QUALITY ASSURANCE &
QUALITY MANAGEMENT CONCEPTS

Khushbu Patel

M.Pharm.

Assistant Professor

www.DuloMix.com 1

INTER-RELATION BETWEEN GMP & QA &
QC

www.DuloMix.com 2

QA, GMP & QC inter relationship

QA- ensuring that product will be of required quality

GMP – Product are consistently manufactured to a
appropriate quality

QC – Concerned with sampling, specification, testing,
documentation and release procedure

www.DuloMix.com 3

1.QUALITY MANAGEMENT IN THE DRUG INDUSTRY

(WHO)

In the drug industry at large, quality management is
usually defined as the aspect of management function
that determines and implements the “quality policy”, i.e.
the overall intention and direction of an organization
regarding quality, as formally expressed and authorized
by top management.

The basic elements of quality management are:

 an appropriate infrastructure or “quality system”,
encompassing the organizational structure, procedures,
processes and resources;

 systematic actions necessary to ensure adequate
confidence that a product (or service) will satisfy given
requirements for quality. The totality of these actions is
termed “quality assurance”.

www.DuloMix.com 4

Within an organization, quality assurance
serves as a management tool. In contractual
situations, quality assurance also serves to
generate confidence in the supplier.

The concepts of quality assurance, GMP and
quality control are interrelated aspects of quality
management. They are described here in order
to emphasize their relationship and their
fundamental importance to the production and
control of pharmaceutical products.

www.DuloMix.com 5

QUALITY ASSURANCE:

DEFINITIONS
 Quality assurance is a wide-ranging concept covering all

matters that individually or collectively influence the
quality of a product. With regard to pharmaceuticals,
quality assurance can be divided into major areas:
development, quality control, production, distribution,
and inspections. (WHO)

 ISO 9000 define QA as a Part of quality management
focused on providing confidence that quality
requirements will be fulfilled.

 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.

 Quality assurance therefore incorporates GMP and
other factors, including those outside the scope of this
guide such as product design and development.

www.DuloMix.com 6

RESPONSIBILITIES 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

(c) managerial responsibilities are clearly specified in job
descriptions

(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

www.DuloMix.com 7

(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

www.DuloMix.com 8

(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.

www.DuloMix.com 9

QUALITY CONTROL:
 A system of maintaining standards in manufactured

products by testing a sample of the output against the
specification.

 ISO 9000 defines quality control as “A part of quality
management focused on fulfilling quality requirements”

 It is that part of GMP concerned with sampling,
specification and testing, documentation and release
procedures which ensure that the necessary and
relevant tests are performed and the product is released
for use only after ascertaining it’s quality.

www.DuloMix.com 10

RESPONSIBILITIES OF QC:

 QC is responsible for day to day control of quality within
the company

 QC is responsible for analytical testing of incoming raw
materials and inspection of packaging components,
including labeling

 They conduct in-process testing when required, perform
environmental monitoring, and inspect operations for
compliance.

 They also conduct the required tests on finished dosage
form

 QC plays a major role in the selection of qualified vendors
from whom raw materials are purchased.

 The environmental areas for manufacturing of various
dosage forms are tested and inspected by QC department

www.DuloMix.com 11

DIFFERENCE BETWEEN QA AND QC

 QA is process oriented and QC is product oriented

 QA is a set of activities for ensuring quality in the
processes by which products are developed

QC is a set of activities for ensuring quality in the
products. The activities focus on identifying defects in
the actual products produced

 QA is a managerial tool while QC is a corrective tool

 QA aims to prevent defects with a focus on the process
used to make the product while QC aims to identify and
correct defects in the finished products

 QA goal of QA is to improve development and test
processes so that defects do not arise when the product
is being developed

while Goal of QC is to identify defects after a product is
developed and before it’s released

www.DuloMix.com 12

 A QA aim is to prevent the defect.

While A QC aim is to identify and improve the defects.
 QA is the technique of managing the quality.

While QC is method to verify the quality.

 QA does not involve executing the program.

