Quality control measures in pharmaceutical industry

QUALITY CONTROL MEASURES IN PHARMACEUTICAL INDUSTRY

PRESENTED BY:NUPUR APURVA PURVA MAYURI SHWETA

CONTENTS1. QUALITY CONTROL2. ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY3. OBJECTIVES OF QUALITY CONTROL4. STEPS IN QUALITY CONTROL5. COST OF QUALITY CONTROL6. TOTAL QUALITY MANAGEMENT7. QUALITY CIRCLE

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DEFINITION OF QUALITY CONTROL • Quality as defined by Juran is fitness for purpose or use. It refers

to the features and characteristics of a product that bears on its ability to satisfy the needs of the consumer. Features like shape, dimension, composition, strength, workmanship , finish and colour.

• According to Broom, quality control is “systematic control of these variables encountered in manufacturing process which affect the excellence of the end product.”

• According to Alford and Beatty, quality control is “that technique or group of techniques of industrial management by means of which products of uniform acceptable quality are manufactured.”

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ATTRIBUTE QUALITY ASSURANCE QUALITY CONTROL

Definition QA is a set of activities for ensuring quality in the processes by which products are developed

QC is a set of activities for ensuring quality in products. The activities focus on identifying defects in the actual products produced.

Focus QA aims to prevent defects with a focus on the process used to make the product. It is a proactive quality process.

QC aims to identify (and correct) defects in the finished product. Quality control, therefore, is a reactive process.

Goal The goal of QA is to improve development and test processes so that defects do not arise when the product is being developed.

The goal of QC is to identify defects after a product is developed and before it's released.

As a tool QA is a managerial tool,QA is company based.

QC is a corrective tool,QC is lab based.

QUALITY ASSURANCE AND QUALITY CONTROL

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ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY

• Quality control is an essential operation of the pharmaceutical industry. • Drugs must be marketed as safe and therapeutically active formulations

whose performance is consistent and predictable.• New and better medicinal agents are being produced at an accelerated

rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation.

• The 4 Main responsibilities of quality control in pharmaceutical industry include :

Efficacy Safety Quality Compliance

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• Quality Control in the pharmaceutical industry is required for :

Raw Materials and API:The techniques used include Raman and IR spectroscopy, Assay( HPLC and Titration ), Physical tests.

Packaging Components :The various packaging components which are in contact with the drug are tested. The techniques include appearance, spectroscopy, loss on drying.

Finished Products :The techniques include HPLC, Assay, Dissolution, Content uniformity.

ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY

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QUALITY VARIATION

• When the quality of any drug is given by industry, then it is responsible for any variation from the standard. • Quality Variation may occur due to any mistake during the whole

process i.e. from the reception of raw material up to the final product in the packaged form.• The risk of error increases as the material increases and

the method become very complicated.

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• The general sources causing product Quality Variation during manufacturing are as follows:

QUALITY VARIATION

MATERIALS:a. Variations among suppliers of same

substances.b. Variations among batches from same

suppliers.c. Variations within a batch.

MACHINES:a. Variation of equipment of same

process.b. Difference in adjustments of

equipment.c. Aging of machines and improper care.

METHODS:a. Wrong procedure.

b. Inadequate procedure.c. Negligence in procedure by chance.

MEN:a. Improper working conditions.

b. Inadequate training and understanding.c. Lack of interest and emotional upheavals.

d. Dishonesty, fatigue and carelessness.

SOURCES OF VARIATION

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QUALITY VARIATION CONTROL• Material control.

Controlling each and every step of process can control variations.Control can be divided into:• Manufacturing practice control.• Packaging control.• Distribution control.

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MATERIAL CONTROL:• It starts just after the reception of materials. • Most of the materials that are active substances, excipients, packaging and

printed materials are received by the industry from suppliers. • Thus there should be adequate established system for the receipt, testing and

storage of all these supplies. • There should be a complete record of all the procedures and tests. In the

material following things are included:• Drug substances.• Excipients.• Packaging and printed materials.

