SIM 1QC

• Quality


  Totality of characteristics or features of a product that bears on its capacity to satisfy stated or implied needs
• Quality Control


  Part of Good Manufacturing Practice (GMP) concerned with sampling, specifications, testing, organization, documentation and release procedures
• Quality Assurance


  Sum total of the organized arrangements made with the object of ensuring that products will be consistently of the quality required for their intended use
• ISO (International Organization for Standardization)


  This organization develops the standards, and it does in order to certify businesses or organizations
• Quality Control Chart


  A graphical representation of whether a firm's products or processes are meeting their intended specifications

  
• Accuracy


  Closeness of measurements to true value
• Precision


  A characteristic that refers to the agreement among repeated measurements
• Sampling plan


  The process of removing appropriate # of items from a population
• Defect


  An undesirable characteristics of a product and therefore its failure to conform to specifications
• Volumetric Analysis


  The determination of the volume of a solution of known concentration required to react with a given amount of the substance to be analyzed (ex. Titration)
• Titrimetric methods


  An analytical method in which the volume of a solution of known concentration consumed during an analysis is taken as a measure of the amount of active constituent in a sample analyzed
• Several definitions of quality
• The concept of total quality control refers to the process of 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
• Quality control 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
• Potential benefits of a quality control system

  • Minimizes or eliminates the risk of marketing unsafe products
  • Guarantees conformance to regulatory requirements
  • Guarantees product efficacy
  • Reduces operating costs
  • Reduces operating losses
  • Produces higher employee morale
  • Motivates the pharmaceutical/ medical professions to sell or prescribe the product
• In recent years, the Quality Assurance used to describe the overall organizational body designed to assure product quality, while Quality Control is limited to that function for on line or in process testing
• FDA has issued a primary regulation to the industry entitled current Good Manufacturing Practice (cGMP or GMP)- AO # 220 , s. 1974
• Functions and Responsibilities of Quality Assurance


  • Establishes systems for ensuring the quality of the product
  • Final authority for product acceptance/ release or rejection
  • Report to chief executive or president
  • Quality monitoring or audit functions (adequate systems, facilities and written procedures)
• Functions and Responsibilities of Quality Control


  • Responsible for the day to day control of quality w/in a company
  • Staffed w/ scientists and technicians, responsible for sampling and analytical testing for incoming raw materials and inspection of packaging components including labeling
  • Conduct in- process testing
  • Inspect operations for compliance
  • Conduct tests on finished dosage forms
  • Monitors product quality, testing product complaint samples, evaluating product quality
  • Perform environmental monitoring
• Class 100


  An area that can be controlled to contain fewer than 100 particles, 0.5 µm and larger per cubic foot of air
• ISO's name is derived from the Greek isos, meaning "equal"
• Standards make an enormous and positive contribution to most aspects of our lives
• What ISO standards do

  • Make the development, manufacturing and supply of products and services more efficient, safer and cleaner
  • Facilitate trade between countries
  • Provide governments with a technical base for health, safety and environmental legislation, and conformity assessment
  • Share technological advances and good management practice
  • Disseminate innovation
  • Safeguard consumers, and users in general, of products and services
• Organization of Quality Control

  • Materials Inspection Section
  • Analytical Laboratory
  • Biological Testing Laboratory
  • Specifications and Analytical development
  • Quality Coordinating Office
• Functions of Materials Inspection Section

  • To sample and examine all raw materials received
  • Conduct physical tests on all shipments of packaging materials and all manufacturing, filling and packaging operations
  • Maintain periodic examination on the quality of inventories throughout all phases of storage, shipping and distribution
  • Perform audit which is independent of the work done by product personnel
• Functions of Analytical Laboratory

  • For testing and approving raw materials, work in-process and finished product
  • To perform chemical and physical analysis / tests and specifications maybe found in several sources as USP, NF, BP and Merck Index
• Functions of Biological Testing Laboratory


  • To perform and evaluate microbiological and pharmacological assays, sterility, pyrogen and bacteriological tests, irritation, safety or acute toxicity tests
  • Conduct environmental monitoring
• Functions of Specifications and Analytical Development


  • Coordinate w/ research, product development, production, sales and management towards improvements of product
  • Establish specifications for raw and packaging materials
  • Validate existing and tentative procedures of testing
  • Establish specifications based on validation procedures
  • Develop new assay methods for in-house use
  • Develop and improve specifications for quality characteristics of the final product being manufactured
• Functions of Quality Coordination Office


  • Maintain and store records that represent the history of the batch from start to finish
  • To furnish data that will aid in analyzing product performance in the market
  • Investigate customer complaints
  • Maintain and develop SOP's
• Classification of Defects


  • According to measurability: Variable defect, Attribute defect
  • According to seriousness or gravity: Critical defect, Major defect, Minor defect
  • According to nature: Ocular defect, Internal defect, Performance defect
• Sources of Quality Variations

  • Materials: Variations between suppliers, Variations between batches, Variation within a batch
  • Machines: Variation of equipment for the same process, Difference in adjustment of equipment, Aging and improper care
  • Methods: Inexact and inadequate procedures, Negligence by chance
  • Men: Inadequate training and understanding, Improper working conditions, Dishonesty and fatigue
• Quality Functions


  • Analysis Functions
  • Monitor Functions
  • Record Review and Release Functions
  • Audit Function
• Characteristics of a successful analyst


  • Manipulative skill acquired by experience
  • Ability to follow directions under supervision of skilled analyst
  • Has fundamental knowledge of theory
  • Practical ability in the application of analytical methods
  • Skill of technique, patience, neatness and accuracy
  • Must not only use common sense in the laboratory but think throughout each step of the procedure
• At least 2 determinations of any analytical value are required (trials and replicates)
• Practices for economy of time


  • Keep the working area clean
  • Clean all apparatus immediately after using
  • Label all solutions
  • Keep 2 or more operations going at one time
  • Utilize all time between operations in making calculations and writing up experiments
• Grades of Chemicals


  • Reagent ACS
  • Guaranteed Reagent (GR)
  • Analytical Reagent (AR) / Reagent Grade
  • Primary Standard
  • Purified
  • Lab Grade
• Clean all apparatus immediately after using

  1. Clean

  2. Immediately after using
• Keep 2 or more operations going at one time


  1. Keep

  2. 2 or more operations

  3. Going at one time
• Utilize all time between operations in making calculations and writing up experiments


  1. Utilize

  2. All time between operations

  3. Making calculations

  4. Writing up experiments
• Reagents


  • Must be pure
  • Conform to USP/NF requirement
  • AR grade