The document provides guidelines for production and validation processes. It discusses ensuring production is performed according to defined procedures and good manufacturing practices to obtain quality products. Materials must be checked upon receipt and quarantined until approved. Equipment and areas must be cleaned between products to prevent cross-contamination. Deviations from procedures require approval. Validation includes qualification of equipment, processes, cleaning, and change control to ensure reproducibility and compliance.

1. PRODUCTION

2. PRODUCTION
DEFINITION:
Production are the operation must follow
nearly defined procedures, they must completely with
the principle of good manufacturing practice in order
to obtain products of the requisite quality and be in
accordance with the relevant manufacturing and
marketing authorization.

3. PRODUCTION
GENERAL:-
Production should be performed and
supervised by competent people.
All handling of materials and products such as
receipt and quarantine, sampling, storage, labeling ,
dispensing, processing, packaging and distribution
should be done in accordance with written
procedures or instructions and where necessary
recorded.
All incoming materials should be checked to
ensure that the consignment corresponds to the
order .

4. Containers should be cleaned where
necessary and labelled with the prescribed data,
damage to container and any other problem which
might adversely affects the quality of a materials and
should be investigated, recorded & reported Quality
control Department.
Incoming materials and finished
products should be physically or administratively
quarantined immediately after receipt or processing
until they been released for use or distribution.
All materials and products should be
stored under the appropriate conditions established
by the manufactures and in a ordely fashion to permit
batch.
operation on different products should
not be carried out simultaneously or consecutively in
the same room unless there is no risk of mix up or
cross contamination.

5. At every stage processing, products &
materials should be protected from microbial
and other contamination.
When coorking with dry material &
products special precautions should be taken
to prevent the generations& dissemination of
dust. This applies particularly to the handling of
highly active or sensitaising materials.
During processing – all materials, bulk
containers major items of equipment and
appropriate rooms used should be labelled or
otherwise identified with an indication of the
product or material being processed, its
strength and batch number. This indication
should also mention the stage of production.

6. Any deviation from instruction or procedures
should be avoided as far as possible. If a
deviation occur it should be approved in writing
by a competent person with the involvement of
the Quality control Department.
Labels applied to the containers
equipment are should be clear and in the
company’s agreed ferment. It is often helpful in
addition of the working on the label to use
colours to indicate status

7. PRODUCTION
PREVENTION OF CROSS- CONTAMINATION IN
PRODUCTION
Contamination of a starting material or product
must be avoided. This risk of accidental cross
contamination arises from the uncontrolled release of
dust, gases vapour sprays or organism from materials.
The significance of this risk varies with the type of
the contaminant & of the product being contaminated.
The products in which contamination is likely to be
most of the administered by injection those given in
large doses & or over a long time.
cross contamination should be avoided by
appropriate technical or organization measures.

8. PRODUCTION:
EXAMPLE:-
A) Using closed systems of production.
B) Testing for residues & use of cleaning
status labels on equipment.
C) Providing appropriate air locks & air
extraction.
VALIDATION:
 Validation studies should
reinforce Good Manufacturing Practice
& be conducted in accordance with
defined procedures. Results &
conclusions should be recorded.

9. VALIDATION
 When any new manufacturing formula or
method of preparation is adopted steps
should be taken to demonstrate its
suitability for routine process.
 The materials which may affect
product quality and or the reproducibility of
the process should be validated.
 Process & procedure should under
go periodically critical revalidation to insure
that they remain capable of achieving the
intended results.

10. VALIDATION
STARTING MATERIAL
 The purchase of starting materials
is an important operation which should in staff
who have a particular & through knowledge
of the supplies.
 Starting materials should only be
purchased from approved supplies named in
the relevant specification & where possible
directly from the producers.
 For each delivery the containers
should be checking of package & seal & for
correspondence between note the suppliers
labels.

11. STARTING MATERIAL:
 If one material delivery is made up of
different batches each batch must be
separates for sampling, testing & release.
 The storage area and labels should bear
at least the following information.
 The designated name of the product &
the internal code reference where
applicable and a batch number given at
receipt.
 Where appropriate the status of the content
and an expiry date or a date beyond which
retesting is necessary

12. VALIDATION
 Starting materials should only be dispersed by
designated persons following a written procedure
weighed or measured into be clean & properly
labeled containers and it should be volume is
recorded.
 Materials dispensed for each batch should
be kept together & conspicuously labeled as such.