QUALITY VARIATION CONTROL

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• After the reception of material, it is kept in a definite area. • Thus before laboratory testing, proper containers, labels, lot number, expiry dates etc

all are checked.• The material is stored in a proper way either they are arranged alphabetically or they

are differentiated depending upon physical nature. • Then samples are taken for laboratory testing and a label (Sampled) is fixed on

material.• In case of active constituents, percentage purity, adulteration, expiry date, lot

number, exact packing etc is checked.In case of printing and packaging material especially the color of label, weight of label and cartons and damage etc is checked.If the material is up to the mark, then a label (Passed) is pasted on it and it is placed at its proper place.On the other hand, if it is substandard, then it is kept in “Rejected Area” and sent back to the supplier.


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• MANUFACTURING PRACTICES CONTROL:Successful GMP is difficult to attain but to some extent, it can be modified and controlled. Specific procedures can be applied to attain the best quality.In case of manufacturing, following controls are important: Personnel. Equipment and building. Control of record. Production procedure control.

(A). PERSONNEL:Usually properly educated and well-trained persons should be in the industry. There should be proper selection and training in all departments i.e. production, packaging, labeling, etc, etc. There should be general lectures for less educated persons who work in the labeling or packaging section in an understandable language. They should be made aware of the fact that what is the importance of life saving. They should be warned about all the dangers of their mistakes and errors. There should be properly educated supervisors working above the workers. The supervisors should always be there so that in case of any trouble or question, they must be available. All the workers should be properly checked and all the processes at different steps should also be monitored by highly educated and experience persons who may not only be well qualified but experienced as well.


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• (B). EQUIPMENT AND BUILDING: The equipments and building used in storage, processing, checking and packaging should be of a suitable design, size, construction and location. In case of equipments, these should be constructed in a proper size and proper way. The size should be such that complete batch can be processed all at once. The surfaces of equipments should be non-reactive, non-absorptive and non-additive. The equipment should be constructed and fitted in such a way that it is easy to replace, easy to wash easy to operate and easy to empty. In case of building, there should not be any contamination i.e. the tablet and liquid section should be separated completely and even there should be complete separation in tablet machines. It means that machines should have separate cabinet.


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• (C) CONTROL OF RECORD: The records such as master formula record and batch production record must be maintained.

1. MASTER FORMULA RECORD:a. The master formula record must be prepared for each product.b. It must be signed by a competent and responsible person.c. The language must be so that it may not be miss-interpreted.d. It should be checked by another competent person and must be countersigned.e. The master formula varies from production to production and from batch to batch.f. Master formula record include the following information:i. Name of the product, dosage form and strength.ii. Complete list of ingredients including excipients.iii. Quality by weight or volume of each and every ingredient.iv. Standards or specifications of each ingredient.v. Any calculated excess of an ingredient.vi. Theoretical yield and termination of process.vii. Manufacturing and control instructions, specifications and precautions.viii. Complete description of closures, containers, labeling, packaging and other finishing material.


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• . BATCH PRODUCTION RECORD:a. Batch production record must be prepared, maintained and controlled for each batch of a product.b. It must be retained for about 5-years after product distribution.c. Batch production record should have following information in addition to master formula record.i. Batch number.ii. Code number.iii. Manufacturing date.iv. Expiry date.

(D). PRODUCTION PROCEDURE CONTROL:

The processes of manufacturing are operated according to the established rules from the reception of material up to delivery of final product. A complete list of ingredients along with their quantities is delivered to the Production Department. It is called Master Formula of that batch. It contains all the information of that batch i.e. procedures and equipments to be used and precautions to be taken, etc, etc. This master formula is taken into the store and all the materials for the batch are weighed and delivered to Production Department. All ingredients are rechecked and tested in laboratory. In the production procedure control, some tests are done during the process, which is called “In Process Quality Control (IPQC)” The IPQC is under Quality Control Department. Both Quality Control and Production Departments are responsible for the production procedure control.


