The 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 quality Definition No. 2 Freedom from deficiencies Definition No. 1 Meeting customer needs Reduces error rates Reduces rework, waste Reduces customer dissatisfaction Reduces inspection, test Increases yield, capacity Improves delivery, performance Increases customer satisfaction Makes product salable Helps meet competition Increases market share Provides sales income Major effect is on the cost Major effect is on the sales Higher quality costs less Higher quality costs more

Quality The 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 quality Desired characteristics of product to ensure:  Efficacy  Safety  Quality or Acceptability  Stability

Fitness 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 and produce dosage forms that contain the exact quantities of drugs and the acceptable, reproducible, convenient and elegant properties.  The quality, purity, potency, uniformity, stability and safety as well as physiological availability and therapeutic activity are important characteristics of the dosage form.  To assure and control these characteristics there must be a continuous research for the causes of defects and their subsequent prevention. Defects are determined during the entire production operation from the raw materials to the finished product.  To provide for quality assurance, appropriate process control must be carried out at each phase of the production and packaging operations to eliminate errors of manufacturing and to prevent an end product of subquality.

Pharmaceutical Product Quality Cannot 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 principally to quality assurance personnel, it involves many departments and disciplines within a company. ● Quality must be built into a drug product during product and process design, and it is influenced by the physical plant design, space, ventilation, cleanliness, and sanitation during routine production. ● The product and process design begins in research and development, and includes pre-formulation and physical, chemical, therapeutic, and toxicological considerations.

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 control Is designed to detect, reduce and correct deficiencies in a laboratory’s internal analytical process prior to the release of patient results and improve the quality of the results reported by the laboratory. Quality control Is a measure of the precision or how well the measurement system reproduces the same result over time and under varying operating conditions.

Determinants of Medicine Quality Identity: Active ingredient. Purity: Not contaminated with potentially harmful substances. Potency: Usually 90–110% of the labeled amount. Uniformity: Consistency of color, shape, size. Other Specifications: polymorph, particle size, dissolution. Bioavailability: Drug absorption. Stability: 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 individual product specifications. ● These specifications ensure that the product fulfills the basic requirements of identity, purity, strength, and bioavailability. 1. Identity: The product must comply with the information given on the product label. 2. Strength or potency: The product contains the quantity of each ingredient claimed on its label, within the applicable limits of the specification. This may be determined by chemical testing (strength) or by reference to a biological standard (potency).

3. Purity: This is defined as the extent to which a raw material or a drug in dosage form is free from undesirable or adulterating chemical, biological, or physical entities as defined by the specification. 4. Bioavailability/biopharmaceutical properties:  Upon administration, the product must provide the active ingredient for the intended therapeutic/biological availability.  Bioavailability is the rate and extent of absorption of a drug from a dosage form as determined by its concentration/time curve in the systemic 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 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.

3. Methods  Inexact procedures  Inadequate procedures 4. Men  Improper working conditions.  Inadequate training and understanding.  Lack of interest.  Dishonesty, fatigue and carlessness.

The 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 departments and under the authority of a person with appropriate qualifications and experience. ●Adequate resources must be available to ensure that all the quality control arrangements are effectively and reliably carried out. ● Quality control department as a whole will also have another duties, such as to establish, validate and implement all QC procedures. ● Keep the reference samples of materials and products, ensure the correct labeling of containers of materials and products, participate in the investigations of complaints related to the quality of the product, etc. ● All these operations should be carried out in accordance with written procedures and recorded.

 The assessment of finished products should embrace all relevant factors, including production conditions, results of in-process testing, a review of manufacturing (including packing) documentation, compliance with the finished product specifications, and examination of the final finished pack.  It is essential that QC personal should be granted access to production areas for sampling and investigation as appropriate.