QUALITY ASSURANCE

» It is the totality of the arrangements made with the object of

ensuring that pharmaceutical products are of the quality required
for their intended use.
QA is the heart and soul of quality control
QA = QC + GMP
» The system of quality assurance appropriate to the
manufacture of pharmaceutical products should ensure
that:/ system of QA / functions of QA:
A. pharmaceutical products are designed and developed in a way that
takes account of the requirements of GMP and other associated codes
such as those of good laboratory practice (GLP) and good clinical
practice (GCP);
B. production and control operations are clearly specified in a written
form and GMP requirements are adopted;
D. arrangements are made for the manufacture, supply and use of the
correct starting and packaging materials;
E. all necessary controls on starting materials, intermediate products,
and bulk products and other in-process controls, calibrations, and
validations are carried out;
F. the finished product is correctly processed and checked, according to
the defined procedures;
G. pharmaceutical products are not sold or supplied before the
authorized persons have certified that each production batch has been
produced and controlled in accordance with the requirements of the
marketing authorization and any other regulations relevant to the
production, control and release of pharmaceutical products;
H. satisfactory arrangements exist to ensure, as far as possible, that the
pharmaceutical products are stored by the manufacturer, distributed,
and subsequently handled so that quality is maintained throughout their
shelf-life;
I. there is a procedure for self-inspection and/or quality audit that
regularly appraises the effectiveness and applicability of the quality
assurance system;
J. deviations are reported, investigated and recorded;
K. there is a system for approving changes that may have an impact on
product quality;
L. regular evaluations of the quality of pharmaceutical products should
be conducted with the objective of verifying the consistency of the
process and ensuring its continuous improvement.
 The manufacturer must assume responsibility for the quality of the
pharmaceutical products to ensure that they are fit for their
intended use, comply with the requirements of the marketing
authorization and do not place patients at risk due to inadequate
safety, quality or efficacy.
 The attainment of this quality objective is the responsibility of
senior management and requires the participation and
commitment of staff in many different departments and at all levels
within the company, the company’s suppliers, and the distributors.
 To achieve the quality objective reliably there must be a
comprehensively designed and correctly implemented system of
quality assurance incorporating GMP and quality control. It should
be fully documented and its effectiveness monitored.
 All parts of the quality assurance system should be adequately
staffed with competent personnel, and should have suitable and
sufficient premises, equipment, and facilities
 The quality of pharmaceutical products is ensured by the technical
and managerial activities of the quality system, which includes
evaluating pharmaceutical product documentation, performing or
reviewing quality-control laboratory tests, and monitoring product
performance. Managerial activities include selecting reliable
suppliers, preparing contract terms, monitoring supplier
performance, and performing inspection procedures throughout
the distribution network
The concept of quality assurance and quality control together develops
towards assuring the quality, safety and efficacy of pharmaceutical
products.
 the pursuit of quality being approached through the concept of total
quality management (TQM) system which is aimed at prevention of
defects rather than detection of defects.

QA QC
QA is the sum total of
organized arrangements which is concerned with
made with the object of sampling, specifications,
ensuring that product will be testing and within the
of the Quality required by their organization, documentation,
intended use. and release procedures which
ensure that the necessary
and relevant tests are carried
out
All those planned or
systematic actions necessary techniques and activities used to
to provide adequate fulfil the requirement of Quality
confidence that a product will
satisfy the requirements for
quality
QA is company based QC is lab based
Quality Assurance-Highlights

ORGANISATION
 A social unit of people that is structured and managed to meet a
need or to pursue collective goals.
 All organisations have a management structure that determines
relationships between the different activities and the members and
subdivided and assigns roles responsibilities and authority to carry
out a different tasks
 In establishing an organisational structure for the manufacture and
quality assurance of health and similar products, the most
 generally accepted view is that there should be two separate
persons each with overall responsibilities for production or for
quality control, neither of whom is responsible of other.

