2. QUALITY CONTROL
Quality control (QC) is a procedure (s) intended to
ensure that a manufactured product or performed
service adheres to a defined set of quality criteria or
meets the requirements of the client or customer.
It is a combination of all the characteristics of a product
that determine the degree of acceptability of the product.
QC is similar to, but not identical with, quality
assurance (QA).
3. QUALITY CONTROL VERSUS QUALITY
ASSURANCE
The terms often used interchangeably to refer to ways
of ensuring the quality of a service or product.
Quality Assurance: The planned and systematic
activities implemented in a quality system so that quality
requirements for a product or service will be fulfilled.
Quality Control: The observation techniques and
activities used to fulfill requirements for quality.
An evaluation to indicate needed corrective responses;
the act of guiding a process in which variability is
attributable to a constant system of chance causes.
4. QUALITY CONTROL VERSUS QUALITY
ASSURANCE
QA is a failure prevention system that
predicts almost everything about product
safety, quality standards and legality.
QA department develops all the
planning processes
QA defines the standards/methodology
to be followed in order to meet the
customer requirements.
QA activities are done before the
product is manufactured or the service
delivered (proactive approach).
QA is process oriented.
QA makes sure you are doing the right
things, the right way.
QC is a failure detection system that
uses a testing technique to identify
errors or flaws in products and tests the
end products at specified intervals.
Follows up on the QA’s action
QC ensures that the defined standards
are followed at every step.
QC activities are done during the
manufacturing process and once the
product is manufactured.
QC is product oriented.
QC makes sure the results of what
you've done are what you expected.
QA QC
5. INTRODUCTION TO GMP
Good manufacturing practice (GMP) is a system for
ensuring that products are consistently produced
and controlled according to quality standards.
It is designed to minimize the risks involved in any
pharmaceutical production that cannot be
eliminated through testing the final product.
BASIC FUNDAMENTALS INCLUDES
Control
Quality
Safety
Effectiveness,
6. GMP
GMP covers all aspects of production, including;
• Personnel
• Premises
• Equipment
• Starting materials
• Production & In-process control
• Laboratory Control
• Packaging & Labeling
• Holding & distribution (ware house)
Documentation:
• There must be systems to provide documented proof that correct
procedures are consistently followed at each step in the manufacturing
process - every time a product is made.:
7. Why is GMP important?
Avoids poor quality medicines, a health hazard
Saves waste of money for both government and individual
consumers.
Helps boost pharmaceutical export opportunities
Reduces and prevents errors
Prevents contamination & cross contamination
Minimizes variance in drug potency
Prevents toxicity
Prevents mislabeling
Avoids adulteration
8. ORGANIZATION AND PERSONNEL
Lay out of clean rooms
Wear clean clothing
Wear protective apparel to prevent contamination
Practice good sanitation
If sick or have open lesions that would impact the
drug, excluded from direct contact with the product
Regular medical check-ups
9. BUILDING AND FACILITIES
Building will be adequately sized for proper storage
of equipment and material
Operations will be performed in specific areas
Raw materials received will be placed in quarantine
until tested
Rejected material will be separated
Adequate lighting
Adequate environmental controls
Air breaks on drains
10. EQUIPMENTS
Maintained in a good state & qualified
(Design, Cleanliness, Installation, Performance)
Placed in appropriate place ( temperature &
humidity control)
Will be cleaned with approved cleaning
agents
will not affect product
written schedule of cleaning
clean after each batch
ID number on equipment
11. STARTING MATERIAL
Received in Quarantine
not used until released
Written procedures on receipt, handling and
sampling
Stored off the floor
Each container marked with lot number,
name and status (released, quarantined,
rejected)
12. PROCESS CONTROL
There will be written procedures
Document activities
batch record
log books
Work Instruction & operating procedures
Control contamination
Line clearance & Cleanliness &
tanks, paddles, piping, probes, etc.
Keep organized
13. WARE HOUSE
It shall be clean
Sections clearly identified:
quarantine - yellow
released - green
rejected - red
FIFO: First In - First Out
Track inventory and sold lots
14. PACKAGING AND LABELLING
The written display on the container
Document receiving
Separate labeling to avoid mix up
Set procedures for appropriate:
• Identity
• Storage
• Handling
• Sampling
• Testing
Inspection prior to issuance
Label control begins with design
15. QC LAB
Have specifications, standards, sampling
plans, test procedures
Shall have a calibration and maintenance
program
written with a time period for performance
Document all testing
use logbooks
Stability testing done
Reserve samples will be kept for final
products over the period of the expiration
date
16. DOCCUMENTATION
Records maintained
batch records
testing
investigations
training
maintenance
Cleaning
If it was not documented, then it did not
happen!
17. DUTIES OF H.O.D
Authorization of written procedures
Control & Monitoring
Process validation
Calibration of analytical apparatus
Plant hygiene
Training
Retention of records
Monitoring of compliance of GMP
Inspection and investigation to assure quality
18. DUTIES OF PRODUCTION INCHARGE
To ensure following:
Product produced, stored and documented as per
quality
Approve instruction for production operations &
strict implementation
Evaluation of production records and its availability
to QC
Check maintenance of department, premises and
equipments
Ensure process validation
Training
19. DUTIES OF QUALITY CONTROL
INCHARGE
To approve, reject the starting material, packaging
material, intermediate, bulk and finished good.
Evaluate batch record
Approve sampling instruction
Ensure necessary testing
Check maintenance of department, premises and
equipment
To ensure training of other QC personnel’s
20. OBJECTIVES & KPI’S
OBJECTIVES
100% compliance of Drug Rules and GMP
Make and execute each category of product
standard
New products every year
KPI’s
Product standards
GMP compliance
BMR, Batch records, Test reports
Minimal non-conformity
No. of Projects to improve Quality
