The concept of QualityThe concept of Quality

●Quality means those features of products which meet customers needs and thereby provide customer satisfaction. This meaning is oriented to income. Providing more and/or better quality features usually requires investment and hence usually involves increases in costs.

●Quality means freedom from deficiencies. Freedom from errors that require doing work over again. The meaning is oriented to costs.

The meaning of qualityThe meaning of qualityDefinition No. 1Definition No. 1

Meeting customer needsMeeting customer needs

Definition No. 2Definition No. 2

Freedom from deficienciesFreedom from deficiencies

Increases customer satisfactionIncreases customer satisfaction

Makes product salableMakes product salable

Helps meet competitionHelps meet competition

Increases market shareIncreases market share

Provides sales incomeProvides sales income

Reduces error ratesReduces error rates

Reduces rework, wasteReduces rework, waste

Reduces customer dissatisfactionReduces customer dissatisfaction

Reduces inspection, testReduces inspection, test

Increases yield, capacityIncreases yield, capacity

Improves delivery, performanceImproves delivery, performance

Major effect is on the salesMajor effect is on the salesMajor effect is on the costMajor effect is on the cost

Higher quality costs moreHigher quality costs moreHigher quality costs lessHigher quality costs less

QualityQualityThe quality in the pharmaceutical industry represents both function and process (many things to many people)

Function :There are operational groups whose major responsibilities are to assure quality creation and maintenance "The quality assurance

department "To monitor the specifications established to control activities

" The quality control department "

Process: Refers to that set of activities and operations which determine

whether a pharmaceutical product has quality.

The meaning of the pharmaceutical The meaning of the pharmaceutical qualityquality

Desired characteristics of product to ensure:

Efficacy Safety Quality or Acceptability Stability

Fitness of purposeFitness of purpose

●It is the right product

●It is the right strength

●It is free from contamination

●It has no way deteriorated or broken down

●It is the right container

●It is correctly labeled

●It is sealed in its container and protected against damage and contamination

It is the responsibility of pharmaceutical companies to design, test It is the responsibility of pharmaceutical companies to design, test and produce dosage forms that contain the exact quantities of drugs and and produce dosage forms that contain the exact quantities of drugs and the acceptable, reproducible, convenient and elegant properties.the acceptable, reproducible, convenient and elegant properties.

The quality, purity, potency, uniformity, stability and safety as well as The quality, purity, potency, uniformity, stability and safety as well as physiological availability and therapeutic activity are important physiological availability and therapeutic activity are important characteristics of the dosage form.characteristics of the dosage form.

To assure and control these characteristics there must be a continuous To assure and control these characteristics there must be a continuous research for the causes of defects and their subsequent prevention. research for the causes of defects and their subsequent prevention. Defects are determined during the entire production operation from the Defects are determined during the entire production operation from the raw materials to the finished product.raw materials to the finished product.

To provide for quality assurance, appropriate process control must be To provide for quality assurance, appropriate process control must be carried out at each phase of the production and packaging operations to carried out at each phase of the production and packaging operations to eliminate errors of manufacturing and to prevent an end product of eliminate errors of manufacturing and to prevent an end product of subqualitysubquality..

Pharmaceutical Product Quality Pharmaceutical Product Quality Cannot Be Tested in - It Is Built inCannot Be Tested in - It Is Built in

Pharmaceutical product quality is assured by -comprehensive development program

-extensive manufacturing and environmental controls -rigorous validation procedures and requirements

The high quality thus built into the final product is ensured through in-process controls and verified in a series of confirmatory tests before each manufactured batch is

released to the market

● ●Although the responsibility for assuring product quality belongs Although the responsibility for assuring product quality belongs principally to quality assurance personnel, it involves many principally to quality assurance personnel, it involves many departments and disciplines within a companydepartments and disciplines within a company..

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

● ●The product and process design begins in research and development, The product and process design begins in research and development, and includes pre-formulation and physical, chemical, therapeutic, and and includes pre-formulation and physical, chemical, therapeutic, and toxicological considerationstoxicological considerations..

Quality control (QC)Quality control (QC)

Testing samples to check compliance with a predetermined specification .

It is concerned with sampling, specifications, and testing as well as the organization, documentation and release procedures which ensure that the necessary and relevant tests are carried out.

Ensure that materials are not released for use, nor products released for sale or supply, until their quality has been judged as satisfactory.

Quality controlQuality controlIs designed to detect, reduce and correct deficiencies in a Is designed to detect, reduce and correct deficiencies in a laboratory’s internal analytical process prior to the release of laboratory’s internal analytical process prior to the release of patient results and improve the quality of the results reported by patient results and improve the quality of the results reported by the laboratory.the laboratory.

Quality controlQuality controlIs a measure of the precision or how well the measurement Is a measure of the precision or how well the measurement system reproduces the same result over time and under varying system reproduces the same result over time and under varying operating conditionsoperating conditions..

Determinants of Medicine QualityDeterminants of Medicine QualityIdentity:Identity: Active ingredient Active ingredient..

Purity:Purity: Not contaminated with potentially harmful substances Not contaminated with potentially harmful substances..