13. PROCESSING OPERATION INTERMEDIATE AND
BULKS – PRODUCTS
 Before any processing operation is started
steps should be taken to ensure that corks area
and equipment are clean & free from any starting
materials, product, residues of documents not
required for the current operation.
 Intermediate& bulk product controls & kept
under appropriate conditions and critical processes
should be validated.
 Any necessary in process controls &
environmental controls should be carried out &
recorded.
 Any significant deviation from the expected
yield should be recorded &investigated.

14. PACKAGING MATERIALS:-
 The purchase, handling & control of primary
printed packaging materials should be accorded
attention similar to that given to the starting
materials .
 Particular attention should be paid to printed
materials. They should be stored in a adequately
secure conditions such as exclude unauthorized
access cut labels & other loose printed materials
should be stored & transported in separate closed
containers so as to avoid mix up packaging
materials should be issue of the use only by
authrosed personsed following on approved
&documented produce.
 Primary packaging materials should be given
a specific reference number or identification mark.
 Out dated or absolute primary packaging
materials or printed packaging materials should be
destroyed and this disposal recorded.

15. VALIDATION
PACKAGING OPERATION
 It should be minimizing the risk of cross
contamination mix-ups or substition.
 Before packaging operations are began
step should be taken to insure that the work
area, packaging lines, printing machines & other
equipment are clean & free from any products,
materials or documents previously used if these
are not required for the current operation. The
line clearance should be performed according to
the check list.
 The name &batch number of the product
being handled should be displayed at each
packaging station line

16. PACKING OPERATION:
All products & packaging materials to be
should be checked on delivery to the packing
department for quantity, identify & conformity with
the packaging instruments.
Normally filling & sealing should be followed
as quickly as possible by labeling. If it is not the
case procedures should be applied to ensure that
no mix ups or mislabeling can occurs.
The correct performance of any printing
operation to be done separately or in the course of
the packaging should be checked & recorded.
Attention should be paid to printing by hand which
should be rechecked at regular intervals.

17. Special care should be taken when using cut label
& when over- printing is carried out off lin. Roll feed
labels in helping to avoid mix-ups
FINISHED PRODUCTS:-
Finished products should be held in quarantine
until their final release under conditions established by
the manufactures.
The evaluation of finished products and
documentations which is necessary before release of
product for sale.
After release, finished products should be stored
as usable stock under conditions established by the
manufactures.

18.  REJECTED, RECOVERED
&RETURNEDMATERIALS:-
 Rejected materials & products should be
cleanly marked as such & stored separately in
restricted area. They should either to returned to
suppliers or where appropriate reprocessed or
destroyed. What ever action is taken should be
approved &recorded by authorized personal.
 The reprocessing of rejected products
should be exceptional. It is only permitted if the
quality of final product is not affected, if the
specification are met & if it is done in accordance
with or defined and authorized procedure after
evaluation of the risks involved. Record should
be kept of the reprocessing.

19.  The recovery of all or parts of carrier batches
which conform to the required quantity by
incorporating into a batch of the same
product at a defined stage of manufacturing
should be authorized before hand.
 This recovery should be process carried
out in accordance with a defined procedures
after any possible effect on shelf life ,the
recovery should be recorded.
 The need of additional testing of any
finished products which has been
reprocessed or into which a recovered
product has been incorporated should be
considered by the Quality control
Department.

20. FINISHED PRODUCTS:
 The nature of the product any special
storage conditions it requires, into
condition & history and the time elapsed
since it was issued should all be taken
into account in this assessment where
any doubt arises over the quality of the
product it should not be considered
suitable for re-issue or re –use although
basic chemical re-processing to recover
active ingredients may be re-processing
to recover active ingredients may be
possible any action taken should be
appropriately recorded.

22. PRODUCTIVITY
Productivity refers to the physical relation between the
quality produced (out put) and the quality of resource used
in the coarse of production (input).
PRODUCTIVITY (P)=OUTPUT(O)/INPUT(I)
Output implies production while input means land,
labour capital, management etc. Productivity measures
the efficiency of the production system.
Higher productivity means producing more from a
given amount with minimum level of inputs.
In other words that more the output from one worker or
one machine (or a piece of equipment) per day shift, the
higher is the productivity.

