UNIT I INTRODUCTION TO QUALITY CONTROL The concept of total quality control refers to the process ef striving to produce a perfect product by a series of measures requiring an organized effort by the entire company to prevent or eliminate errors at every stage in production. Although the responsibility of assuring product quality belongs principally to quality assurance personnel, it involves many departments and disciplines within a company. “Quality control can be defined broadly as the day-to-day control of quality within a company, a department staffed with scientists and technicians responsible for the acceptance or rejection of incoming raw materials and packaging components, for the myriad of in-process tests and inspections, to assure that systems are being controlled and monitored and finally, for the approval or rejection of completed dosage forms. Quality control, therefore, includes not only the analytical testing of the finished product, but also the assessment of all operations beginning with the receipt of raw materials and continuing throughout the production and packaging operations, finished product testing, documentation, surveillance and distribution. 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. Quality control system is established at the conception of a new product, during production of the batch, and during distribution of the commercial package. This system is a combination of those administrative and technical procedures which must be used to produce and deliver a safe, pure, and effective product to the end user. Thus, quality control program department is organized to maintain the quality of products to a prescribed level. Quality control is a tool which gives the assurance that a product conforms to standards and specifications through a system of inspection, analysis and action. The potential benefits derived from a quality control system are as follows: 1, The system minimizes or eliminates the risk of marketing unsafe products. 2. It guarantees conformance to regulatory requirements. 3. Tt guarantees product efficacy. 4. It reduces operating costs.5. | It reduces operating losses. 6. It produces higher employee morale. 7. It motivates the pharmaceutical/medical professions to sell or prescribe the product. “Quality Assurance may be defined as the responsibility of an organization to determine that systems, facilities and written procedures both are adequate and followed in order to assure that products are controlled and will meet, in the final dosage form, all the applicable specifications. Organization of Quality Control ---\ | Quality Control Manager | 7 ~--| Materials Inspection Section | --/ aon] Analytical Laboratory 1 Specifications & Analytical Development nomena) \- t - aeennenn\, \---] quality Coordinating office | \ cen Seay A Quality Control Organizational Chart Materials Inspection Section Inspectors are alert individuals who had experience and who are familiar with the physical characteristics of the materials they sample and are well versed in sampling ‘techniques. The functions of this section are: 1. To sample and examine al] raw materials received.2. To sample and conduct physical tests on: a. All shipments of packaging materials b. All manufacturing, filling and packaging operations 3. To maintain periodic examination on the quality of inventories throughout all phases of storage, shipping and distribution. 4. To perform an audit which is independent of the work done by product personnel. Inspection stations are placed in the area of operation; viz., warehouse, manufacturing and packaging areas. _ Analytical Laboratory the Analytical Laboratory is responsible for testing and approving raw materials, work in-process and finished product. In order to perform physical, and chemical analysis, the analysts should know the usual gravimetric and volumetric analysis. Furthermore, they should be skillful in handling instruments for ultraviolet and infrared spectrophotometry, non- aqueous titrimetry, autoanalysis, polarography, x-ray diffraction, x-ray fluorescence, ‘spectrophotoflourinetry, radioactive tracer techniques and chromatography; viz.: column, gas, paper, thin-layer and high performance liquid chromatography. Tests and specifications may be found in several sources such as USP, NF, BP and Merck Index. Biological Testing Laboratory The staff in a biological testing laboratory should be well trained and experience in both simple and complex microbiological procedures and biological interactions. They should possess a high degree of skill and judgment in order to perform the job. A veterinarian is recommended to supervise the care and maintenance of the various species of animals used in -the tests. The functions of this laboratory are: 1. fo perform and evaluate microbiological and pharmacological assays, sterility, pyrogen and bacteriological tests, irritation, safety or acute toxicity tests. 2. To conduct environmental monitoring. Sterile conditions should be provided for areas where biological tests are conducted. Noise should be precluded from