Indian pharmaceutical company in the US and among the leading Indian
pharmaceutical companies in emerging markets.

Sun Pharma enjoys a vertically integrated business, economies of scale and good talent
management practices that enable it to deliver quality products at affordable prices. The
Company is deepening its global footprint as a highly trusted manufacturer of specialty products,
branded generics, complex and pure generics, OTC products, anti-retrovirals (ARVs) and APIs.

It is expanding its footprint among consumers and healthcare professionals in 100+ countries,
and offers a portfolio of 2,000+ products, globally, in a full range of dosage forms. This includes
tablets, capsules, injectables, ointments, creams and liquids, nasal sprays and hormones, among
others.

Sun Pharma has 44 manufacturing sites approved by global health regulatory agencies—
supported by a worldwide supply chain—and multiple research and development (R&D) facilities
across the world, investing 6.9% of its sales in R&D. It has a diverse employee base of 32,000+
individuals across 50 nationalities worldwide.

• Quality is considered paramount at all locations where we conduct regulated research,

development, manufacture, testing and distribution of pharmaceutical products

• The operations are driven by best-in-class technology and processes, abiding by all major
stringent regulatory approvals

• The commitment to implementing a robust global quality management system is based

on determination to sustain a culture of operational excellence, meeting and exceeding
the expectations of all stakeholders, including patients, customers and regulators
 • The global Quality Management Team ensures that every product manufactured and
distributed by us complies with all internationally accepted good practices and standards
of quality, purity, efficacy and safety

• To maintain quality standards, every plant has well defined procedures and systems in
place in compliance with the requirements of the Current Good Manufacturing Practices
(cGMP), WHO, PIC’s and EU GMP in order to ensure that the operating procedures meet
the very exacting standards of regulators like the US FDA, EMA, HC, WHO and TGA, among
others

The annual report of 2019 for Sun Pharmaceutical Industries Ltd. States that:

Quality adherence:

Quality is sacrosanct at all Sun Pharma R&D centres, manufacturing units and testing and
distribution facilities. The Company is committed to implementing a robust quality management
system and sustains a culture of operational excellence and meeting and exceeding stakeholder
expectations. Sun Pharma believes in the motto of ‘putting patients first’ and its global Quality
Management Team ensures every product complies with internationally accepted good practices
and standards of quality, purity, efficacy and safety.

The Company has put stringent checks in place to conform to global quality standards and
ensures compliance with the requirements of various regulators. It has cGMP certifications from
various global regulatory authorities like USFDA, EMA, WHO and TGA, among others.

Sun Pharma has well-trained personnel for quality control at each site, who, along with a
regulatory affairs department, ensure strict adherence to quality systems and procedures. The
teams are guided by a Corporate Quality Unit, which oversees the translation of the latest GMP
updates to guidelines, standard operating procedures (SOPs) and protocols. The Company’s
manufacturing plants are audited by an autonomous Corporate Compliance Department to set
up 24x7 compliance and conformance.

Going ahead, Sun Pharma will continue to ensure 24x7 compliance to cGMP as an imperative for
a global business. It will continue to enhance systems, processes Global manufacturing footprint
Formulation plant API plant API and Formulation plant Latrobe (Australia) Port Fairy (Australia)
Lagos (Nigeria) Be-Tabs (South Africa) Tennessee (USA) Billerica MA (USA) Wilmington MA (USA)
Ontario (Canada) New Jersey (USA) Cranbury (USA) Giza (Egypt) Haifa (Israel) Tiszavasvari
(Hungary) Cluj (Romania) Gazipur (Bangladesh) Saitama (Japan) (2 units) Kuala Lumpur (Malaysia)
Penza (Russia) Karkhadi Baddi Jammu Paonta Toansa Mohali Baska Halol Dahej Silvassa
Ankleshwar Panoli Malanpur Ahmednagar Dadra Goa Maduranthakam Guwahati Dewas Sikkim
(2 units) and human capabilities to ensure compliance with global regulatory standards.
During the year, the USFDA granted an EIR to the Company’s Halol facility, thus lifting the warning
letter issued to the facility in 2015. Post the receipt of the EIR, the Company has started receiving
new approvals from USFDA for the US market.

Regulatory compliance in pharmaceutical manufacturing

Regulatory standards for pharmaceutical facilities have been undergoing constant upgradation
over the past many years, with regulatory agencies demanding the highest quality products. To
adhere to these stringent standards, pharmaceutical companies need to have an unwavering
focus on 24x7 compliance, which, in turn, raises compliance costs. Ensuring that each
manufacturing facility remains compliant has become a key priority for pharmaceutical
companies worldwide.