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• PACKAGING CONTROL:

The packaging control is usually completed before manufacturing of product. When the product come in packaging section, it should be packed in recommended containers and there should not be any mistake in case of labeling and writing of batch number, etc, etc. The packaging material is used according to the nature and distribution of product.

DISTRIBUTION CONTROL:

The responsibilities of Quality Control Department are not finished even after the distribution of finished dosage form in the market. The samples of each batch are kept in record and these samples are selected during packaging and are in the same packs as they are marketed. These are kept for years in order to examine or test the material for any purpose or necessary demand.


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OBJECTIVES OF QUALITY CONTROLEstablishment of quality standard:Main motive of QC is the economical production of a high quality product at the quality level the customer wants.

Locating quality deviations:It is necessary to analyse the trend and extent of quality deviations in a manufacturing process, which should be explained by statistical techniques.

Evaluating methods and processes of production:It is a corrective measure to maintain the quality.

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Quick sale of quality goodsQC accelerates the sale of the goods by supplying only the quality goods.

Production of standard quality goodsQC aim at manufacturing standard quality products and avoids producing inferior quality goods.

Improvement in qualityAims at creating quality consciousness at all levels in the organisation.

OBJECTIVES OF QUALITY CONTROL

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STEPS IN QUALITY CONTROL

• 1. DEVISING THE CONTROL OVER RAW MATERIALS:

• The quality of the finished products is determined mostly by the quality of raw

materials.

• 2. FIXING STANDARDS AND SPECIFICATIONS:

• In order to make any scheme of quality control successful, it is necessary to

predetermine standards and specifications.

• 3. EXERCISING CONTROL OVER PRODUCTION OPERATIONS:

• In order to execute efficient practices, the technical expert of the Quality Control

Department must investigate the operating methods.

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• 4. LOCATING INSPECTION POINTS:

• When the points at which defects occur are wrongly located or located with delay, it

hinders quality control. Hence there should first be inspection of raw material at

vendors place, then at company’s plant then at various stages during process.

• 5. MAINTAINING QUALITY OF EQUIPMENTS:

• The final quality of the products is conditioned by the quality of the equipment and

other devices used.

• 6. MAINTAINING RECORDS:

• The QC department is responsible for setting records related to quality inspection

and control and the number rejected

STEPS IN QUALITY CONTROL

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ADVANTAGES OF QUALITY CONTROL

1) Improvement of the quality of production and reduction in the production cost.

2) Uniformity in the production and supply of standard quality goods to consumers.

3) Offering full return of the price paid by the consumers and giving convenience and satisfaction to consumers .

4) Reduction in spoiled production and rejection from consumers and dealers.

5) Promotion of exports due to superior and standard quality production.

6) Reduction in inspection cost.7) Making products popular in market.

COST OF QUALITY

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COST OF QUALITY• The costs of carrying out company quality program are known as Cost of

Quality. It includes –• Market research cost of discovering quality needs of customer. • Product research and development cost of creating a product concept,

which will meet quality needs. • The design cost of transmitting product concept into information which

represents planning for manufacturer.• Cost of inspection and test. • Cost of defect prevention. • Cost of quality assurance. • Cost of scrap and quality failure.

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COST OF QUALITY

COST OF PREVENTION

COST OF APPRAISAL

COST OF INTERNAL FAILURES

COST OF EXTERNAL FAILURES

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COST OF PREVENTIONIt consists of costs associated with person engaged in designing,

implementing, maintaining the quality system. Cost of prevention includes- • Cost of Quality planning• Cost of Documenting.• Process control cost. • Cost of training.• Cost associated with preventing recurring defects.• Cost of investigation, analysis of correction of causes of defects by

quality central department. • Cost of consciousness programs.

