DR - ASR - Unit IB - Ph. Validation, 24-10-2019

Shri Vishnu College of Pharmacy
Autonomous
Affiliated to Andhra Univ., Visakhapatnam: Approved by AICTE, PCI, New Delhi, and recognised by APSCHE
NBA (B.Pharm) &
NAAC Accredited
Unit I B: Qualification
Content:
1. User Requirement Specification
2. Acceptance Test
A) Factory Acceptance Test
B) Site Acceptance Test
3. Types of Qualifications
- Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Requalification
4. Maintaining status
- Calibration and Preventive Maintenance,
- Change management
1
Autonomous
NBA (B.Pharm) &
NAAC Accredited
User Requirement Specification (URS)
Introduction
• The User Requirement Specification describes the business needs for what users require
from the system.
• User Requirements Specifications are written early in the validation process, typically before
the system is created. They are written by the system owner and end-users, with input from
Quality Assurance.
• Requirements outlined in the URS are usually tested in the Performance Qualification or
User Acceptance Testing.
• User Requirements Specifications are not intended to be a technical document; readers with
only a general knowledge of the system should be able to understand the requirements
outlined in the URS.
• A URS defines clearly and precisely, what the customer (i.e. you) wants the system to do,
and should be understood by both the customer and the instrument vendor.
• The URS is a living document, and must be kept updated, via a change control procedure.
• This focuses on the ‘‘what’’ rather than the ‘‘how.’’

2
Autonomous
NBA (B.Pharm) &
User Requirement Specification (URS) NAAC Accredited
A well-written URS provides several specific benefits, as it:

 Serves as a reference against which off-the-shelf commercial products are selected,
evaluated in detail, and any enhancements are defined.
 Reduces the total system effort and costs, since careful review of the document should
reveal omissions, misunderstandings and/or inconsistencies in the specification and this
means that they can be corrected easily before you purchase the system.
 Provides the input to user acceptance test specifications and/or qualification of the
system.
The URS should include:
o Introduction - including the scope of the system, key objectives for the project, and the
applicable regulatory concerns
o Program Requirements - the functions and workflow that the system must be able to
perform
o Data Requirements - the type of information that a system must be able to process
o Life Cycle Requirements - including how the system will be maintain and users trained
3
Autonomous
NBA (B.Pharm) &
• General Guidance for Writing the Requirements User Requirement Specification (URS)
NAAC Accredited
The following guidelines should be followed during the production of the specification:
Each requirement statement should be uniquely referenced and no longer than 250 words.
The URS should be consistent and requirement statements should not be duplicated or
contradicted.
Specify requirements and not design solutions. The focus should be on what is required, but
not how it is to be achieved.
Each requirement should be testable. This allows the tests to be designed as soon as the
URS is finalized.
Both the customer and the vendor must understand the document. Therefore, jargon should
be avoided wherever possible and key words are defined in a specific section in the
document.
Requirements should be prioritized as mandatory or desirable.
The URS should be modifiable but changes should be under a formal control procedure.
A URS is correct if every stated requirement has only one interpretation and is met by the
system. Unfortunately, this is very rare. 4
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Acceptance Testing
 The question of what USER ACCEPTANCE TESTING (UAT) is, becomes very important
as you reach a state of having equipment / systems delivered to a facility.
 The system/equipment is claimed to be constructed in a manner that has been defined
by a User Requirement, and constructed or fabricated in a manner that meets the
requirements of the industry and of your company specifically.
You can ill afford to accept a system or piece of equipment that does not meet these
requirements.
What is Acceptance Testing?
 User Acceptance Testing defines precisely and clearly what the user expects the
system to do. UAT documents contain information about the operating environment, the
required data for processing, and the functionality that the system should carry out.
 Completed during a FAT and a SAT
5
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Factory Acceptance Test (FAT)
What is A FAT or Factory Acceptance Test, is usually preformed at the vendor
prior to shipping to a client. The vendor tests the system in accordance with the
clients approved test plans and specifications to show that system is at a point to
be installed and tested on site.
It's an essential aspect of the whole system lifecycle and should be performed by
experienced personnel. Time spent doing a proper FAT will lead to fewer problems
when the equipment is installed.
Summary - It is the partial commissioning and qualification of equipment and/or