23. PRODUCTIVITY
Higher productivity is not to be taken in
sense of higher worker or faster machines
alone but it is always elimination of waste of all
type of labour (time and skill) machine time,
capital and material management etc.
productivity=output per unit of input
Productivity and production are two different
terms. Productivity is a relation term indicating
the ration between total output and the total
input used there in on the other hand
production is in an absolute concept, which
refers to the volume of output.

24. PRODUCTIVITY
The volume of production may
increase productivity may decline due to
inefficient use of resource.
Efficient use of input may increase
productivity but the volume of production
may not increase.
Production refers to the end result
of production system where as productivity
refers it’s efficiency.

25. SIGNIFICANCE:
Benefits derived from higher
productivity are as follows:
1. It helps to cut down cost per unit and
there by improve the profits.
2. Gains from productivity can be
transferred to the consumers in from of
lower priced products or better quality
products
3. These gains can also be shared with
workers or employees by paying them at
higher rate.

26. 4. A more productive entrepreneur can have
better chances to explo it export
opportunities.
MEASUREMENT OF PRODUCTIVITY:
Productivity may be measured either on
aggregate bases or on individual basis,
which are called total and partial
productivity respectively.
Total productivity index= total outputs +
total input + total production of goods and
services + labour material capital energy
managed.

27. This index measures the efficiency in
the use of all the resources partial
productivity indices, depending upon factors
used, it measures the efficacy of individual
factor of production
Following are productivity indices for
individual inputs.
Labour productivity index=output in
unit man pours worked management
productivity index or output unit.

28. Land productivity index= total output
area used.
FACTORS INFLUENCING PRODUCTIVITY:
Productivity is outcome of several
interrelated factors, which may broadly be
divided into two categories:
1. Human factors
2. Technological factors

29.  HUMAN FACTORS:
Human nature and human behaviour
are the most significant determinants of
productivity.
Human factors include both their as
well as their willingness.
a). Ability of work: productivity of an
organisation depends upon the competence
and calibre of its people both workers and
managers ability to work is governed by
education, training, experience, aptitude
etc. Of the employes.

30. b). Willingness to works:
Motivation and morale of people are
very important factors that determine
productivity.
These are affected by wage
incentive schemes, labour participation in
management, communication system,
informal groups relations, promotion policy,
union management relations, quality of
leadership.

31. Working hours sanitation,
ventilation, subsidized canteen, company
transport etc.
TECHNOLOGICAL FACTORS:
Technological factors exert
significant influence on the level of
productivity. These include the following:
a). Size and capacity of plant
b). Product design and standardisation
c). Timely supply of materials and
automisation measures.

32. e). Repairs and maintenance.
f). Production planning and control
g). Plant layout and location
h). Materials and quality control
i). Inspection and quality control
j). Machinery and equipment used
k). Research and development
l). Inventory control

33. MANAGERIAL FACTORS:
The competence and altitudes of
manager have an important bearing on
productivity.
In many organizations, productivity is
low despite latest technology and trained
man power.
This is due to inefficient and in
different management competent and
dedicated managers can obtain extra
ordinary results from ordinary people.

34. job performance of employees
depends on the ability and willingness to
work. Management is the catalyst to create
both.
advanced technology requires
knowledgeable workers who in turn work
productivity under professionally qualified
managers.
no ideology can win a greater output
with less effort.

35. it is only through sound management
than optimum utilisation of human aid
technical resources can be secured.
NATURAL FACTORS:
Natural factors such as physical and
climate conditions exert considerable
influence on productivity, particularly in
extreme climates( too cold or too hot) tends
to be comparatively low.
Natural resources like water, fuel and
mineral influence productivity.

36. SOCIOLOGICAL FACTORS:
Social customs, traditions and
institutions influence altitudes towards work
and job. For instance, bias on the bass of
caste, religions etc. Inhibited the growth of
modern industry in some countries.
the joint family system affected
incentive to work hard in India
close ties with land and native place
hampered stability and discipline among
industrial labour.

