Quality Control

Prepared by: Stephanie Lois R. Sanchez, RPh,

MSPh
Quality control
● What is Quality?
○ Combination of attributes or characteristics of a
product which, when compared to a standard, serves
as a basis for measuring the uniformity of the product
and determines its degree of acceptability.
● What is Quality Control?
○ A tool which gives the assurance that a product
conforms to standards and specifications through a
system of inspection analysis, and action.
Quality control
● CGMP
● ICH
● WHO
● PIC/s
● ASEAN
● ISO
Quality Control System
● Benefits:
a. Minimizes or eliminates the risk of marketing
unsafe products
b. Guarantees conformance to regulatory
requirements
c. Guarantees product efficacy
d. Reduces operating costs
e. Reduces operating losses
f. Produces higher employee morale
g. Motivates the pharmaceutical/medical professions
to sell or prescribe the product
Organization of Quality Control
● 1. Materials Inspection Section
○ Sample and examine all raw materials received
○ Sample and conduct physical tests.
○ Maintain periodic examination on the quality of
inventories throughout all phases of storage,
shipping, and distribution.
○ Perform an audit which is independent of the
work done by production personnel
Organization of Quality Control
● 2. Analytical Laboratory
○ Perform physical and chemical analysis
● 3. Biological Testing Laboratory
○ Perform and evaluate microbiological and
pharmacological assays. Sterility, pyrogen and
bacteriological tests, irritation, safety or acute toxicity
tests.
○ Conduct environment monitoring
Organization of Quality Control
● 4. Specifications and Analytical
Development
○ Coordinate with research, product development,
production sales and management
○ Establish specifications for raw and packaging
materials
○ Validate existing and tentative procedures of testing
○ Establish specifications based on validated procedures
○ Develop new assay methods for in-house use
○ Develop and improve specifications for quality
characteristics of the final product being manufactured
Organization of Quality Control
● 5. Quality Coordination Office
○ Maintain and store records
○ Furnish data that will aid in analyzing product
performance in the market
○ Investigate customer complaints or inquiries on
product quality
○ Call the attention of the appropriate development
group any aspect that provides a basis for
improvement of a product for consideration and action.
○ Provide data that give scientific and legal status
○ Maintain and develop SOP’s.
Quality Control Functions

● Analysis function
○ Assure the acceptability of a product
● Monitor Function
○ Sample and examine materials while they are being
processed
○ Environmental monitoring
Control Functions

● Record Review and Release Function

○ Reviewing the batch record and assuring that all
necessary records are present, complete and where
feasible to determine, accurate.
● Audit Function
○ To check and detect areas where the established
SOP’s are not being followed and report these findings
to the supervisor for appropriate action
Standards and Specifications
● Quality characteristics = quality variation

● Basis for Standards and Specifications:

○ Formula
○ Raw material specifications
○ Standard operating procedure
○ Finished product specification
 Standards and Specifications
● Basis for Standards and Specifications:
○ Packaging material standards
■ Consideration:
● May run on high-speed line
● Involved complicated assembly
● Must be functional
● Completely compatible with the product
● Protect the product and assure its stability
● Can withstand shipping
○ Testing methods
Errors
● Assignable causes;
○ Materials
○ Machines
○ Methods
○ Men
Defects
● Defective

● Types
● 1. According to measurability
○ Variable defect and Attribute defect
● 2. According to seriousness or gravity
○ Critical defect, Major defect, and Minor defect
● 3. According to nature
○ Ocular defect, internal defect, performance defect
 ICH: Stability

Prepared by: Stephanie Lois R. Sanchez, RPh,

MSPh
Stability
● Long term stability testing
● Intermediate stability testing
● Accelerated stability testing:
○ Temperature
○ Light
○ Moisture
○ Gravity
○ Agitation
○ Inversion
○ Method of manufacture
Stability
Physical and Chemical Stability
● Physical Stability;
○ Appearance
○ Uniformity
○ Availability
● Chemical causes of product
deterioration;
○ Incompatibility oxidation, reduction,
hydrolysis, racemization, decarboxylation,
deterioration of hydrogen peroxide and
formation of precipitates.
Stability Overages

● The voluntary introduction of a specific excess

during the manufacture of pharmaceutical forms of
medicaments that are unstable by nature and
difficult to stabilize, in order to maintain during their
period of use an active content within the limit's
compatible with therapeutic requirements.
Overages
● Justifiable:
○ The labile (unstable) active ingredients cannot
possibly be standardized.
○ The overage allows an even equilibrium of the
content of the active ingredient within acceptable
limits.
○ The overage would not present a possibility of a
therapeutic overdosage if the preparation were use
during the early part of the product’s shelf life.
○ The clinical studies show that overage is safe
therapeutically.
○ The lower limit proposed for the decrease in strength
applies only at the end of the period of validity of
unstable preparations.
Overages
● Rules on overages for vitamins
○ A loss of not more than 10% of the labeled potency
is considered normal at the end of the term of
validity of the product.
○ Different galenical dosage forms is considered
separately with a distinction made between simple
and complex preparations, including a separate
study of preparations containing higher doses.
○ The added overage is limited to no more than 30%
of the label's potency of the particular ingredient.
Overages
● Overage limit for diff. prep:
○ 15% dry dosage form
○ 20% ointment
○ 25% ointments, suppositories, aerosols, creams
and foams
○ Manufacturing overages vs. stability overages