systems prior to their shipment from the fabricator’s site.
The FAT protocol is an inspection that includes both static and dynamic exhaustive
testing of systems or major system components to support the qualification of
equipment or a system.
The tests must verify that all functionality detailed in the User Requirements
Specification (URS) is embodied and performs as specified. It is written by the
manufacturers and executed by the client or client representative. 6
Autonomous
NBA (B.Pharm) &
FAT NAAC Accredited
 The Factory Acceptance Testing includes conducting a series of tests, which prove
that the equipment is designed, executed and works in agreement and according to
the user's requirements.
The test may include performance, physical or chemical investigation; and is
performed at site of the manufacturer of the equipment. It's very important that the
testing is approached seriously and prepared.
 The procedure of the Factory Acceptance Test must be prepared before the testing
and also presented to the equipment owner at least two weeks before the execution of
FAT, who then authorizes the process.
Moreover, the contractor of the tests will request particular items, for instance finish
factory acceptance test protocol, standard operating procedures (SOP), utilization and
servicing guides, documentation for user training, instruction for calibrating
instruments, certificates of materials and lists of data, data on qualification of
equipment, system scheme, a list the reference replacement parts etc.
7
Autonomous
NBA (B.Pharm) &
FAT NAAC Accredited
 Besides factory acceptance tests, there are some tests that must be performed at
the installation site, after the assembly of the equipment. Probably the equipment
suffered damage during assembly, transport and editing at the customer's / user's
location. Therefore, these tests performed to prove that it functions properly in its
operating environment.
 The tests are performed on the location of the user of the equipment, a its
installation and connection with all auxiliary systems. These tests are called the Site
Acceptance Test (SAT).
After successfully completing the SAT, the machine can be qualified (the process of
proving that the subject equipment or system is working properly and continuously
produce the expected results) and put into service.
 In case, the equipment proves inadequate performance during the test, in this
case, it is necessary to perform repairs of equipment and then re-testing.
8
Autonomous
NBA (B.Pharm) &
FAT NAAC Accredited
Importance of Factory Acceptance Test (FAT) :
 FAT is beneficial for the manufacturer, buyer, and the endpoint user.
 It is the very cost effective way to fix the errors in the machine. FAT also establish
the point where the error (site of error) in the equipment was done.
 It helps manufacturer to keep his project running within budget.
 It is good to rectify all the issues with the machine at the manufacturer site than at
the owner site.
 And the most important is that safety of your employees is your top most priority, a
faulty equipment may cause loss to the buyer as well as manufacturer.
FAT is important for equipment because it helps to identify the problems with the
equipment and correct them prior to shipping. The equipment has to undergo what is
called FAT, so as to ensure its proven quality and compliance as these tests play a
vital role in ensuring guaranteed quality product.
9
Autonomous
NBA (B.Pharm) &
FAT NAAC Accredited
Delivery of the performed FAT protocol and documentation package

including:
 Performed FAT Protocol
 Maintenance and User’s manual
 Recommended spare parts list
 Certificate of compliance
 As built technical drawings (electrical, mechanical, pneumatic &
process schemes)
 Materials certificates/data sheets
 Main equipments data sheets
 Instruments calibration certificates
 Welding Processes qualification
10
Autonomous
NBA (B.Pharm) &
NAAC Accredited
SITE ACCEPTANCE TEST (SAT):
 SAT is Site Acceptance Test of a system to ensure it is tested in

