INTRODUCTION

Life is short, and the art long; the occasion fleeting;
experience fallacious, and judgment difficult. The
physician must not only be prepared to do what is
right himself, but also to make the patient, the
attendants, and externals cooperate." Thus,
Hippocrates, the father of modern medicine,
epitomized the art of the physician. "To do what is
right" in terms of quality control and prevention has
far-reaching implications, not only for physician,
but for "the patient, the attendants, and externals."
In keeping with this sublime philosophy, this article
focuses on the assurance of Quality as a part of
regulated Pharma industry.

The pharmaceutical quality control laboratory serves
one of the most important functions in pharmaceutical
production and control. A significant portion of the
CGMP regulations (21 CFR 211) pertain to the
quality control laboratory and product testing. Similar
concepts apply to bulk drugs.

Quality Assurance

Quality assurance covers all activities from design,
development, production, installation, servicing and
documentation. This introduced the rules: "fit for
purpose" and "do it right the first time". It includes
the regulation of the quality of raw materials,
assemblies, products and components; services related
to production; and management, production, and
inspection processes.

One of the most widely used paradigms for QA
management is the PDCA (Plan-Do-CheckAct)
approach, also known as the Shewhart cycle
Quality control is a process employed to ensure a

certain level of quality in a product or service. It
may include whatever actions a business deems
necessary to provide for the control and verification
of certain characteristics of a product or service. The
basic goal of quality control is to ensure that the
products, services, or processes provided meet
specific requirements and are dependable,
satisfactory, and fiscally sound.

Essentially, quality control involves the examination
of a product, service, or process for certain minimum
levels of quality. The goal of a quality control team
is to identify products or services that do not meet
a company's specified standards of quality. If a
problem is identified, the job of a quality control
team or professional may involve stopping production
temporarily. Depending on the particular service or
product, as well as the type of problem identified,
production or implementation may not cease entirely.
Usually, it is not the job of a quality control team or
professional to correct quality issues. Typically, other
individuals are involved in the process of discovering
the cause'of quality issues and fixing them. Once
such problems are overcome, the product, service,
or process continues production or implementation
as usual.

Quality control can cover not just products, services,
and processes, but also people. Employees are an
important part of any company. If a company has
employees that don't have adequate skills or training,
have trouble understanding directions, or are
misinformed, quality may be severely diminished.
When quality control is considered in terms of human
beings, it concerns correctable issues. However, it
should not be confused with human resource issues.
Often, quality control is confused with quality
assurance. Though the two are very similar, there

Pharmaceutical Quality Assurance & Control

Ghulam Sarwar1 and M. Shakil Siddiqui1

1Faculty of Pharmacy Jinnah University for Women Karachi Pakistan

*Corresponding author: g-sarwaar@hotmail.com

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are some basic differences. Quality control is
concerned with the product, while quality assurance
is process-oriented.

Even with such a clear-cut difference defined,
identifying the differences between the two can be
hard. Basically, quality control involves evaluating
a product, activity, process, or service. By contrast,
quality assurance is designed to make sure processes
are sufficient to meet objectives. Simply put, quality
assurance ensures a product or service is
manufactured, implemented, created, or produced
in the right way; while quality control evaluates
whether or not the end result is satisfactory.

Quality Control:
The term quality control refers to the sum of all
procedures undertaken to ensure the identity and
purity of a particular pharmaceutical. Such procedures
may range from the performance of simple chemical
experiments which determine the identity and
s c r e e n i n g  f o r  t h e  p r e s e n c e  o f  p a r t i c u l a r
pharmaceutical substance (thin layer chromatography,
infrared spectroscopy, etc.), to more complicated
requirements of pharmacopoeial monographs.
Activities extend to the area of quality control
laboratories (good laboratory management practices,
models, e.g. for certificate of analysis and lists of
laboratory equipment, and an external assessment
scheme.

