In this slide contains SITE ACCEPTANCE TEST IN QUALIFICATION. Presented by: K. SANDHYA RANI (Department of pharmaceutical analysis ).RIPER, anantapur

1. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
Presented by
Ms. K. Sandhya Rani
(Reg.No:20L81S0702)
Pharmaceutical Analysis
A Seminar as a part of curricular requirement for 1st year
M. Pharm 2nd semester

2. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
 Introduction
 Objective
 X - Model
 Process
 References
Contents:

3. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3
 Site acceptance test is the process of inspection with documentation of the
equipment at the user site for any change, damage, wear and tear during
the transportation and shipping.
 It determine whether or not systems are meeting the desired and required
specifications.
 It is an useful tool to determine the functionality of the equipment at the
user site before it’s installation.
Introduction:

4. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4
 To give an overall evaluation of a system's compliance and to ensure this
compliance meets the requirements of the business involved.
 By conducting SAT, quality assurance is met, along with good
manufacturing practice, safe quality risk management and efficient
quality control checks.
 All results from SAT need to be monitored and recorded before being
resourced with the appropriate personnel.
Objective:

5. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5
 The SAT is a test of not only efficiency but quality. It is up to senior
management and committed staff to keep a track of system software levels
across different departments.
 Once the equipment has been delivered to the user site, it will be received
by the user as per SOP of receipt of machines and equipments.
 The SAT also has to transfer across premises, facilities and equipment so
need to be a test that can be conducted across the borders.

6. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 6
 There are various elements 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 of utilities to be checked, the interlocks to be checked in
relation to functionality,
• A hot test for dispensing systems, Calibrator verifications, Safety devices
checks and tests of the operator's training and ability.

7. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7
X - Model for SAT

8. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8
Manufacturer will sent engineer for installation of equipment at the user
site.
Equipment will be removed out from the packaging, then machine will be
inspected for any damage during shipment and transport and handling.
Check the spare parts, tools and other utilities as per packing list and record
the observation.
Process:

9. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9
Also check the documents such as manuals and excise and transport
documents. Hand over the documents to the concern department.
Carry out the sanitation and cleaning of machine as per SOP before
transferring it to the concerned department clean atmosphere.
After sanitation wrap the equipment with film or poly ethylene paper and
then transfer it to the intended location.

10. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10
Install the equipment properly and connect the utilities and service lines
such as water, air, vaccum to the machine/equipment.
Area qualification shall be completed prior to the installation of equipment
in new facility.
SAT protocol will be prepared by the equipment manufacturer and it will be
reviewed by both manufacturer and user before implementation.

11. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11
 Both the critical and non critical parameters and functions shall be
challenged during SAT.
 Records the observation and results in SAT protocols, if machine complies
SAT specifications and acceptance criteria.
 Review and approve the SAT protocol and report after completion of
documentation, equipment is recommended for IQ.
 Site acceptance tests are related to factory acceptance tests, in that they
work by inspection and dynamic forms of testing to system components.

12. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12
 SAT (site acceptance tests) are written by the client themselves and this
verifies the functionality of the equipment being tested.
 Site acceptance tests are of huge importance as they allow for a system to
prove that it is up to the job and can achieve it’s goals safely.
 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.
 Site acceptance test documents need to be completed routinely for systems
in order to meet GMP requirements.

13. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 13
The following documents are needed for the SAT:
• Process control description
• Instrument Specifications
• System I/O list, datasheets,
• Instrument calibration certificates
• Recommended spares list
• Logic flow diagrams
SAT Documents:

14. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 14
• Process P&ID
• Termination lists
• Communication interfaces, Program listings
• Manufacturer manuals, drawings
• Startup procedures, Punch points list
• The SAT typically consists of follow-up, discussions, and validation of
the system functions.

15. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 15
Problem Solution
The plant is not ready (building, rooms,
utilities), no real product, missing approvals.
Time scheduling and progress supervision
in all areas. If necessary delay delivery.
Staff (operators, maintenance) not
sufficiently trained or not enough personnel
available to support trials.
Early recruiting and planning in of
resources.
Test fails because site specific conditions
were not considered in planning.
Thorough check of URS with regard of site
specific conditions.
Equipment has been damaged during
transport or parts are missing.
Choose reliable freight forwarder, correct
packing + protection. Check transport ways
before start of delivery.
Equipment has been installed incorrectly. Choose qualified installation company.
Preferably involve vendor of equipment.
Common problems in SATs and how to avoid them:

16. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16
References:
1. P.P. Sharma, Validation in pharmaceutical industry concepts, approaches
and guidelines, 1st edition; 2007.
2. M.d Shoaib Alam, Pharmaceutical process validation: An overview,
Journal of pharmacy education and research, : Vol 2; issue 4, 2012.
3. Robert A. Nash, Alfred H. Wachter, Pharmaceutical process validation,
3rd edition, Vol 129; 2003.
4. Manohar A. Potdar, Nirali Prakashan, Pharmaceutical Quality
Assurance, CBS publishers, 8.1- 8.22; 2010.
5. Agallaco J.A, Carleton F.A, Validation of Pharmaceutical Process, 3rd
edition, 2005.

17. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 17