accordance to client approved test plans and specifications and to show
the system is installed properly and interfaces with other systems and
peripherals in its working environment.
Summary - Inspection and /or dynamic testing of the systems or major system
components to support the qualification of an equipment system conducted and
documented at the manufacturing site.
The SAT is related to the FAT and also entails inspection and dynamic testing of
systems or major system components to support the qualification of equipment.
This is written by the client and verifies that the installed functionality of the
equipment meets or exceeds the operational requirements as specified in the
equipment URS.
The SAT is executed on completion of all commissioning tasks; but prior to the
start of Installation Qualification execution.
11
Autonomous
NBA (B.Pharm) &
SAT NAAC Accredited
• Site acceptance test is an useful tool to determine the functionality of the equipment at
the user site before its installation.
• Site Acceptance Test can determine whether or not systems are meeting the desired
and required specifications.
• The main purpose of SAT is to give an overall evaluation of a system's compliance and
to ensure this compliance meets the requirements of the business involved.
• Site acceptance testing also as a criteria testing for optimum results of systems.
• The SAT (site acceptance tests) are written by the client themselves and this verifies the
functionality of the equipment being tested.
• They are a as their title suggests, tested on site.
• The test will show whether the equipment meets, does not meet, or exceeds the
expectation of performance.
12
Autonomous
NBA (B.Pharm) &
SAT NAAC Accredited
 SAT documents need to be completed routinely in order for systems to meet GMP
requirements.
 Essentially SAT ensure all controlling and manufacturing of medicinal product meet the
standards of confidence of the legislation agreements expect them to take.
 The SAT is a test of not only efficiency but quality. By conducting an SAT, quality
assurance is met, along with good manufacturing practice, safe quality risk management
and a efficient quality control checks.
All results from SAT need to be monitored and recorded before being resourced
with the appropriate personnel.
 There are various elements of a Site Acceptance Test that will be included in the
test to ensure its success.
These include: Finishing visual checks, main components visual checks, internal box
pressure and ventilation setting checks, the functionality utilities to be checked, the interlocks
to be checked in relation to functionality, a hot test for dispensing systems, calibrator
verifications, safe devices checks and tests of the operator’s training and ability etc.,.
13
Autonomous
NBA (B.Pharm) &
SAT NAAC Accredited
Importance of SAT:
 Site acceptance tests are of huge importance as they allow for a system to prove it
is up to the job and can achieve its goals safely. Which in turn makes the user safe.
 FAT’s ensure the manufacturer is also safe, so the use of both acceptance tests is
absolutely necessary. Issues can be rectified before they have the potential to cause
damage or harm, which also allows for projects to be kept on track and, if applicable on
budget.
 Site acceptance tests aren’t just used in the pharmaceutical fields. They stem across all
borders of engineering, even into traffic sig equipment! By conducting an SAT all users
are able to acknowledge a system is doing its job right.
At its most basic level, a site acceptance test is the procedure of testing particular
equipment, systems or processes to ensure they are up to date with their internal
services and that they function to the required limits to keep everyone safe.
14
Autonomous
NBA (B.Pharm) &
SAT NAAC Accredited
The SAT (site acceptance test) will include the following tests:
1. Finishing Visual check
2. Main components visual check
3. Internal box pressure and ventilation setting
4. Utilities functionality and setting check
5. Functionality/Interlocks Verification (Mechanical & Software)
6. Hot test for dispensing systems (activity source supplied by Customer)
7. Dose calibrator verification (activity source supplied by Customer)
8. Safety devices and interlocks check
9. Operator’s training
15
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Qualification of Instruments
 Qualification of instruments is not a single, continuous process but instead
results from many discrete activities. For convenience, these activities have been
grouped into 4 phases of qualification.
 These phases are described below:
1. Design Qualification (DQ)

2. Installation Qualification (IQ)
3. Operational Qualification (OQ)
4. Performance Qualification (PQ)
5. Re-Qualification
16
Autonomous
NBA (B.Pharm) &
NAAC Accredited
1. Design Qualification (DQ):

 It is the documented verification that the proposed design of the facilities, systems
and equipment is suitable for the intended purpose.
 DQ should be performed when new equipment is being purchased, or when existing

equipment is being used for a new application.
 DQ serves as the precursor to defining the equipment Installation Qualification (IQ)

and OQ protocols.
 The purpose is to ensure that all the requirements for the final systems have been clearly
defined at the start.
In other words, “Has it been designed and selected correctly ?”
17
Autonomous
NBA (B.Pharm) &
NAAC Accredited
DQ Check Items:
 GMPs and regulatory requirements

 Performance criteria
 Reliability and efficiency
 Commissioning requirements
 Construct ability and installation of equipment
 Safety and environment impact
 Description of the intended use of the equipment
 Preliminary selection of the supplier
 Final selection of the equipment
18
Autonomous
NBA (B.Pharm) &
NAAC Accredited
2. Installation Qualification (IQ):
 It is documented evidence that the premises, supporting utilities, the equipment have
been built and installed in compliance with design specifications
 It verifies that the equipment has been installed in accordance with manufacturers
recommendation in a proper manner and placed in an environment suitable for its
intended purpose.
 It involves the co-ordinate efforts of the vendor, the operating department and the
project team.
 The purpose of IQ is to check the installation site/environment, confirms equipment

specifications and verifies the condition of installed equipment; and also to ensure
that all aspects (static attributes) of the facility or equipment are installed correctly
and comply with the original design.
In other words, “Has it been built or installed correctly ?”
 In IQ, connect each unit (Electrical system, Flow line system) and confirm that
the connections are correct.
19
Autonomous
NBA (B.Pharm) &
NAAC Accredited
IQ Check Items:
 Equipment design features (i.e. material of construction cleanability, etc.)
 Installation conditions (wiring, utility, functionality, etc.)
 Calibration, preventative maintenance, cleaning schedules.