It is defined as all measures to be taken during
manufacturing designed to ensure the uniform outputs
of pharmaceutical products conforming to established
specifications of identity, strength, purity and other
characteristics such as potency, safety, and toxicity.

Quality Assurance:
QA is defined as a procedure or set of procedures
intended to ensure that a product or service under
development (before work is complete, as opposed
to afterwards) meets specified requirements. QA is
sometimes expressed together with QC as a single
expression, quality assurance and control (QA/QC).
Quality assurance, or QA for short, is the activity of
providing evidence needed to establish quality in

work, and that activities that require good quality
are being performed effectively. All those planned
or systematic actions necessary to provide enough
confidence that a product or service will satisfy the
given requirements for quality.

For products, quality assurance is a part and consistent
pair of quality management offering supposedly fact-
based external confidence to customers and other
stakeholders that a product meets needs, expectations,
and other requirements. QA claims to assure the
existence and effectiveness of procedures that attempt
to make sure - in advance - that the expected levels
of quality will be reached.

Failure testing
A valuable process to perform on a whole consumer
product is failure testing, the operation of a product
until it fails, often under stresses such as increasing
vibration, temperature and humidity. This exposes
many unanticipated weaknesses in a product, and
the data is used to drive engineering and
manufacturing process improvements. Often quite
simple changes can dramatically improve product
service, such as changing to mould-resistant paint
or adding lock-washer placement to the training for
new assembly personnel.

Statistical control
Many organizations use statistical process control
to bring the organization to Six Sigma levels of
quality, in other words, so that the likelihood of an
unexpected failure is confined to six standard
deviations on the normal distribution. This probability
is less than four one-millionths. Items controlled
often include clerical tasks such as order-entry as
well as conventional manufacturing tasks.
Traditional statistical process controls in
manufacturing operations usually proceed by
randomly sampling and testing a fraction of the
output. Variances of critical tolerances are
continuously tracked, and manufacturing processes
are corrected before bad parts can be produced.

Total quality control
Total Quality Control is the most necessary inspection

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control of all in cases where, despite statistical quality
control techniques or quality improvements
implemented, sales decrease.

The major problem which leads to a decrease in
sales was that the specifications did not include the
most important factor, "What the customer required".
The major characteristics, ignored during the search
to improve manufacture and overall business
performance were:

1. Reliability
2. Maintainability
3. Safety

As the most important factor had been ignored, a
few refinements had to be introduced:

1. Marketing had to carry out their work properly
a n d  d e f i n e  t h e  c u s t o m e r ' s  s p e c i f i c a t i o n s .

2. Specifications had to be defined to conform to
these requirements.

3. Conformance to specifications i.e. drawings,
standards and other relevant documents, were
introduced during manufacturing, planning and
control.

4. Management had to confirm all operators are
equal to the work imposed on them and holidays,
celebrations and disputes did not affect any of the
quality levels.

5. Inspections and tests were carried out, and all
components and materials, bought in or otherwise,
conformed to the specifications, and the measuring
 equipment was accurate, this is the responsibility
of the QA/QC department.

6. Any complaints received from the customers were
satisfactorily dealt with in a timely manner.
7. Feedback from the user/customer is used to review
designs.

8. Consistent data recording and assessment and

documentation integrity.

PACKAGING MATERIAL TESTING

Where a drug product is presented in an inadequate
package, the entire effort put into the initial
research, product development and manufacturing
control is wasted. Drug quality is directly dependent
on packaging quality. In many cases (e.g., metered-
dose aerosols), packaging quality is critical to the
overall performance and effectiveness of the drug
product. Faults in the packaging and labelling of a
drug product continue to be a major cause of drug
recalls. Packaging materials are required to be tested
or examined prior to their use in a packaging
operation to ensure that materials of acceptable
quality are used in the packaging of drugs required
to be tested or examined prior to their use in a
packaging operation to ensure that materials of
acceptable quality are used in the packaging of drugs

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