qc ii lecture notes 6/15/15
TRANSCRIPT
OBJECTIVES
• Understand the fundamentals of the quality control analysis in the pharmaceutical industry.
• Explain the different functions of quality control division.
• Explain the importance of quality control in pharmaceutical manufacturing firms.
• Review scope of CGMP
Walter Shewhart
• Father of statistical quality Contol
• The originator of Quality Control via control charts.
• He described Quality as having both objective and subjective.
OBJECTIVE
• Measurement of specifications within a minimum validation from target values.
Ex. Weight of the dosage formSize shape of the dosage formMoisture content
QUALITY
• Fitness for use
• Conformance to
Requirements
• Usefulness at a reasonable cost
• Freedom from deficiencies
QUALITY CONTROL
• Assessment of all operations beginning with the receipt of the raw materials to production, packaging, finished product testing, documentation , surveillance and destruction.
Benefits of QC
7. Motivate pharmaceutical/ med profession to sell/ prescribe the product
Benefits of QC
Stability testing
• Provides evidence on how the drug substance or product quality varies with time under environmental conditions during distribution.
• Helps to recommend storage conditions including establishment of shelf life, expiry date or retest period.
• Key assurance of quality of pharmaceuticals.
QUALITY ASSURANCE
• Systems, facilities and written procedures that should be practice according to standard that conforms to specifications.
QA versus QC
• Prevent defects on the process
• To improve development and test
• Identify defects in the finished product.
• Identify defects after the product in development and before its release.
ORGANIZATIONAL CHART OF QC DEPARTMENT
QC MANAGER
ANALYTICAL CONTROL
INSPECTION CONTORL ON RAW MATERIALS
BIOLOGICAL TESTING LAB
SPECIFICATION AND ANALYTICAL DEVELOPMENT
QUALITY COORDINATING OFFICEOr CONTROL RELEASE OFFICER
TOTAL QUALTIY CONTROL
• Organized effort within an entire establishment to design, produce, maintain and assure the specified quality in each unit of product distributed.
TOTAL QUALITY MANAGEMENT
• TOTAL= involves everyone and all activities in the company.
• QUALITY= conformance to requirements
(meeting customer requirements)
• MANAGEMENT= quality must and can be managed
TOTAL QUALITY MANAGEMENT
• A process for managing quality
• It must be a continuous way of life; a philosophy of perpetual improvement in everything.
B. ORGANIZATION and PERSONNEL1. Responsibilities of QC unit
- Assignment for TQC to assure product quality
2. Personnel Qualifications
- Training/ experience supervisory to operational
B. ORGANIZATION and PERSONNEL3. Personnel responsibilities
- Hygiene, clothing, medical status
4. Consultants
- Approved by QC
(qualifications)
D. EQUIPMENT
1. Design, size and location
2. Construction
3. Cleaning maintenance
4. Automatic/ mechanical/ electrical equipment
5. Filters
E. CONTROL FOR DRUG PRODUCT CONTAINERS and CLOSURES• Written procedures must be available 1. Receipt of untested components, storage
containers and closures.2. Testing and approval or rejection3. Use4. Retesting5. Rejection6. Drug product container
F. PRODUCTION and PROCESS CONTROL1. Written procedures
-SOPS
Any changes in the SOP should be:
- Investigated
- Recorded
- Approved prior to final product acceptance
Benefits of SOP
• Provide continual development of operations
• Improve of communication with employees
• Simplify new employee training
• Share experience knowledge and ideas
Typical structure of SOP
• Title page
• Company logo
• Header and title of SOP
• Department name
• Effective date
• Revision date
• Review date
Typical structure of SOP
• Page no
• Regulatory basis
• Reference documents
• Purpose
• Scope
• Responsibilities and accountabilities
• Procedures
Typical structure of SOP
• FooterApproving signatures-Prepared by-Checked by-Approved by
• StampControlled copy/ master copyQA stamp
F. PRODUCTION and PROCESS CONTROL2. Change in components-Calculation of Yield-Equipment identification-Sampling and Testing in-process materials
and drug product-Time limitation on production-Control of microbial contamination-Reprocessing
G. PACKAGING and LABELLING CONTROL1. Materials examination and usage criteria
2. Labelling Criteria
3. Packaging and Labelling operations
4. Drug product inspection
5. Expiration dating
J. RECORDS and REPORTS
1. Equipment cleaning and use
2. Component, drug container, closure, labelling records
3. Waste production and control records
J. RECORDS and REPORTS
4. Production record review
5. Laboratory records
6. Distribution record
7. Compliant file
K. RETURNED and SALVAGED DRUG PRODUCT1. Returned Drug Products
- Records, reason for return used as part of the total lot accountability
- Tracing of its distribution/ recall