 Safety features
 Supplier documentation, prints, drawings and manuals.
 Software documented
 Spare parts list
 Environmental conditions (such as clean room requirements, temperature, and

humidity)
 Any problems identified in IQ must be investigated and appropriate actions
must be taken. All such actions must be documented and approved by higher
authority.
20
Autonomous
NBA (B.Pharm) &
NAAC Accredited
3. Operational Qualification (OQ):
 It refers to establishing by objective evidence process control limits and action

levels which result in product that all predetermined requirements.
 OQ is the process of demonstrating that an instrument will function according to its

operational specification in the selected environment.
 The purpose is to ensure that all the dynamic attributes comply with the original
design.
 In other words, “Does it work correctly? ”
 Prior to implementing OQ, check the system configuration, determine the items to be
evaluated and record them in OQ record and have them approved.
21
Autonomous
NBA (B.Pharm) &
NAAC Accredited
OQ Check Items:
 Process control limits (time, temperature, pressure, line speed, setup conditions, etc.)
 Software parameters.
 Raw material specifications
 Process operating procedures
 Material handling requirements
 Process change control
 Training
 Potential failure modes, action levels and worst-case conditions

 The use of statistically valid techniques such as screening experiments to
optimize the process can be used during this phase.
Any problems identified in OQ must be investigated and appropriate actions must be

taken. All such actions must be documented and approved by higher authority
22
Autonomous
NBA (B.Pharm) &
NAAC Accredited
4. Performance Qualification (PQ):
 After the IQ and OQ have been performed, the instrument’s continued suitability for
its intended use is proved through performance qualification.
 It refers to establishing by objective evidence that the process, under anticipated

conditions, consistently produces a product which meets all predetermined
requirements.
 PQ should always be performed under conditions that are similar to routine sample
analysis. PQ should be performed on a daily basis or whenever the equipment is being
used.
PQ considerations include:
 Actual product and process parameters and procedures established in OQ.
 Acceptability of the product.
 Assurance of process capability as established in OQ.
 Process repeatability, long term process stability.
23
Autonomous
NBA (B.Pharm) &
NAAC Accredited
The objective is to ensure that the instrument is performing within specified limits. The
PQ represents the final qualification of equipment or system.
It is used to establish and /or confirm:
1. Definition of performance criteria and test procedures.

2. Selection of critical parameters, with predefined specifications.
3. Determination of the test intervals, e.g.,
a) Every day
b) Every time the system is used
c) Before, between and after a series of runs
4. Define corrective actions on what to do if the system does not meet the
established criteria.
24
Autonomous
NBA (B.Pharm) &
NAAC Accredited
5. Re-Qualification:
 Modification to, or relocation of equipment should follow satisfactory review and

authorization of the documented change proposal through the change control
procedure. This formal review should include consideration of re-qualification of
the equipment.
 Minor changes or changes having no direct impact on final or in-process product

quality should be handled through the documentation system of the preventive
maintenance program.
 Re-Qualification should be performed at least annually and should be performed

more frequently for applications whose test results have critical implications.
25
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Scope of Performance Qualification
• According to regulatory documents, like FDA guidelines, the scope of PQ is
somewhat limited. While equipment validation tests the ability individually for
each piece of equipment, PQ verifies the performance of equipment, systems and
facilities as a whole.
• It represents the final qualification, including any requalification of the system and
equipment that you use in your business.
 Typically, the scope of PQ extends to include the following scenarios:

 New systems being delivered and operated for the first time
 Existing systems in use (as part of a regular maintenance schedule)
 Systems that have been modified to any degree
 Equipment/systems which have been used more than they normally would be
 After a system has been expanded in order to increase its capacity
26
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Frequency of Performing Performance Qualification
• The objective of PQ is to provide quality assurance that the system is capable

of being subsequently validated. GMP and other such guidelines might not
specify the frequency of performing PQ, so the schedule or frequency you
choose depends on a lot of factors.
• This will typically be one or more of the following:

