QUALITY CONTROL 2

CHAPTER 1-3 SUMMARY

(LECTURE)

Introduction:

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.
 everybody’s business.

QUALITY CONTROL
 tool, which gives assurance that a product conforms to standards and
specifications through a system of inspection, analysis, and action.
 describe functions within total control effort responsible for on-line or in-process testing
 system established at conception of a new product, during production of the batch, and
during distribution of the commercial package.
 combination of those administrative and technical procedures, which must be used to
produce and deliver a safe, pure, and effective product to the end user.
QUALITY ASSURANCE
 used to describe the overall organizational body designed to assure product quality
 in title potential benefits derived from a quality control system are as follows:
 1. System minimizes or eliminates the risk of marketing unsafe products.
 2. Guarantees conformance to regulatory requirements.
 3.Guarantees product efficacy.
 4. Reduces operating costs.
 5. Reduces operating losses.
 6. Produces higher employee morale.
 7. Motivates the pharmaceutical/medical professions to sell or prescribe the
product.

ORGANIZATION OF QUALITY CONTROL

 Organization part of a manufacturing firm
 each segment is expected to finetune its functions and responsibilities
 effective coordination is called for among its personnel, equipment, building and
inventory of materials
 . All these activities are performed towards the production of a drug or cosmetic
of the highest standard and at the lowest cost

 Common division in manufacturing firm under general manager
1. Finance
2. Production
 3. Quality Assurance (Quality Control)
4. Marketing (optional in a third party contract manufacturer)
 All manufacturing
 must be done in compliance with Current Good Manufacturing Practice
(CGMP). For this reason, Administrative Order No. 220, s. 1974 is
included in the Appendix in its entirety.
 CGMP enforcing
 achieve the desired goal of delivering
SEP
 safe,
 effective product
 pure
at the lowest cost to the consumer
 specific group must be organized to be the core of the company’s
quality audit program
 quality control department is organized to maintain quality of products
to a prescribed level.
 Each pharmaceutical or cosmetic company has an organizational structure, which differ
somewhat from those if other companies in scope and responsibilities. Fig. 1-2 shows a
typical organization within the quality control department.

Materials Inspection Section

 Inspectors
 alert individuals had experience and familiar with physical
characteristics of materials they sample and are well versed in
sampling techniques.
 Functions of this section are:
1. To sample and examine all raw materials received.
2. To sample and conduct physical tests on:
a. All shipments of packaging materials
b. All manufacturing, filling and packaging operations
3. To maintain periodic examination on the quality of inventories
throughout all phases of storage, shipping and distribution.
4. To perform an audit which is independent of the work done by
production personnel?
 Inspection stations
 placed in area of operation, viz., warehouse, manufacturing and
packaging areas
Analytical Laboratory
 should be in an accessible area and protected from noise and vibration common
to manufacturing operations.
 to perform physical and chemical analysis, analysts should know:
 usual gravimetric
  volumetric analysis.
 should be skillful in handling instruments for ultraviolet and
infrared spectrophotometry, non-aqueous titrimetry,
autoanalysis, polarography, x-ray diffraction, x-ray fluorescence,
spectrophotoflourimetry, radioactive tracer techniques and
chromatography, viz.: column, gas, paper, thin layer and high
performance liquid chromatography
Biological Testing Laboratory
 Staff
 should be well trained and experienced in both simple and
complex microbiological procedures and biological interactions.
 should possess a high degree of skill and judgment in order to
perform the job.
Veterinarian
 recommended to supervise the care and maintenance of the various
species of animals used in the tests.
Functions:
1. Perform and evaluate microbiological and pharmacological assays, sterility, pyrogen
and bacteriological tests, irritation, safety or acute toxicity tests.
2. Conduct environmental monitoring.
 Sterile conditions
 should be provided for areas where biological tests are conducted.
 noise should be precluded from areas where animals are used
 animal house should be maintained as a separate unit from the main
laboratory, if necessary.

Specification and Analytical Development

 should have firm background not only in the principles of quality control and
analytical procedures but also in manufacturing, research, product development and
in statistics in order to perform the following functions:
1. Coordinate with research, product development, production, sales and
management towards improvement of a product.
2. Establish specifications for raw and packaging materials.
3. Validate existing and tentative procedures of testing.
4. Establish specifications based on validated procedures.
5. Develop new assay methods for in-house use.
6. Develop and improve specifications for quality characteristics of the final product
being manufactured.
Quality Coordination Office
 should be accessible to all manufacturing and packaging operations since
documentation is its main responsibility.
 Functions
Maintain, Furnish, Investigate, Call, Provide, Maintain
1. Maintain and store records that represent the history of the batch from start to finish.
These records include the batch and master formula records, raw material analytical
records, printed and packaging material inspection reports and retention files.
2. Furnish data that will aid in analyzing product performance in the market. These
documents are the stability studies and returned goods reports.
3. Investigate customer complaints or inquiries on product quality and to forward the
results of the investigations in the form of technical reports to the sales organization.
4. Call the attention of the appropriate development group any aspect that provides a
basis for improvement of a product for consideration and action.
5. Provide data that give scientific and legal status, i.e., data generated from the use of
recognized standard compendia. This is essentially a function of the distribution section
or warehouse.
6. Maintain and develop SOP’s.

