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SPEAKERS
Eminent personalities from academia, regulatory and
highly experienced personnel from pharmaceutical
industry shall deliver the lectures. A panel discussion
on queries from participants shall also be held.
REGISTRATION FEE
Rs 3000 /- per delegate, Rs 2000/- for members
registered with SMPIC, NIPER and Rs 800/- for students.
The fee includes course material in the form of CD,
lunch, refreshments, tea /coffee and excludes
accommodation charges.
About SMPIC
SMALL AND MEDIUM
PHARMACEUTICAL INDUSTRY CENTRE
Department of Pharmaceuticals, Government of India,
announced the setting up of a dedicated centre for Small
and Medium Pharmaceutical Industries (SMPIs) at
Pharmaceutical Advisory Forum (PAF) on 23rd April 2008.
This Centre called as SMPIC, offers practical trainings on
analytical instruments and conducts seminars on issues of
Pr
ocess Valida
tion and Equipment
Process
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Qualif
ica
tion: A Risk Based Appr
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Qualifica
ication:
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relevance to the Pharma industry like GLP, GMP & regulatory
affairs. All these activities have been designed in consultation
with SMPIs. This dedicated centre aims at creating synergy
between industry and academia.
NIPER has successfully conducted 53 training programs
On-site Registration
The on-site registration desk will be open on the day
of seminar from 8.30 to 10.00 am.
An additional fee of Rs 500/- will be charged for onsite registration.
under the World Bank sponsored “Capacity Building Project”
in the years 2004 to 2008. These were meant for the
technical staff from government testing laboratories,
regulatory bodies, private testing laboratories and analytical
as well as production staff from SMPIs.
How to reach NIPER, S.A.S. Nagar (Mohali)
20th March, 2015
NIPER, S.A.S. Nagar (Mohali) is situated near Chandigarh,
that is well connected by air, rail and road. NIPER is about
18 km from Chandigarh Airport, 14 km from Chandigarh
Railways Station, 10 km from ISBT, Sector-17, Chandigarh
and 5 km from ISBT, Sector 43, Chandigarh.
National Institute of Pharmaceutical Education and
Research (NIPER)
Sector 67, Near PCA Stadium, S.A.S. Nagar - 160 062, Punjab
(Block G, Room no. 105)
Phone : 0172-2292032, Fax : 0172-2214692
Email : [email protected]
Equipment Qualification (EQ): Qualification of equipment is
TOPIC OF SEMINAR
an integral part of validation strategy. It provides documented
SEMINAR ON
evidence that the equipment has been installed as per
PROCESS VALIDATION
AND EQUIPMENT
QUALIFICATION : A RISK BASED APPROACH
specifications and will attain and maintain critical process
parameters repeatedly and reliably. EQ has 3 main components
like installation, operational and performance qualification. The
Process Validation and Equipment
Qualification: A Risk Based Approach
Process Validation: Validation involves establishing documented
state of EQ practices in the pharmaceutical industry is evolving
evidence demonstrating that a specific process will consistently
and is subject to much variation. EQ needs to be performed on
produce a product meeting its pre-determined specifications and
equipment used in laboratories and manufacturing. Through
quality attributes. By validating the process, applications and
risk assessment, impact of equipment on the quality of product
equipment, it is guaranteed that the pharmaceutical products meet
can be evaluated and the critical components of equipment/
quality demands and comply with regulations. The validation
system can be identified. This approach assures that the
Name Prof./Dr./Mr./Ms ...............................................
validation activities are performed in a structured and GMP
Designation ...............................................................
procedure involves a series of activities taking place over the lifecycle
of the product and process. A properly designed system will provide
compliant manner according to the current regulations.
20th March, 2015
SMALL AND MEDIUM PHARMACEUTICAL INDUSTRY CENTRE
National Institute of Pharmaceutical Education and Research (NIPER)
Sector-67, Near PCA Stadium, S.A.S. Nagar-160062. (Punjab)
Phone: 0172-2292032, Fax: 0172-2214692, email:[email protected]
Registration Form
Institute/Organization ................................................
a high degree of assurance that every step, process and change has
This seminar shall focus on validation risk assessment activities
been properly evaluated before its implementation.
of both process and equipment. Different stages of process
Over the recent past, pharmaceutical companies have begun moving
validation like process design, Quality by design (QbD) and
Address .....................................................................
continued process verification along with equipment validation
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from the classic, validation strategy to a more targeted methodology
based on risk. The evaluation of different risks is assessed by
preparing a risk assessment chart through application of a process
shall be discussed. The seminar is intended for the personnel
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from the industry and researchers within the academic
community.
Mobile No. .................................................................
failure mode, effects and criticality analysis. A risk-based approach
to process validation helps to identify crucial control parameters that
The following are some of the topics that shall be deliberated in
E-mail ........................................................................
the seminar:
Amount Paid for Registration ....................................
different risks on product quality.
1. Process Validation: A Risk based approach
DD No. & Date ..........................................................
US FDA also encourages the use of modern pharmaceutical
2. QbD in manufacturing of APIs
development concepts, quality risk management and quality systems
3. QbD in manufacturing of dosage forms
at all stages of the manufacturing process. A risk assessment must
4. Instrumentation and Validation: A risk based approach
be performed for all validations as it determines the validation
5. Aspects of Cleaning Validation
affect product quality and provides a consistent method for evaluating
REGISTRATION FEE
Delegates
Rs. 3000/-
SMPIC Members
Rs. 2000/-
*Students
Rs. 800/-
parameters of the overall equipment or system and the required
The last date for Registration is 16th March, 2015
functions.
An extra Rs. 500/- for on-site Registration
*Students are required to attach id Proof
DD in favour of Director, NIPER, Payable at Mohali should be
sent along with dully filled form.