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COST OF APPRAISAL• The cost of evaluating, quality and of identifying and segregating non-

conforming part and assemblies is called as the cost of appraisal. This consists of–• Receiving or incoming tests and inspection.• Laboratory and acceptance test. • Inspection and test. • Checking labor.• Set up for inspection and test and test material.• Quality Audits.• Review of test and inspection data. • Evaluation of field stocks, spare parts.

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COST OF INTERNAL FAILUREThe costs associated with defective products, components, materials that

fail to meet quality requirements and results in manufacturing losses are called as cost of internal failures.

These include-• Costs associated with scrap, cost of material, labor. Cost of rework,

repair i.e. cost of making defective parts and assembly rules. • Cost of re-inspection and re-test after defective parts are repaired.• Costs associated with material review activity. • Cost of processes yield lower that might be attainable by improved

controls. • Trouble shooting.

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COST OF EXTERNAL FAILURE This is the cost because of defective products being shifted

to the customer. It includes-• Cost of processing complaints from the customer.• Cost of service to customer to receive defective items.• Cost of inspecting, preparing defective items.• Cost of replacing defective products.

TOTAL QUALITY MANAGEMENT• According to John Gilbert, Total Quality Management is "A process

designed to focus on customer expectations, preventing problems, building commitment to quality in the workforce and promoting open decision-making.“• It is a comprehensive concept. Not restricted to only goods and services.• High quality standards should be maintained in other aspects of

management such as production cost, marketing, sales promotion, etc. • To achieve this quality/efficiency- develop consciousness/awareness

among employees working in all departments of the enterprise. • Co-operation/involvement is necessary for maintaining efficiency in all

aspects of business management.

• In brief, quality management is not the responsibility of management alone. • Participation/involvement of both parties (management and

employees) is essential for achievement of quality and other benefits.

TOTAL QUALITY MANAGEMENT

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ELEMENTS OF TQM

FOCUS ON CUSTOMER

EXPECTATIONS

EMPLOYEE’S INVOLVEMENT

MASTERY OF THE

PROCESSES

TEAMWORK

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WHY IS IT NEEDED?• For consumer satisfaction and pleasure.

• TQM is needed as it suggests progressive philosophy in business, in which the stress will be on consumer expectations, total commitment to quality and participative management.

• To face market competition effectively, to create goodwill and to have support of consumers.

• For lowering rejection rate in production process and also for reducing the complaints of consumers.

• For motivation of employees and also for giving them better facilities, training and participation in decision-making.

• To facilitate industrial growth, economic progress and prosperity to the nation.

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PRINCIPLES OF TQMStress on quality management

Continuous process

Stress on quality assurance system

Linkage of quality and productivity

TQM is a gradual process

Focus on customers

Employee involvement

Formation of quality improvement teams

Management's involvement

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1. Stress on quality management: • Collective efforts are being made for improving quality of goods and services to

give more satisfaction to consumers. • Quality improvement is also useful for facing market competition and for

creating market reputation. • TQM involves steps for improving quality and productivity. • There is total commitment to quality on the part of entire Organisation.2. Continuous process: TQM is a continuous process/activity as there is ample scope for using new methods and techniques for improvement in the quality standards and performance. Implementation of innovative ideas or taking benefit of new opportunities is an integral aspect of TQM. TQM is a never ending quest for achieving new levels of performance.

PRINCIPLES OF TQM

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3. Stress on quality assurance system:• The aim of TQM is to give maximum satisfaction to consumers by providing goods

which are best in quality (zero defects). • The present ISO9000 series is a set of well recognised standards for quality

assurance system. • The Japanese have been using quality assurance concepts and principles as a part

of their TQM implementation programme even when specific name or number was not used. • Thus, quality assurance system is an integral part of TQM. 4. Linkage of quality and productivity:• The methods used in TQM programmes E.g. stress on quality improvement, zero

defects production, making all employees responsible for quality maintenance and improvement) are likely to bring quality improvement as well as yield improvement.• Similarly, the TQM programme creates a feeling of participation among the

employees. • There is also positive improvement in the morale of employees.