37. POLITICAL FACTORS:
law and order, stability of
government, harmony between between
states etc are essential for high productivity
in industries taxation policies of the
government influence willingness to work,
capital formation, modernnization and
expanision of plants etc.
industrial policy affects the size, and
the capacity of plants.

38. traffic policies inefficient units also
helps to improve productivity.
ECONOMIC FACTORS:
Size of the market, banking and credit
facilities transport and communication
system etc is important factors influcing
productivity.

40. EQUIPEMENT VALIDATION
 Commonly accepted equipment validation
standards evolved over recent years through the
interpretation of food and drug administration
guideline industry conferences and periodicals.
 Pharmaceutical industry have addressed the
quality theme in our product, process, personnel
and company through validation.
 It is important to grapes this concept in order
have a successful validation program. This
equipment validation goal of a high quality
standard.

41.  Product validation, annual product quality review, change
control, standard operating procedures and training have
important role as equipment validation. Other pieces
validation puzzle, fragmented validation program.
 Quality assurance, compliance, manufacturing research
development and technical service are considered integral
areas which should understand contribute big validation
picture. Better communication and validation role dealing
with various validation project.
PROJECT SCOPE:
 Operating department will require the purchase of a piece of
equipment such as blender (or) system such as HVAC unit
either replace (or) complement existing unit (or) introduce
new investment.

42.  Requirement definition in order to initiate the
project.
 The requirement are presented to a team, which
represented at least engineering, validation, and
operating departments. Discussions will focus on
the actions pursue the various unit as available on
the market.
 The investment is a major project it might worth
considering the early involvement of FDA as team
player.

43.  The technical project manager is responsible for
gathering all the technical information in a file
which eventually housed operating department of
used equipment validation reference.
 The technical master file include all project
definition technical information and specification
equipment communication and correspondence
project time line, Purchase order, capital expanse
requests, a validation plan, etc.

44. PREQUALIFICATION:
(i) The vendor’s previous experience in implementing
similar
Project.
(ii) The vendor’s financial stability.
(iii) The vendor’s guarantee of installation, training and
short-up
support.
(iv) The client’s degree of confidence in the vendor’s ability.
(v) The level of training offered by the vender.
(vi) Performance testing vender site.
(vii) The vendor documentation and support for testing.
(viii) Definition of user need and environment.
(ix) Experience of current users. Vendors delivery.
Cost analysis.
(x) Vender’s familiarity with current good manufacturing
practices (CGMPs)

45. VALIDATION IS HAVE THREE PHACE:
(i) Installation qualification,
(ii) Operational qualification,
(iii) Performance qualification,
INSTALATION QULIFITION:
=> Installation of qualification of equipment as it is to be
installed.
=> This qualification involves the coordinate effects of the
vendor
Operating department and project team that will provide
input into
The equipment.
=> The project team may be organized different from
company to
Certain team players may wear two hats.
=> The operating department which will own ,operate, and be
responsible for any GMP issues involved with the equipment.

46. IQ STAGES THE FOLLOWING SUPPORT
GROUP SHOULD BE CONCERNED WITH
FOLLOWING AREAS:
 plant engineering is usually responsible for
providing an adequate working environment.
Issues that should concern this representative are
equipment operation, space, equipment utilities,
utility capacities.
 The equipment management group will be
responsible for the maintenance of the equipment
concern the representative are the amount of
personnel that will be needed to maintain
equipment, Filter programs, lubrication programs,
manuals change parts spare parts.
 The validation group will coordinate all of the
documentation this include sops operating
manuals.

47.  Advantage is for the validation maintain close contact with
the operating and engineering department
 As discussed previously is a good practice to begin
equipment installation qualification, if the factory
prequalification phase is utilized.
A) UTILITIES AND BUILDING SERVICES:
 Compressed air
 Electrical
 Lighting
 Plumbing
a) water
b) drains
 Steam
 Vacuum
a)cleaning
b) dust collecting

48.  Ventilation, air filtration, air heating and cooling
 Pest control
 Cleaning
B) EQUIPMENT FEATURES:
 Description
 Manufactures specification / operating manual
 Materials in product/ commodity contact
 Instrumentation
 Critical
 Non- critical [ convenience]
C) AUXILIARY EQUIPMENT FEATURES
 Description
 Manufacturing specification/ operating manual
 Purchase order
 Material in product/ commodity contact

