QC & QA (MM Copy)

• Quality is a combination of attributes that serve as a basis for measuring the uniformity of a product and determines its degree of acceptability
• Quality of a drug product is defined as the sum of all factors contributing directly or indirectly to its safety, effectiveness, and reliability
• Market-oriented definition of quality includes 3 major elements:

  • Functional element: the product meets consumer's specifications in point of use (safe & effective for therapeutic action)
  • Aesthetic element: the product possesses an attractive design
  • Technological properties: the product can withstand surrounding conditions
• Measurable quality definitions:

  • Conformance: the product should be within its prescribed limits or specifications
  • Fitness for use: considers the design or purpose for which the product is made
  • Reliability: the probability that the product will perform its intended function in the specified environment for a prescribed length of time
  • Yield: minimal or no defects resulting in a high degree of acceptable units produced
  • Customer satisfaction: achieving customer acceptance by being safe, pure, and effective
• Quality Control (QC) ensures that a product conforms to standards and specifications through inspection, analysis, and action
• Quality Assurance (QA) provides evidence to establish confidence that quality-related activities are being performed adequately
• Management objectives:

  • PLOC: planning, leading, organizing, and controlling
  • Financial plan involves monetary expenditures and profits
  • Strategy is a broad program for defining and achieving organizational objectives
  • Strategic Plan is designed to meet broad organizational goals
  • Operational Plan provides details for incorporating organizational strategy into day-to-day operations
• Mission of a quality management department:

  • Total commitment to ensure products meet prescribed standards for quality, safety, and effectiveness
  • Vision to be recognized for expertise in sustaining high product quality
• Quality Organization/Responsibilities:

  • Quality Manager reports to a high-level administrator
  • Quality Control responsible for day-to-day quality control within the company
• Quality Control (Manager; Pharmacist) functions:

  • Specification & Assay Development Section
  • Central Release Section
  • Chemical Control Section
  • Inspection & Checking Section
  • Biological - Microbiological Control Sections
• Potential benefits derived from a quality control system:

  • Minimum risk of marketing unsafe products
  • Conformance to regulatory requirements
  • Guaranteed product efficacy
  • Less operating costs and losses
  • Higher employee morale
  • Motivation for pharmaceutical and medical professionals
• Drug Standards:

  • Evaluated by pharmacopeial, in-house, or regulatory requirements
  • Pharmacopeial standards consist of specifications and procedures for substances and finished products
  • In-house standards are generated internally for control purposes
  • Regulatory standards mandated by regulatory agencies for compliance
• Standards and Specifications:

  • Quality characteristics interpreted by descriptive words and measurements
  • Standards and specifications developed to accept or reject a product based on formula, raw material specification, standard operating procedure, finished product specification, and packaging material/components
• Validation ensures production processes are controlled to perform as purported

  • Quality Assurance monitors and audits compliance to standards within the quality system
  • Responsible for advising senior management, implementing quality policies, liaison with regulatory agencies, product acceptance or rejection, preparing standard operating procedures, quality monitoring, and audit of all operations
• Packaging Material/Components should be set for everything that goes around the product, such as bottles, cans, aluminum foil, cellophane, jars, caps, cap liners, labels, package inserts, cartoons, wrapping paper, and shipping cases
• Test Methods are standardized or validated procedures that yield results of comparable precision, accuracy, specificity, and linearity
• Compliance to pharmaceutical good manufacturing practices (GMP) may not be enough for the organic growth of an organization
• Some firms find it advantageous to be accredited to an international consortium of representative bodies to develop uniform or harmonized international standards
• The International Organization for Standardization (ISO) in Geneva, Switzerland has developed industrial standards for worldwide trading or participation in the global economy
• ISO seeks to have an international language of quality through standards like ISO 9000 to 9004 to equalize quality systems between companies and countries
• ISO 9000 focuses on how the management system assures the quality of parts and services a company produces
• ISO 9001 is for companies engaged in manufacturing or in the development and delivery of a service
• ISO 9002 is for companies that perform all functions except the design and development of products and services
• ISO 9003 is for non-manufacturing companies such as distributors or warehousing operations
• ISO 9004 provides guidelines to help interpret ISO 9001, ISO 9002, and ISO 9003
• ISO certification certifies a management system, not the quality of goods produced
• Certification is achieved through a third-party assessment accredited by ISO-Geneva
• The local accredited assessor for certification in the Philippines is Certification International Philippines
• The Food and Drug Administration issued minimum requirements for a quality control facility of drug manufacturers as an addendum to Administrative Order No. 56 s. 1989
• US FDA Laboratory Practice Regulations prescribe good laboratory practices for conducting non-clinical laboratory studies supporting applications for research or marketing permits for FDA-regulated products
• Non-clinical laboratory studies include in vivo or in vitro experiments to determine the safety of test articles
• Non-clinical studies do not include studies utilizing human subjects or clinical studies or field trials in animals
• Defects are undesirable characteristics of a product, while defective refers to a unit of a product containing one or more defects
• Classification of defects can be based on measurability, seriousness, or nature
• Sources of variation in product quality can be materials, machines, methods, and men.
• To assure safety and therapeutic efficacy of drugs, internal factors like Total Quality Control and external factors like Current Good Manufacturing Practices are essential
• CGMP regulations apply to organization and personnel, buildings and facilities, equipment, components and drug product containers and closures, and production and process control
• A quality audit program should be established to monitor and evaluate the quality control laboratory effectively
• Documentation in a quality control laboratory is critical and includes a wide range of administrative and operational information
• Singer and Upton (1993) list types of information routinely recorded in a quality control laboratory