 Everyday
 Each time the equipment or system is used
 Before, after, or even during, a series of operations
 Other periodic schedule, or as needed
27
Autonomous
NBA (B.Pharm) &
NAAC Accredited
CALIBRATION AND PREVENTIVE MAINTENANCE
Introduction
• Regulations of the regulatory authorities like FDA and EU require that all the
firms have program for calibration and preventive maintenance for test as well as
measurement equipment.
• Preventive maintenance program is one of the most importance aspects for GMP
inspection as it ensures the efficient GMP operations.
• Any equipments either it is automatic or manually operated will perform its
functions properly and are used for manufacturing, processing, packaging, labeling
or holding of drug products; it is mandatory that it will be timely calibrated,
inspected and checked for errors according to the written program which is
specially designed to assure the best performance of the equipments.
28
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Definition of Maintenance: “Actions necessary for retaining or restoring a piece of

equipment, machine, or system to the specified operable condition to achieve its maximum
useful life.”
Types of Maintenance:
1. Preventive Maintenance
2. Predictive Maintenance
3. Breakdown Maintenance
29
Autonomous
NBA (B.Pharm) &
NAAC Accredited
1. Preventive Maintenance
"It is a care or service provided by personnel to maintain the equipment or facility in
satisfactorily working conditions by providing inspections, detection and correction of
failures before they occur. Basically they are conducted to keep the instrument in working
conditions and to extend the life of the instrument.”
Advantages of Preventive Maintenance:
1. Improvement in the reliability of system.
2. Decrease in replacement cost and productive time of the equipment / process.
3. Inventory management system is also improved.
4. Enhances the efficiency of equipment keeping them running more efficiently also impact
on less electrical power expenses.
5. Enhances the performance of equipment’s by increasing uptime.
6. Extends the useful lifecycle of equipment’s decreasing the need for capital
replacements (i.e., spares inventory)
7. It saves labor intensive and time.
8. Reduces cost of replacement.
 Preventive maintenance is performed while the equipment is still working, so

that it does not break down unexpectedly. ( Or ) It is also known as “Periodic
Maintenance”.
30
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Software used for Calibration and PM
Lots of software are used for calibration and PM at industrial scale. This computerized
system has more efficiency and guaranteed the best results.
Calibration software
• Quality Calibration Management system (QCMS) is complete instrument and

designed according to the requirements of 21 CFR part 11.
• This software ensures regulatory compliance and also traceability.
• It will help to improve the reliability of plant and optimize the administrative
costs. It will help to increase in the productivity as well as efficiency.
31
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Preventive maintenance software
• RCM turbo is very popular PM software. Traditional approach took years to

complete just one PM but by using this RCM turbo, anyone can quickly go for
PM. This software directs us through EMEA process. But the thing is it will go
through quickly and efficiently. It is 100 % reliable and will allow you do risk
assessment.
Why we perform the PM:
1. To avoid breakdown time of equipment

2. To avoid delay in process time
3. To Keep equipment in healthy condition
4. To avoid the spares cost as compare to breakdown of machine
5. It is an schedule based and it’s a cGMP practice.
32
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Typical responsibilities of Engineering maintenance:

1. Assure optimization of the maintenance organization structure.
2. Analysis of repetitive equipment failures.
3. Estimation of maintenance costs and evaluation of alternatives.
4. Forecasting of spare parts.
5. Assessing required skills required for maintenance personnel.
6. Ensures that equipment is performing effectively and efficiently.
2. Predictive Maintenance:
It is the techniques, are designed to help determine the condition of in-service
equipment in order to predict when maintenance should be performed.
3. Breakdown Maintenance:
Repairs or replacements performed after a machine has failed to return to its

functional state following a malfunction or shutdown it includes repairs,
replacements of spares or even overhaul to ensure the machine is put back
in operating condition.
33
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Calibration
Definition of Calibration: "It is a set of operation that performs under specific
conditions to verify the values/data obtained by comparison of two instruments or
measuring devices one of which is a standard of known accuracy (Traceable to
national standards). It is used to detect, correlate, report or eliminate any of the
discrepancy in accuracy of instruments or measuring devices when being compared
to the standard."
• Calibration is one type of comparison but it is not an adjustments.
Requirements of Regulatory Authorities:
 Calibration program is required by the regulatory authority (FDA) under section 21 CFR
part 211.68 and Preventive maintenance and calibration program is required by FDA
under section 21 CFR part 211.67.
 Calibration requirements for Lab instruments under section 21 CFR part 211.67 are:
specific directions, schedule, limit of accuracy and precision remedial action and system
to prevent usage of instrument which are failed to calibrate.
34
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Calibration and maintenance procedure (SOP)