 Quality has been defined as the totality of features and

characteristics of a product or service that bears on its ability to
satisfy a given need; and Quality Assurance as all activities and
functions concerned with the attainment of quality.
 The quality of a product does not occur by accident. People
throughout an organization do not always carry out instructions, or
perform their role correctly. It is the continuing task of quality
management to deal with this situation and ensure that all
members of the industrial team are aware of their quality
responsibilities and are accountable for their actions.
 Quality must be designed into products – discipline, attitude and
inventiveness must be encouraged to create easy to make and
easy to use fool proof products. Quality must then be planned into
manufacture – methods must be devised so that the easiest way to
do the job is the right one; so that, where appropriate, worker
interest is created; and elsewhere complete control is built into the
process. Finally, quality must be built into the product – the people
concerned with the cutting, fitting and assembling must be well
trained and enthusiastically led to achieve “right first time”
 production. This is the simple overall formula, but it is by no means
simple to put into practice.
 To make quality assurance an effective part of business, Senior
Management must be clearly committed to developing and
implementing an effective Quality Policy.
 The implementation of such a policy involves everyone in the
company. It must be clearly recognized that every employee (from
board to shop floor) is responsible for ensuring that GMP and good
quality practices are achieved.
 All departments within a company must be held accountable within
their own spheres of influence for ensuring that for the selling price
of the product, the required quality standards are inherent within
the design and methods, processes specified and the materials
and equipment provided.
The Quality Executive
 The role of Quality Executive in industry is nowadays highly
specialized. The idea that the work of quality organizations was
simply that of “inspecting out” defective work which had already
been produced was widespread in the past, particularly in
management circles. Quality cannot however be achieved solely
by the Quality Executive, it depends on everyone being actively
involved.
 The Quality Executive’s contribution is essentially one of
coordinating the efforts of others to ensure the achievement of
quality by communicating information on the many aspects
affecting quality to all concerned and exercising control over
quality monitoring throughout the organization. It must be the
task/goal of all managers to ensure that the quality function of their
own departments is fulfilled. This places a heavy responsibility on
all senior managers.
The Responsibility of Senior Management
 To achieve the desired quality standard means that management
organization and management thinking has to be well structured
so as to ensure that quality and reliability figure appropriately in
corporate planning.
 It is essential for any manager not only to have a good
appreciation of the fundamentals of quality and reliability, but also
fully understand his/ her own responsibility for the management
 and achievement of quality and reliability. Only by having this
knowledge can he/she determine the correct levels of resources
which must be deployed.

» To determine the quality and reliability requirements of customers

or the intended market place;
» To control the design and manufacture of goods to meet these
requirements;
» To provide the customers with adequate confidence those goods
when received and put into operation will conform to their
specifications/requirements.
Managers should be aware that the quality of their products is a vital
factor in the continuing competitiveness and profitability of their
company. Not only should they be concerned with producing products
at the right price and at the right time, but they should also ensure that
they are marketing the right product and that it will fully meet the
customer’s and regulatory compliance requirements
Finally, senior management has the ultimate responsibility to ensure an
effective quality assurance system is in place to achieve the product
quality and reliability
BUILDING DESIGN: explain d below points briefly