During the year, many of our facilities underwent successful audits by multiple regulatory
agencies, including the USFDA. Our Halol facility, which was impacted by cGMP deviations in
FY15, was cleared by the USFDA in June 2018. With this clearance, new approvals from this facility
for the US market have started coming through gradually

VIII. TQM at GSK

GlaxoSmithKline (GSK) was formed from the December 2000 merger of Glaxo Welcome and
SmithKline Beecham plc. The $70 billion deal created the world's largest drug manufacturer and
research-based pharmaceutical concern.

 They supply products to 191 global markets

 Produce over 1,200 different brands
 Manufacture 4 billion packs per year
 Produce over 28,000 different finished packs per year
 Supply 6,900 tonnes of bulk active each year
 Manage 2,000 new product launches globally each year
TOTAL QUALITY (TQM) AT GSK:

TQM Basis
The concept of management of quality control embarked during 1920, it remained unknown in
western world, as it achieved outstanding results in Japan until 1980s. TQM approach is highly
based on long term success mainly focusing on customer satisfaction. The core purpose of TQM
is to maintain quality that is an ultimate purpose of any organization which aims at designs and
effective processes. Improving quality enables organization to restore prevented activities and
brings about change with the passage of time, as the change has been major need of any
company’s product or service.

The concept of continuous improvement by TQM

Continuous improvement is believed to improve the operations that are closely associated to the
workers on the floor, who can determine the need of change, because employees are more
indulged with continuous programs. In order to maintain maximum quality of products and
services change/continuous improvement plays important role because it opens the door to
grow the business and maintains the stability. According to GSK, if a side of business faces the
challenges then other branch can recover its overall profit.

Steps to creating a total quality management system:

GSK pursues sturdy quality management process, it basically go after TQM to give finest product
with SIX SIGMA which makes it certain with zero error. GSK cannot take risk as it provides food
and drugs, GSK vigilantly selects its suppliers and scrutinize from beginning to end because it has
to sustain utmost quality of a product.
1. Simplify vision, mission and values
The organizational strategy and objectives are linked with the employees’ work they do.
Employees must understand the way of organization it is heading (vision). What it aims to achieve
(mission) and create specific rules and regulations (values) which will guide the requirements and
control. Initiate the process to enhance employee’s awareness when new workers orientation
takes place which engages employee directly with Vision, Mission, and values.

2. Identify critical success factors (CSF)

Critical success factors are very useful or the organization which aims at attaining the objective
and to achieve the mission. It helps the company to keep everything monitored and updated that
how efficiently the organization’s objectives are met. There are some examples of CSF below:

 Financial Performance
 Customer Satisfaction
 Process improvement
 Market Share
 Employee Satisfaction
 Product Quality

3. Develop Measures and Metrics to Track CSF Data

As the factors are acknowledged it then requires to measure to be placed and continuously
monitored and tracked the improvement. It is possible when employees share the collected data
with seniors. For Instance: if a core objective is to increase consumer satisfaction survey scores,
the major purpose should be considered and measures to exhibit action of the goal.

4. Identify key customer group

When the organization is built they have only one focus that how to attract the customers, in this
era mostly those organizations are succeed which understand who the targeted customers are,
so that they can provide products and services as per customer’s requirements. The organization
fails to achieve the mission because it ignores the key customer group. Examples of key
customers group: Employees, Customers, Suppliers, Vendors and Volunteers.

5. Solicit Customer Feedback

Organization comes to know through one way, they directly ask them question regarding their
requirements that whether the product is needed to be improved; the structured feedback
implies that what a customer wants and what is important to them. One thing an organization
must highlight to avoid that they know what their customer wants and ask them wrong questions
while taking feedback.

6. Develop Survey Tool

Now build up the customer satisfaction survey tool which virtually figures out what is important
to customers. For instance: customers are more concerned about the quality than the cost if the
organization focus on reducing the price and compromising on quality that you are creating the
product which will not satisfy the customer requirement.

7. Survey each customer group

A survey should be arranged for each customer group in order to have insight regarding
customers’ perception as prime data. This data could help us to have clear points for
improvement will enable to demonstrate progress and improvement plans are executed.