 There should be a documented SOP for conducting the calibration and preventive
maintenance for each type of instrumentation.
 The SOP for calibration must includes accuracy and precision limits and what are the
remedial actions should be taken if this limits do not meet with each other. There should be
an authorized department to perform and monitor calibration and maintenance.
 The SOP must contain the step by step calibration instructions, instrumentation manual,
proper calibration procedures, provisions for adjustments, provisions for record and
document the actual measurement reading before and after doing adjustment.
Why calibration required:
1. A new instrument
2. After an instrument has been repaired or modified
3. When a specified time period has elapsed
4. When a specified usage (operating hours) has elapsed
35
Autonomous
NBA (B.Pharm) &
NAAC Accredited
Measure the pan position error of the balance (Daily calibration)

■ The maximum and minimum weight limits of the balance are taken and divided into four
to five parts and single standard weight is selected in those four or five different regions for
the purpose of daily calibration.
■ The variation allowed from the standard weight used for measuring is NMT ±0.1% of
standard weight.
■ Drift check from day to day is carried out using any particular weight and the deviation
allowed should not be more than ±1% of that weight.
Monthly calibration
• All the standard weights in the maximum and minimum weighing limits are used in
monthly calibration and the deviation allowed should not be more than ±0.1% of standard
weight used. (The standard weights that are used are E1 and E2 weights).
36
Autonomous
NBA (B.Pharm) &
Measurement of uncertainty NAAC Accredited
• For measurement of uncertainty any single standard weight is taken and is weighed for
10 times the readings are noted and the standard deviation for all the readings is calculated.
And measurement of uncertainty can be measured using the formula:
S. D. x 3
• Measurement of uncertainty = --------------------------
Standard weight taken
37

DR - ASR - Unit IB - Ph. Validation, 24-10-2019

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

DR - ASR - Unit IB - Ph. Validation, 24-10-2019

Uploaded by

Copyright:

Available Formats

Shri Vishnu College of Pharmacy

• This focuses on the ‘‘what’’ rather than the ‘‘how.’’

A well-written URS provides several specific benefits, as it:

What is Acceptance Testing?

 Completed during a FAT and a SAT

Summary - It is the partial commissioning and qualification of equipment and/or

 It helps manufacturer to keep his project running within budget.

Delivery of the performed FAT protocol and documentation package

 SAT is Site Acceptance Test of a system to ensure it is tested in

• They are a as their title suggests, tested on site.

1. Finishing Visual check

2. Main components visual check

3. Internal box pressure and ventilation setting

4. Utilities functionality and setting check

5. Functionality/Interlocks Verification (Mechanical & Software)

6. Hot test for dispensing systems (activity source supplied by Customer)

7. Dose calibrator verification (activity source supplied by Customer)

8. Safety devices and interlocks check

1. Design Qualification (DQ)

1. Design Qualification (DQ):

 DQ should be performed when new equipment is being purchased, or when existing

 DQ serves as the precursor to defining the equipment Installation Qualification (IQ)

In other words, “Has it been designed and selected correctly ?”

 GMPs and regulatory requirements

 The purpose of IQ is to check the installation site/environment, confirms equipment

In other words, “Has it been built or installed correctly ?”

 Installation conditions (wiring, utility, functionality, etc.)

 Calibration, preventative maintenance, cleaning schedules.

 Spare parts list

 Environmental conditions (such as clean room requirements, temperature, and

 It refers to establishing by objective evidence process control limits and action

 OQ is the process of demonstrating that an instrument will function according to its

 In other words, “Does it work correctly? ”

 Potential failure modes, action levels and worst-case conditions

Any problems identified in OQ must be investigated and appropriate actions must be

 It refers to establishing by objective evidence that the process, under anticipated

It is used to establish and /or confirm:

1. Definition of performance criteria and test procedures.

 Modification to, or relocation of equipment should follow satisfactory review and

 Minor changes or changes having no direct impact on final or in-process product

 Re-Qualification should be performed at least annually and should be performed

 Typically, the scope of PQ extends to include the following scenarios:

• The objective of PQ is to provide quality assurance that the system is capable

• This will typically be one or more of the following:

Definition of Maintenance: “Actions necessary for retaining or restoring a piece of

 Preventive maintenance is performed while the equipment is still working, so

Software used for Calibration and PM

• Quality Calibration Management system (QCMS) is complete instrument and

• This software ensures regulatory compliance and also traceability.

Preventive maintenance software

• RCM turbo is very popular PM software. Traditional approach took years to

1. To avoid breakdown time of equipment

Typical responsibilities of Engineering maintenance:

Repairs or replacements performed after a machine has failed to return to its

Requirements of Regulatory Authorities:

Calibration and maintenance procedure (SOP)

Measure the pan position error of the balance (Daily calibration)

You might also like