 Application of quantitative analytical chemistry to:

 The analysis and determination of purity and quality

of official drugs and chemicals.
 The analysis of chemical constituents found in the
human body.
 The analysis of medicinal agents and their
metabolites.

Quality as Applied to Drug Products:

Sum of all factors which contribute directly or
indirectly to the safety, effectiveness and reliability of
the product.
 Establishment, documentation and implementation
of an effective system for managing quality which
involves active participation of management and
appropriate personnel.
Quality Assurance
Covers all matters that influence the quality of a
product.
Ensures that pharmaceutical products are of the
quality required for their intended use.
Incorporates GMP and other factors i.e. product
design and development.
cGMP
Part of QA; ensures products are consistently
produced and controlled according to specs or
quality standards appropriate for intended use
 Part of cGMP; concerned with sampling, specs, testing,
documentation and release procedures associated with the
laboratories; follows international and local guidelines
 Guarantees within reasonable limits that a drug product is:
 Free of impurities
 Stable
 Contains the amount of active ingredient/s as stated on
the label
 Provides optimal release of active ingredient/s when the
product is administered
Pharmaceutical Assaying
 Determination of strength, potency & percentage purity
of pharmaceutical products
Sets the standards for quality
Publishes the USP/NF
Legally recognize compendiums of standards for
drugs, which include assays and tests for
determination of strength, quality and purity.
Monograph
Specifies the tests to be conducted for a particular
material or product, the procedures and the
references for its details and the expected results.
Certificate of Analysis
Contains all the tests conducted on a particular
material or product to show compliance or non-
compliance with established standards or
specifications
Assures that policies inept to economic issues
associated with manufacturing and distribution
of products

With regulatory agencies, serve as final

authority in product acceptance or rejection

Identify and prepare SOP’s relative to QC

Audit and quality monitoring

Testing of RM’s and representative samples’
compliance

In-process tests

Monitoring of environmental conditions

Control packaging components

Main Areas:
RMQC, IPQC and FPQC
Capacity of the product to remain:

Physically Stable

Chemically Stable

Microbiologically Stable

Therapeutically Stable

Toxicologically Stable

within specifications
Established to assure identity, strength, quality
and purity
Products must have the same properties and
characteristics from the time of manufacture
until its use.
Minimum acceptable potency level: 90%

Errors in estimating expiration date:

a.) alpha error: too early
b.) beta error: too late
1.) Volumetric Analysis
Determination of the volume of a standard solution required to
react with a given amount of the substance to be analyzed.
2.) Physicochemical Methods
Analysis based on physical or chemical properties of the
substance to be analyzed.
3.) Gravimetric Analysis
Separation of the constituent in its natural state or in the form of
a compound with definite composition to be determined, by
extraction, precipitation or other means, and then weighing of
the resulting product.
4.) Special Methods
Analysis which require a distinct type of technique.
 Exactly measure a substance’s purity when
combined with qualitative tests

 Hence, a complete analysis requires not only

quantitative determinations but also qualitative
tests to determine strength, potency and purity
of a drug or pharmaceutical product.

 Mastery of theoretical considerations is required

and should be applied throughout each step of
analytical procedures.