PRELIM: 2 Flashcards
is essential in the pharmaceutical industry to ensure drugs are safe, effective, and consistent.
Quality control
Quality is fitness for purpose or use. It refers to features and characteristics that satisfy consumer needs.
Juran’s Definition
Systematic control of variables in manufacturing that affect end product excellence.
Broom’s Definition
Techniques to manufacture products of uniform acceptable quality.
Alford and Beatty’s Definition
Reactive process focused on identifying defects in finished products before release. Aims to find and correct defects after development but before release.
Quality Control
Proactive process focused on preventing defects by improving development processes. Aims to improve processes so defects don’t arise during product development.
Quality Assurance
Role of Quality Control in
Pharmaceuticals
Ensure Safety and Efficacy
Keep Pace with Advances
Key Responsibilities
Drugs must be safe and therapeutically active with consistent, predictable performance.
Ensure Safety and Efficacy
Evaluate new medicinal agents using sophisticated analytical methods.
Keep Pace with Advances
Efficacy, safety, quality, and compliance.
Key Responsibilities
Quality Control Areas in Pharmaceuticals
Raw Materials and API
Packaging Components
Finished Products
Techniques: Raman/IR spectroscopy, HPLC
assay, physical tests
Raw Materials and API
Tests: Appearance, spectroscopy, loss on
drying
Packaging Components
Techniques: HPLC, assay, dissolution,
content uniformity
Finished Products
Control Measures (4)
Material control
Manufacturing practice control
Packaging control
Distribution control
Errors can occur at any stage from raw material reception to final packaging. Risk increases with more materials and complex methods
Quality Variation
Material Control
Reception and Testing
Documentation
Storage and Labeling
Maintain complete records of all procedures and tests
Documentation
Establish systems for receiving, testing, and
storing all supplies including drug substances, excipients, and packaging materials.
Reception and Testing
Properly store and label materials, conduct laboratory testing, and mark as “Passed” or “Rejected”.
Storage and Labeling
Manufacturing Practices Control (3)
Personnel
Equipment and Building
Record Control
Properly educated and trained staff in all departments. Regular training and supervision.
Personnel
Suitable design, size, construction, and location. Non-reactive, easy to clean and operate.
Equipment and Building
Maintain master formula records and batch production records for each product and batch.
Record Control
Use recommended containers, ensure correct labeling and batch numbers. Select packaging material based on product nature and distribution.
Packaging Control
Keep samples of each batch in record for years. Examine or test material for any necessary demand or purpose.
Distribution Control
Objectives of Quality Control (3)
Establish Quality Standards
Locate Quality Deviations
Evaluate Production Methods
Economical production of high-quality products at customer-desired levels.
Establish Quality Standards
Analyze trends and extent of quality deviations using statistical techniques.
Locate Quality Deviations
Implement corrective measures to maintain quality.
Evaluate Production Methods
Accelerate sales by supplying only quality goods.
Quick Sale of Quality Goods
Manufacture standard quality products and avoid inferior quality.
Produce Standard Quality Goods
Create quality consciousness at all organizational levels.
Improve Quality
Steps in Quality Control
Control Raw Materials
Set Standards and Specifications
Control Production Operations
Locate Inspection Points
Maintain Equipment Quality
Maintain Records
Ensure quality of raw materials as they largely determine finished product quality.
Control Raw Materials
Predetermine standards and specifications for successful quality control.
Set Standards and Specifications
Investigate operating methods to execute efficient practices.
Control Production Operations
Investigate operating methods to execute efficient practices.
Locate Inspection Points
Ensure quality of equipment and devices used as they affect final product quality
Maintain Equipment Quality
Keep records related to quality inspection, control, and rejections
Maintain Records
Quality planning, training, process control
Prevention Costs
Inspection, testing, quality audits
Appraisal Costs
Scrap, rework, re-inspection
Internal Failure Costs
Complaints, returns, warranty claims
External Failure Costs
A process designed to focus on customer expectations, prevent problems, build
commitment to quality, and promote open decision making
Total Quality Management (TQM)
Principles of TQM
Customer Focus
Employee Involvement
Continuous Improvement
Management Commitment
A small group of volunteers doing similar work, meeting regularly to identify problems, set priorities, discover causes, and propose solutions.
Focus Areas:
Quality, productivity, safety,
job structure, and process
flow
Quality Circle
Recognize that customer needs and business goals are inseparable.
Customer Focus
Encourage participation and cooperation at all levels.
Employee Involvement
Never-ending quest for achieving new levels of performance.
Continuous Improvement
Requires total commitment from top management for viable leadership
Management Commitment