8. Develop Improvement Plans

As the baseline data is gathered, improvements plan are supposed to be developed according to
the reaction of each customer group during survey. Improvement plans must be designed as
SMART goals. Goals may include some of the following:

 Process improvement initiatives, I.e. Hold gap during customer call duration.
 Leadership growth, walk-the-talk.
 Management Training & Development: procedure to deal with employees in quality
horizon.
 Employees Training & Development: Customer Services.
 Performance Management: Estimating the limit of expectation leading towards creating
jobs description that maintains stability to keep vision clear and make employees to
accept responsibility.

9. Resurvey
A review should be held after a passage of time (12-18 months) in order to recognize the level of
key customer’s needs enhancement, customer’s needs and requirements tend to be fickle, so for
the success of organization consistent improvement is important factor.

10. Monitor CSF

Monthly Monitoring plays vital role to ensure that the consistent improvement towards goals is
achieved. This helps us to make corrections and change precedence and objectives while
reviewing as per requirement of customers.
11. Incorporate Satisfaction Data into Marketing Plans
When the desired results are achieved, which is meeting the requirements of your data collected
during feedback and survey, should be used as promotion tool. Many successful organizations
lose opportunities by hiding what they do well. Customers are always curious about internal
process work, which can provide outstanding results.

12. Technology
It is necessary to ensure that the technology is uncomplicated and aims to achieve desired
improvements. For instance: web surfing have got to be trouble-free to use and as much easier
to access (SEO) and the content should be précised and specific.

TQM METHODOLOGY APPLIED

1. In Global Manufacturing and Supply (GMS), Lean Six Sigma was delivering solid and quantifiable
business improvements.

2. In the Consumer Healthcare business, Project Management was noticeably improving the
execution of projects.

3. And across the company OD teams were driving higher levels of engagement and effective
change.

Journey of Accelerating Delivery and Performance (ADP)

A small team was formed with the CEO’s sponsorship in 2009 to identify some simple approaches
drawn from Organization Development (OD), Lean Six Sigma and Project Management. The
fusion of these approaches became ADP.

At the heart of ADP is a set of six core principles for accelerating change:

 All change starts with self.

 Active, committed and visible sponsorship by key stakeholders is imperative.
 Ensure that simple, time-bound measures tied to financial results.
 Include people who are impacted by change to own and design it.
 Focus on the few vital things that you can change now.
 Design fit for purpose solutions that address customer needs, not wants.

Applying the OD cycle–as the ADP team engaged with the customers, a clear diagnosis of the
current state of each project was established as the start of a consulting cycle working around
the GSK Change Framework. This defined business problems and opportunities for sustainable
improvements– all with a keen eye on value for the external customer and patient. Based on this,
GSK apply a “Forum, Fieldwork, Feedback” approach. In a series of ‘Forum’ workshops, intact
teams are taught the change framework approaches and get to apply them immediately to their
real work; in the ‘fieldwork’ between workshops they are coached and observed in applying their
new-found knowledge, providing them with critical ‘feedback’.

The future of ADP

The program continues with an ambition of bringing the rigor of ADP to the whole of GSK over
the next 3-5years. It will continue to adapt and evolve. The challenge moving forward is to embed
and sustain the new capabilities and continue to realize tangible benefits. To achieve this, GSK
continues to operate a ‘pull’ based approach. Once a business unit starts believing the new ways
of working, they are encouraged to invest in their own (small) team of consultants to establish
the new ways of working as the new system.

OTHER TQM TECHNIQUES APPLIED IN GSK

1. Quality Planning

The overall planning can be summarized as the following steps:

 Customer needs
 Forecast the future.
 Gap- analysis.
 Closing the loop holes.
 Alternatives Evaluation.
 Implementation.

These steps are used to identify the gaps and set SMART objectives to measure it through PDCA.

2. Quality Council

The organization has formed a different quality department and circles to assure the quality at
every process. Develop the quality-based core values, vision statement and quality policy
statement.

3. Design the long-term strategic plan with annual goals for quality improvement programs and
objectives.
4. Establish total education and training plan and procedure.
5. Continually monitor and update with the help of best practices.
6. Determine the measures that are the performance measures for organization with
coordination with different organizational functional areas.
7. Unwavering focus on the issues regarding external and internal customers. Develop a system
to solve those problems.
8. Monitor and revise the benchmarks to remain updated. Look for certifications and
recognition for the best practices followed in the organization.

Quality Cost
Comparing with the companies in the industry that is evaluating the alternatives for doing the
same job with low cost. Focusing to attain maximum results at individual level so that the quality
gets ensured from the beginning. Creating relationships among the cost categories – linking the
cost drivers to minimize the cost.