49.  Instrumentation
A) critical
B) Non – critical
D) SPARE PARTS:
E) S.O.P.S. :
 Operating
 Set- up
 sanitation
F) LOG BOOKS
Preventative maintenance program
Cleaning and use.
G) FILTERS
H)LUBRICANTS

50. I)INSTALLATION DRAWINGS:
 The vender should have representative from
the various group that took part in manufacturing
the equipment present at the factory installation
qualification to provide assistance it questions
should areas.
 Once the prequalification is completed the
efforts move to the owners plant. The installation
with the specification. Again special emphasis
should be placed on the utilities and physical
working area.
 The validation document file. This file could
broken down into areas include installation,
Equipment, Features, spare parts, lubrication,
filter program. Standard operating program,
cleaning , logbook areas which important to use
of the equipment.

51.  The file should include information such as instrument
type, the manufacturer, such as instrument type , the
manufacturer, purpose of the instrument, location and
serial number and it description the other information
should be entered calibration frequency of the file
 The document contain information such as
equipment description, identification no’s model no’s
serial no’s location and manufacturing operation.
INSTRUMENT FEATURES:
DESCRIPTION:
 Identification number
 Model serial
 Capacity
 Location
 Utilization

52. CALIBRATION INFORMATION
 Calibration frequency
 Calibration number
 Calibration sop Title
 Calibration limits
 Minimum scale graduation
 Utilization Rang: minimum & maximum
EQUIPMENT FEATURE:
DESCRIPTION
 Identification number
 Model number
 Serial number

53.  Dimensions
 Capacity
 Location
 Purpose
 Work center numbers
MANUFACTURER SPECIFICATION/ OPERATING
MANUAL
a) Copy available
Location
b) Copy available location
PURCHASE ORDER:
a) Purchase order
b) location
MATERIAL IN PRODUCT/ COMMODITY CONTACT
[Parts- materials]

54. OPERATION QUALIFICATION:
 The completion of installation after the
operation qualification must be
performed.
 The equipment operation qualification
protocol should describe all aspects.
 The operational qualification performed
critical operating parameters one which
significant impact on the equipment ability to
operate and need process specification
satisfactorily any is challenges throuly the
use
of:
 Application s.o.p.s.
 Utilization list
 process description

55.  Test instrument utilized to conduct test
 Test instrument calibration
 Critical parameters
 Test functions list
 Test function summaries
The operation qualification should clearly
list all critical operating parameters and their
corresponding the lest function.
It should also list all test instruments
utilized to conduct the test function prescribed by
the protocol.
All applicable test instrument use in the
qualification calibrated before and after test
performed.

56. The test function performed test function
summary sheet completed dealing test
Instruments are applicable in determine
the result and conclusion.
Qualification test may entail working
placebo batch
Placebo testing would required the
validation of parenteral filling machine, tablet
compression encapsulates sugar(or) film tablet
coating system granulator branding machine
lyophilizes packing filters and other type
equipment indented for processing (or)
packaging of drug product.
An appropriate sampling plan should be
divided an approved in properly monitor the
processing of placebo batch

57. TEST FUNCTION SUMMARY:
 Equipment description
 Identification number
 Model number serial number
 Test function number
TEST DESCRIPTION
TEST INSTRUMENTATION / EQUIPMENT NEEDED
TEST PROCEDURE
RESULTS
CONCLUSIONS

58. PROCESS QUALIFICATION:
 It is considered transitional stage role of the
individual team players
 The project engineer(or) significant role perior
ensure the phase
 The validation representative assured clear
definition of equipment validation performed
various test prescribed by equipment validation
protocol, bridge between engineering and
operating department function of the project.
 They are usually several additional step to
addressed at this point. The project involve
equipment strile area the process qualification
program follow plan of additional testing prove
lethality .

59.  There issue with product dependency with the
new equipment and actual products areas under
the direct technical service necessary.
 the quality assurance and compliance
department have role through the process.
 This stage there are decision to be made from
small amount of data acceptable means operating.
 The data base of information will allow quality
assurance and the operating department to make a
better judgment of product run ability of relation of
the equipment operating parameters.