PRINCIPLES OF TQM

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5. TQM is a gradual process:• It includes self improvement and group improvement programme through team building

for raising quality and productivity. • TQM is about the gradual change of people's behavior towards the tasks they perform and

their attitude towards other people. • A mental revolution among the employees is required for the execution of TQM. • However, such change in the mental make-up of managers and employees requires long

period. This suggests that TQM is a gradual process. There are, in fact, four broad phases in the introduction of TQM. These are: (a) Awareness Phase, (b) Planning Phase, (c) Implementation Phase, and (d) Institutional Phase.

6. Focus on customers:• Customers are the source of all the revenue that flows through the corporation.• Their satisfaction keeps the money flowing especially in an open market where competitors

are pursuing them too. • The focus of TQM is on customer satisfaction on quality, cost and delivery through

improved orgarnisational quality of processes. • According to British Quality Association (BQA), TQM is a corporate business management

philosophy which recognised that customers' needs and business goals are inseparable.

PRINCIPLES OF TQM

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7. Employee involvement: • Their participation and co-operation are required to be taken at all levels. • TQM is possible only through participative management. • Under TQM, employees will be motivated to participate actively in the process of quality

improvement through incentives and recognition of contribution for achieving quality standards.

8. Formation of quality improvement teams: • A cornerstone of TQM is the team building that leads to commitment to improvement. • Such teams include quality steering teams, corrective actions teams and so on. Such

teams motivate employees and facilitate quality improvement.9. Management's involvement: • TQM is a systems approach in managing business and improving overall performance.• It needs total commitment from the top management to provide viable leadership to the

whole approach. • Top level management has to take number of initiatives in order to start the process of

TQM. In fact, TQM cannot have a good take off without total commitment of CEO and other senior executives.

PRINCIPLES OF TQM

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ADVANTAGES OF TQM

• Customer satisfaction• Quality improvement• Absence of additional investment• Raises competitiveness• Facilitates expansion and diversification• Provides trained and motivated employees• Miscellaneous Advantages• (a) Long-term consumer support,• (b) Prestigious position in international marketing,• (c) High standard of living to employees, and• (d) Cost control.

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QUALITY CIRCLE

It is defined as a way of capturing the creative and innovative power that lies within the work force.

A Quality Circle is a small group of volunteers doing similar work.They meet regularly under the leadership of their immediate supervisor

to- Identify problems. Set priorities. Discover causes. Propose solutions.

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The problems may concern- Quality. Productivity Safety Job structure Process flowThus Quality Circle is a participative management system in which

workers make suggestions and improvements for the betterment of organization.

QUALITY CIRCLE

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CONCEPT OF QUALITY CIRCLE

It consists of the following attributes:1. QC is a form of participative management.2. QC is a human resource development technique.3. QC is a problem solving technique.

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OBJECTIVES OF QUALITY CIRCLE

1. To improve quality and productivity.2. To reduce cost of products/services.3. To identify and solve problems.4. To tap intelligence of workers.5. To develop and motivate employees.6. To improve communication within organization.7. To increase employees loyalty and commitment.8. To respect humanity and make work place happy.9. To enrich human capability, confidence, moral, attitude and

relationships.10. To satisfy human needs

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ADVANTAGES OF QUALITY CIRCLE1. Promote productivity and quality mindedness.2. Development of employees.3. Creating team spirit and unity of action.4. Increased motivation, job satisfaction and pride in work.5. Reduced absenteeism and labor turnover.6. Developing sense of belongingness towards organization.7. Waste reduction.8. Cost reduction9. Improved communication.10. Safety improvement11. Increased human resource potential.12. Increased consciousness and moral of employees.13. Leadership development.14. Trained staff.

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Health & Medicine

Quality control measures in pharmaceutical industry