ENVIRONMENTAL MANAGEMENT SYSTEM

GSSK has always shown strong commitment and support for public health, awareness and many
social causes. GSK does not have a fixed budget for CSR because they believe in funding as many
deserving charities & NGOs as possible. It focuses on improving health and education.

QFD AT GSK
The QFD model basically concerned with two departments at GSK

1) Manufacturing Department and

2) Commercial Department.

The manufacturing department helps in identifying technical descriptors i.e. material and process
required for making a product, and commercial department helps in identifying customer
requirements. Commercial department also measure level of GSK`s customer`s satisfaction by
different means periodically.

BENCHMARKING
The quality department at GSK has established certain criteria for benchmarking its performances
which set at global level and implemented in every country. They have set their own standards
by integrating ISO standards. They follow WHO, FDA, TGA standards align with GSK global
standards.

QUALITY MANAGEMENT SYSTEM

The Quality Management System (QMS) is designed to support the GSK quality statement. It
provides a framework that ensures quality, regulatory compliance, product safety, and efficacy
and support continuous improvement at GSK. The whole system is centrally managed which is
published on GSK intranet and implemented at sites through local SOP (standard operating
procedures) systems. At GSK SOPs implement QMS locally and comply with the Global Quality
Policy requirements.

CUSTOMER COMPLAINTS
At GSK they have developed a system for handling customer complaints called `COMPLAINT
HANDLER`. The system works in following manner. First, it investigates customer`s past
experience, secondly, they analyze the customer complaint. Thirdly they develop complaint
resolution procedure accordingly. And finally identify process and material variation and then
work to eliminate the root cause. At GSK a department called COMMERCIAL DEPARTMENT is also
established that deals and identifies customer expectations and their satisfaction and constantly
monitors them. They tend to act on customer complaints within 24 hours.

RISK MANAGEMENT
At GSK there is very big section for Risk Management Processes, who carry out the risk
management of all operational, financial and manufacturing activities. There is a board called
(RMCB) Risk Management Compliance Board that aids, instructions and procedures to the risk
management committee for identifying problems related to the following:

 Machine Maintenance Production Volume Product Labeling Working instruction and

conditions.
 They also analyze the impact of each risk in short term and long term both and after
analyzing they rate each risk on the basis of their type (minor or major) and on the basis
of their impact in short and long term, the rating is done globally at GSK.

QUALITY MONTH
At GSK they use to make QUALITY MONTH once in a year to promote a culture towards total
quality management. During this month new tools or improved tools are used for bringing in and
assuring more and more quality everywhere within the organization. Several interactive sessions
take place and all employees and senior management share their findings and their solutions
which ultimately promote a culture towards quality.

PERIODIC PRODUCT REVIEW

It is their prior responsibility to review their products annually. The process of reviewing the
products includes tools like STATISTA. They have software called LIMPS. SYSTEM in which all the
product reviews are saved. All the past data saved in it and thus they can easily compare that
where they were last year and where they stand today.
EMPLOYEE TRAINING & AWARD SYSTEM
Before an employee joins the organization, he is fully trained about his work and the culture of
the organization. After training an audit and only then he can join the organization. Recognition
is given to employees by giving titles such as “EMPLOYEE OF THE MONTH”. Besides this monthly
activity they also give ERA awards everywhere.

EMPLOYEE SUGGESTION SYSTEM

GSK is open to accept any recommendation and suggestion from their employees. Annually
appraisal is done at the beginning of every year in which targets given to each employee are
matched with its performance. It is done for:

 Basis for Reward (Increment Bonus)

 Basis for Promotion
 Placement
 Training And Development

References:

https://sunpharma.com/sites/default/files/annual/Complete%20Annual%20Report.pdf

https://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.p
df

https://www.sciencedirect.com/science/article/pii/S1319016413001114

https://be.gsk.com/en/careers/areas-of-opportunity/quality/

https://www.gsk.com/en-gb/careers/apprentices-students-and-graduates/future-leaders-graduate-
programme/manufacturing-operations-and-quality-vaccines/

https://www.pharmaguideline.com/2018/03/total-quality-management-tqm.html

http://www.sphinxsai.com/Vol.3No.1/pharm_jan-mar11/pdf/JM11(PT=63)%20pp%20365-375.pdf

https://www.researchgate.net/publication/291339350_Total_Quality_Management_of_Pharmaceutical
s_Recent_Approaches_and_Advancements

https://www.asianpharmtech.com/articles/total-quality-management-the-need-ofthe-hour-for-
pharmaceutical-industry.pdf