Potency:Potency: Usually 90–110% of the labeled amount Usually 90–110% of the labeled amount..

Uniformity:Uniformity: Consistency of color, shape, size Consistency of color, shape, size..

Other Specifications:Other Specifications: polymorph, particle size, dissolution polymorph, particle size, dissolution..

Bioavailability:Bioavailability: Drug absorption Drug absorption . .

Stability:Stability: Ensuring medicine activity for stated period Ensuring medicine activity for stated period..

Identity, purity, potency, uniformity are defined in pharmacopoeias and stated in certificate of analysis (COA)

● ●The pharmaceutical product quality parameters are laid down in The pharmaceutical product quality parameters are laid down in individual product specifications.individual product specifications.

● These specifications ensure that the product fulfills the basic ● These specifications ensure that the product fulfills the basic requirements of identity, purity, strength, and bioavailability.requirements of identity, purity, strength, and bioavailability.

1. Identity:1. Identity:

The product must comply with the information given on the product The product must comply with the information given on the product label.label.

2. Strength or potency:2. Strength or potency:

The product contains the quantity of each ingredient claimed on its label, The product contains the quantity of each ingredient claimed on its label, within the applicable limits of the specification. This may be determined within the applicable limits of the specification. This may be determined by chemical testing (strength) or by reference to a biological standard by chemical testing (strength) or by reference to a biological standard (potency)(potency) . .

33 . .Purity:Purity:

This is defined as the extent to which a raw material or a drug in This is defined as the extent to which a raw material or a drug in dosage form is free from undesirable or adulterating chemical, dosage form is free from undesirable or adulterating chemical, biological, or physical entities as defined by the specification.biological, or physical entities as defined by the specification.

4. Bioavailability/biopharmaceutical properties:4. Bioavailability/biopharmaceutical properties:

Upon administration, the product must provide the active ingredient Upon administration, the product must provide the active ingredient for the intended therapeutic/biological availability.for the intended therapeutic/biological availability.

Bioavailability is the rate and extent of absorption of a drug from a Bioavailability is the rate and extent of absorption of a drug from a dosage form as determined by its concentration/time curve in the dosage form as determined by its concentration/time curve in the systemic circulation, or by its excretion in urinesystemic circulation, or by its excretion in urine . .

Types of Quality Problems

•mislabeled drugs

•inaccurate or unreadable product labels/labeling

•sterile containers or vials that are punctured or leaking

•packaging or product mix-ups

•abnormal odor or taste

•capsule leakage

•chipped, cracked, or splitting tablets

• tablet or capsule discolorations

• broken, cracked, or chipped syringes

• suspected product contamination

• vials with foreign floating objects or growth

• container closure defects leaking vials

Types of Quality Problems (Cont.)

Sources of quality variationsSources of quality variations

The general sources causing product quality variation during manufacturing can be summarized as follows:

1 .Materials

Variation between suppliers of the same substances.

Variation between batches from the same suppliers.

Variation within a batch.

2 .Machines

Variation of equipment for the same process.

Difference in adjustment of the equipment.

Aging and improper care.

33 . .MethodsMethods Inexact procedures Inexact procedures Inadequate procedures Inadequate procedures

4. Men4. Men Improper working conditions. Improper working conditions. Inadequate training and understanding. Inadequate training and understanding. Lack of interest. Lack of interest. Dishonesty, fatigue and carlessness Dishonesty, fatigue and carlessness..

The quality control organizationThe quality control organization

There are 3 stages of operation in the control of quality:

Raw Ingredients

Process of manufacture

Inspection of the finished product

The prime responsibilities of quality control depts. are the approval of raw materials for use in production and the inspection of the finished

product .

● ●The quality control department should be independent from other The quality control department should be independent from other departments and under the authority of a person with appropriate departments and under the authority of a person with appropriate qualifications and experience.qualifications and experience.

●Adequate resources must be available to ensure that all the quality ●Adequate resources must be available to ensure that all the quality control arrangements are effectively and reliably carried out.control arrangements are effectively and reliably carried out.

● Quality control department as a whole will also have another duties, ● Quality control department as a whole will also have another duties, such as to establish, validate and implement all QC procedures.such as to establish, validate and implement all QC procedures.

● Keep the reference samples of materials and products, ensure the ● Keep the reference samples of materials and products, ensure the correct labeling of containers of materials and products, participate in the correct labeling of containers of materials and products, participate in the investigations of complaints related to the quality of the product, etc. investigations of complaints related to the quality of the product, etc.

● All these operations should be carried out in accordance with written ● All these operations should be carried out in accordance with written procedures and recordedprocedures and recorded..

The assessment of finished products should embrace all relevant The assessment of finished products should embrace all relevant factors, including production conditions, results of in-process testing, a factors, including production conditions, results of in-process testing, a review of manufacturing (including packing) documentation, compliance review of manufacturing (including packing) documentation, compliance with the finished product specifications, and examination of the final with the finished product specifications, and examination of the final finished pack.finished pack.

It is essential that QC personal should be granted access to production It is essential that QC personal should be granted access to production areas for sampling and investigation as appropriateareas for sampling and investigation as appropriate..