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Chapter 1-3 Lecture PDF
Chapter 1-3 Lecture PDF
- Quality is the 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 CONTROL
- Quality control is a tool, which gives the assurance that a product conforms to standards and specifications
through a system of inspection, analysis, and action.
- Quality Control (QC) is used to describe the functions within the total control effort responsible for on-line or in-
process testing
- Quality is everybody’s business.
- Quality control system is established at the conception of a new product, during production of the batch, and
during distribution of the commercial package.
- This system is a 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
- Quality Assurance (QA) has been used to describe the overall organizational body designed to assure product
quality, while the title.
The potential benefits derived from a quality control system are as follows:
1. The system minimizes or eliminates the risk of marketing unsafe products.
2. It guarantees conformance to regulatory requirements.
3. It guarantees product efficacy.
4. It reduces operating costs.
5. It reduces operating losses.
6. It produces higher employee morale.
7. It motivates the pharmaceutical/medical professions to sell or prescribe the product.
- Part of a manufacturing firm is a defined organization. Each segment of this organization is expected to fine-
tune its functions and responsibilities. An 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.
o In a manufacturing firm, it is a common to have the following divisions under a 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.
- In enforcing CGMP to achieve the desired goal of delivering a safe, pure and effective product at the lowest
cost to the consumer, a specific group must be organized to be the core of the company’s quality audit
program. Thus, the quality control department is organized to maintain quality of products to a prescribed
level.
- Inspection stations are placed in the area of operation, viz., warehouse, manufacturing and packaging areas.
Analytical Laboratory
- The analytical laboratory should be in an accessible area and protected from noise and vibration common to
manufacturing operations.
- In order to perform physical and chemical analysis, the analysts should know the usual gravimetric and volumetric
analysis. Furthermore, they 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.
- The staff in a biological testing laboratory should be well trained and experienced in both simple and complex
microbiological procedures and biological interactions. They should possess a high degree of skill and judgment in
order to perform the job. A veterinarian is recommended to supervise the care and maintenance of the various species
of animals used in the tests. The functions of this laboratory are:
1. To perform and evaluate microbiological and pharmacological assays, sterility, pyrogen and bacteriological
tests, irritation, safety or acute toxicity tests.
2. To 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. An animal house should be maintained as a separate unit from the main
laboratory, if necessary.
1. To coordinate with research, product development, production, sales and management towards improvement
of a product.
2. To establish specifications for raw and packaging materials.
3. To validate existing and tentative procedures of testing.
- This section should be accessible to all manufacturing and packaging operations since documentation is its main
responsibility. The functions of this section are:
1. To 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. To be able to furnish data that will aid in analyzing product performance in the market. These documents are
the stability studies and returned goods reports.
3. To 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. To call the attention of the appropriate development group any aspect that provides a basis for improvement
of a product for consideration and action.
5. To 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. To maintain and develop SOP’s.
HIGHER MANAGEMENT
Research &
Development Purchasing
Production
Quality
Control
Warehouse
Analytical Laboratory
Research on one manufacturing company and be able to give the organizational chart
Quality is the 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 are interpreted by descriptive words and measurements. Characteristics are
subject to variation.
Quality variation which is 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:
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.
Official References:
United States Pharmacopoeia and National Formulary
Japan Pharmacopeia
British Pharmacopeia
European Pharmacopeia
International Pharmacopeia
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.