WhileQC always involves executing the program.

 All team members are responsible for QA.

While Testing team is responsible for QC.

 QA e.g. Verification.

While QC e.g. Validation.

 QA means Planning for doing a process.

QC Means Action for executing the planned process.

 Statistical Technique used on QA is known as
Statistical Process Control (SPC.)

www.DuloMix.com 13

 Statistical Technique used on QC is known as
Statistical Quality Control (SPC.)

 QA makes sure you are doing the right things.

QC makes sure the results of what you’ve done are
what you expected.

 QA Defines standards and methodologies to followed in
order to meet the customer requirements.

QC ensures that the standards are followed while
working on the product.

 QA is the process to create the deliverables.

QC is the process to verify that deliverables.

 QA is responsible for full software development life
cycle.

QC is responsible for software testing life cycle.
www.DuloMix.com 14

GOOD MANUFACTURING PRACTICE (GMP)

 Good Manufacturing Practice is a part of quality
assurance which ensure that the products are
consistently produced and controlled according to quality
standards appropriate to their intended use.

 GMP – A set of principles and procedures which, when
followed by manufacturers for the therapeutic goods,
helps ensure that the products manufactured will have
the required quality

 It is designed to minimize the risks involved in any
pharmaceutical production that cannot be eliminated
through testing the final product.

www.DuloMix.com 15

GMP COVERS:

 All aspects of production; from the starting materials,
premises and equipment to the training and personal
hygiene of staff.

 Detailed, written procedures are essential for each
process that could affect the quality of the finished
product.

 There must be systems to provide documents proof that
correct procedures are consistently followed at each
step in the manufacturing process every time a product
is made.

www.DuloMix.com 16

WHO GOOD MANUFACTURING PRACTICES FOR

PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES

 GMP is that part of quality management which ensures
that products are consistently produced and controlled
according to the quality standards appropriate to their
intended use and as required by the marketing
authorization, clinical trial authorization or product
specification. GMP is concerned with both production
and QC. GMP is aimed primarily at managing and
minimizing the risks inherent in pharmaceutical
manufacture to ensure the quality, safety and efficacy of
products.

www.DuloMix.com 17

UNDER GMP:

a)All manufacturing processes are clearly defined,
systematically reviewed for associated risks in the light of
scientific knowledge and experience, and shown to be
capable of consistently manufacturing pharmaceutical
products of the required quality that comply with their
specifications;

b) Qualification and validation are performed;
c) All necessary resources are provided, including:
➢ sufficient and appropriately qualified and trained personnel,
➢ adequate premises and space,
➢ suitable equipment and services,
➢ appropriate materials, containers and labels,
➢ approved procedures and instructions,
➢ suitable storage and transport,
➢ adequate personnel, laboratories and equipment for in-

process controls;
www.DuloMix.com 18

d) Instructions and procedures are written in clear and unambiguous
language, specifically applicable to the facilities provided;

e)Procedures are carried out correctly and personnel are trained to do
so;

f) Records are made (manually and/or by recording instruments) during
manufacture to show that all the steps required by the defined
procedures and instructions have in fact been taken and that the
quantity and quality of the product are as expected. Any significant
deviations are fully recorded and investigated with the objective of
determining the root cause and appropriate corrective and preventive
action is implemented;

g) Records covering manufacture and distribution, which enable the
complete history of a batch to be traced, are retained in a
comprehensible and accessible form;

h)The proper storage and distribution of the products minimizes any risk
to their quality and takes account of good distribution practices (GDP);

i) Asystem is available to recall any batch of product from sale or supply;
j) Complaints about marketed products are examined, the causes of

quality defects investigated and appropriate measures taken in
respect of the defective products to prevent recurrence.

www.DuloMix.com 19

LISTS OF IMPORTANT DOCUMENTS IN GMP

 Policies

 Standard operating procedures SOP

 Specifications

 Master formula records MFR

 Batch manufacturing record BMR

 Manuals

 Master plans/Files

 Validation protocols

 Forms and formats

 Records