Loading dock
Ancillary areas
1. Rest and refreshment rooms should be separate from
manufacturing and control areas.
2. Facilities for changing and storing clothes and for washing and
toilet purposes should be easily accessible and appropriate for the
number of users. Toilets should not communicate directly with
production or storage areas.
3. Maintenance workshops should if possible be separated from
production areas. Whenever parts and tools are stored in the
production area, they should be kept in rooms or lockers reserved
for that use.
4. Animal houses should be well isolated from other areas, with
separate entrance (animal access) and air-handling facilities
Storage areas
1. Storage areas should be of sufficient capacity to allow orderly
storage of the various categories of materials and products with
proper separation and segregation: starting and packaging
materials, intermediates, bulk and finished products, products in
quarantine, and released, rejected, returned or recalled products.
2. Storage areas should be designed or adapted to ensure good
storage conditions. In Particular, maintained within acceptable they
should be clean, dry, sufficiently temperature limits. Where lit and
special storage conditions are required (e.g. temperature,
humidity) these should be provided, controlled, monitored and
recorded where appropriate.
3. Where quarantine status is ensured by storage in separate areas,
these areas must be clearly marked and their access restricted to
authorized personnel. Any system replacing the physical
quarantine should give equivalent security.
4. Segregation should be provided for the storage of rejected,
recalled, or returned materials or products.
5. Highly active and radioactive materials, narcotics, other dangerous
drugs, and substances presenting special risks of abuse, fire or
explosion should be stored in safe and secure areas.
6. Printed packaging materials are considered critical to the
conformity of the pharmaceutical product to its labelling and
 special attention should be paid to sampling and the safe and
secure storage of these materials.
7. There should normally be a separate sampling area for starting
materials. (If sampling is performed in the storage area, it should
be conducted in such a way as to prevent contamination or cross-
contamination.)
Weighing areas
1. The weighing of starting materials and the estimation of yield by
weighing should be carried out in separate weighing areas
designed for that use, for example with provisions for dust control.
Such areas may be part of either storage or production areas.
Production areas
2. In order to minimize the risk of a serious medical hazard due to
cross contamination, dedicated and self-contained facilities must
be available for the production of particular pharmaceutical
products, such as highly sensitizing materials (e.g. penicillin’s) or
biological preparations (e.g. live microorganisms). The production
of certain other highly active products, such as some antibiotics,
hormones, cytotoxic substances and certain non-pharmaceutical
products, should not be conducted in the same facilities.
3. Premises should preferably be laid out in such a way as to allow
the production to take place in areas connected in a logical order
corresponding to the sequence of the operations and to the
requisite cleanliness levels.
4. The adequacy of the working and in-process storage space should
permit the orderly and logical positioning of equipment and
materials so as to minimize the risk of confusion between different
pharmaceutical products or their components, to avoid cross-
contamination, and to minimize the risk of omission or wrong
application of any of the manufacturing or control steps.
5. Where starting and primary packaging materials and intermediate
or bulk products are exposed to the environment, interior surfaces
(walls, floors and ceilings) should be smooth and free from cracks
and open joints, should not shed particulate matter, and should
permit easy and effective cleaning and, if necessary, disinfection.
6. Pipework, light fittings, ventilation points and other services should
be designed and sited to avoid the creation of recesses that are
 difficult to clean. As far as possible, for maintenance purposes,
they should be accessible from outside the manufacturing areas.
7. Drains should be of adequate size and designed and equipped to
prevent back-flow. Open channels should be avoided where
possible, but if they are necessary they should be shallow to
facilitate cleaning and disinfection.
8. Production areas should be effectively ventilated, with air control
facilities appropriate to the products handled, to the operations
undertaken and to the external environment. These areas should
be regularly monitored during both production and non-production
periods to ensure compliance with their design specifications.
9. Premises for the packaging of pharmaceutical products should be
specifically designed and laid out so as to avoid mix-ups or cross-
contamination
Quality control areas
1. Quality control laboratories should be separated from production
areas. Areas where biological, microbiological or radioisotope test
methods are employed should be separated from each other.
2. Quality control laboratories should be designed to suit the
operations to be carried out in them. Sufficient space should be
given to avoid mix-ups and cross-contamination. There should be
adequate suitable storage space for samples, reference standards
(if necessary, with cooling), solvents, reagents and records.
3. The design of the laboratories should take into account the
suitability of construction materials, prevention of fumes and
ventilation. There should be separate air supply to laboratories and
production areas.
4. A separate room may be needed for instruments to protect them
against electrical interference, vibration, contact with excessive
moisture and other external factors, or where it is necessary to
isolate the instruments.
Personnel and training in the supply system
Central to the operation of most well-run pharmaceutical supply
systems is at least one qualified pharmacist with some training or
experience in industrial pharmacy and procurement. Such an individual
can be invaluable in establishing and overseeing quality-control
practices suited to local requirements.
This person should participate in—
• Selecting medicines • Setting technical specifications for
pharmaceutical contracts • Reviewing supply offers and selecting
suppliers • Reviewing storage and transportation facilities • Coordinating
any pharmaceutical quality testing and helping to train the inspectors
who check pharmaceutical shipments
In some government systems, qualified pharmacists are employed at all
levels, including the district hospitals, and they are expected to oversee
local storage and transportation conditions.
In addition, they report problems or questions concerning individual
medicines to the main office. In other countries, locally trained
dispensers are responsible for much of the day-to-day work and must
be trained to detect and report quality problems. Some countries must
rely on staff that has not received any technical training in
pharmaceutical management.
In addition to pharmacists and pharmaceutical assistants, other staff
members involved in quality assurance need training and supervision
as a part of quality assurance efforts.
• Physicians, health administrators, and health system officials must
know about the factors that 1influence pharmaceutical quality to make
informed decisions about supply sources and to monitor and promote
quality assurance in their facilities.
• Port-clearing personnel should be trained to identify the categories of
pharmaceuticals requiring special storage and transport conditions.
• Clerks responsible for inspecting pharmaceutical shipments should
receive formal training in inspection procedures.
• Pharmaceutical inspectors must be familiar enough with
pharmaceutical labelling and packaging materials to determine whether
contract conditions regarding pharmaceutical dosage, packaging, and
labelling have been met.
• Staff involved with local repackaging should be trained to ensure
pharmaceutical quality and to follow good practices, especially
regarding label control.
• Physicians, nurses, and paramedical personnel handling
pharmaceuticals throughout the health system need to know about the
factors that influence pharmaceutical quality and what they can do to
ensure that the medicines dispensed to patients are safe and effective.