HIGHER MANAGEMENT

Scientific V.P Manufacturing V.P

Research and Purchasing

Development
Production
Quality
Control
Warehouse

Materials Inspection Section Maintenance

Analytical Laboratory

Biological Testing Laboratory

Specifications & Analytical

Development

Research on one manufacturing company and be able to give the organizational chart
STANDARDS AND SPECIFICATIONS
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
Quality characteristics
 interpreted by descriptive words and measurements. Characteristics are subject to
variation.
Quality variation
 not confined within a specific range, tolerance or limit, will grow to uncontrolled
magnitude and will encourage the proliferation of errors; thus producing a defective
product.
 To avoid producing a defective product, standards and specifications are developed to
serve as a basis for accepting or rejecting a product. In a product, these must cover the
following points:
1. Formula. This is concise and precise statement of the ingredients that comprise
the product, together with the percentage and/or weight of each.
2. Raw material specification. This should enumerate the characteristics of all the
materials that go into the product and the permissible range of purity of each
ingredient. Deviation beyond this range may be expected to cause failure of the
product to function as planned or, at least, result in an undesirable lack of
uniformity. Standard compendia like the USP, NF, BP, BPC, Merck Index, etc.,
provide this valuable information.
3. Standard operating procedure. This is a step by step method on how to go about
a job. It must spell out all information and instructions that assure that variations
in production from day to day and week to week will be held to within acceptable
established ranges
4. Finished product specification. This should cover all characteristics that affect the
proper performance, purity, safety and stability of the product. Tolerances may
be minimum, maximum, or both, depending on the nature of the situation.
5. Packaging material standard. This should be set for everything that goes around
the product, i.e., bottles, cans, aluminum foil, cellophane, jars, caps, cap liners,
labels, printed inserts, cartons, wrapping papers, and shipping cases. Packaging
must be considered with the following points in mind:
a. The units may have to run on a high-speed line.
b. They may involve a complicated assembly.
c. The package may be functional.
d. The package must be completely compatible with the product.
e. The package must protect the product and assure its stability.
f. The package must ship well.
6. Testing Methods. These are indispensable in assuring conformity to standards.
Since they play such a vital role, testing procedures must be standardized so that
 they yield results of comparable precision and accuracy in the hands of different
operators and laboratories. The tests must be validated to ensure precision and
accuracy on application.
An overview of USP/NF
 The United States Pharmacopeia (USP) is the official public standards-setting
authority for all prescription
and over-the-counter medicines, dietary supplements, and other healthcare products
manufactured and
sold in the United States.
 USP sets standards for the quality of these products and works with healthcare
providers to help them
reach the standards. USP's standards are also recognized and used in more than 130
countries. These
standards have been helping to ensure good pharmaceutical care for people throughout
the world for more
than 185 years.
 USP is an independent, science-based public health organization. As a self-
sustaining nonprofit
organization, USP is funded through revenues from the sale of products and services
that help to ensure
good pharmaceutical care.
 USP's contributions to public health are enriched by the participation and oversight of
volunteers
representing pharmacy, medicine, and other healthcare professions as well as
academia, government, the
pharmaceutical industry, health plans, and consumer organization
 Many other countries require the use of high-quality standards such as USP's to
assure the quality of
medicines and related products. USP disseminates its standards to pharmaceutical
manufacturers,
pharmacists, and other users through its USP–NF and other publications, official USP
Reference
Standards materials, and Pharmacopeial Education courses.
 USP also conducts verification programs for dietary supplement ingredients and
products. These programs
involve independent testing and review to verify ingredient and product integrity, purity,
and potency for
manufacturers who choose to participate
 The USP–NF is a single-volume combination of two official compendia, the United
States Pharmacopeia
(USP) and the National Formulary (NF).
 Monographs for drug substances and preparations are featured in the USP.
Monographs for dietary
supplements and ingredients appear in a separate section of the USP. Excipient
monographs are in the
NF.
 A monograph includes the name of the ingredient or preparation; the definition;
packaging, storage, and
labeling requirements; and the specification.
 The specification consists of a series of tests, procedures for the tests, and
acceptance criteria.
These tests and procedures require the use of official USP Reference Standards.
 Medicinal ingredients and products will have the stipulated strength, quality, and
purity if they conform
to the requirements of the monograph.
 Tests and procedures referred to in multiple monographs are described in detail in the
USP–NF
general chapters.
Refer to sample monograph below

An Illustrated Guide to USP Standards Using the Acetaminophen and Acetaminophen

Capsules Monographs