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
Validation Master Plan
A Seminar as a part of curricular requirement
for I year M.Pharm II Semester
Presented by
G.HIMABINDU (Reg.no:20L81S0703)
Pharmaceutical analysis
Under the guidance of
Dr. P.Ramalingam M.Pharm, Ph.D.
Director – R&D Division,
Professor of pharmaceutical analysis and medical chemisry
President – IPA local branch - anantapuramu

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
• Validation
• Validation master plan
• Who perform the validation master plan
• Contents of validation master plan
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
Validation
• Validation is an essential part of Good manufacturing
practices(GMP).
• It is therefore, an element of quality assurance programme
associated with particular product or process.
• The basic principles of quality assurance have as their goal the
production of products that are fit for their intended use.

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
• Quality, safety, efficacy must be designed and can be built in to the
product.
• Quality cannot be inspected or tested in to the product.
• Each critical step of manufacturing process must be validated.
• The concept of validation was first proposed by two Food and drug
administration officials.
• Tedbyers and Bud loftus, in 1979 in USA to improve the quality
of pharmaceuticals.
Principles as follows:

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
US-FDA :
Confirmation by examination and Provision of objective evidence that
the particular requirement for a specific intended use can be
consistently fulfilled.
WHO:
Validation is defined as the documented evidence that provides high
degree assurance that specific method or process or systems will
consistently produce results meeting the predetermined acceptance
criteria.
Definitions

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
Schedule M
• The defined process, materials and equipment specified shall be
demonstrated yield a product consistently of the required quality.
US FDA included Some form of validation around 1970s (process
validation under 21 CFR Parts 210 and 211).

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
Definition:
• The VMP is a high-level document that establishes an umbrella
validation plan for the entire project and summarizes the
manufacturer’s overall philosophy and approach, to be used for
establishing performance adequacy.
• It provides information on the manufacturer’s validation work
programme and defines details of and time scales for the validation
work to be performed, including a statement of the responsibilities
of those implementing the plan.
Validation Master Plan

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
VMP

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
Key elements:
• A validation policy
• Organizational structure of validation activities
• Summary of facilities, systems, equipment, process validated and
to be validated.
• Documentation format (e.g. Protocol and report format)
• Planning and scheduling
• Change control
• References to existing documents.

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
Who perform the VMP?
Members:
• Validation manager,
• Quality Assurance department
• Member from production
• Member from Engineering (utilities)
• Member from QC lab
• Member from HVAC department
• Member from product development lab

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
V
M
O
D
E
L

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
• Introduction
• Methodology
• Qualification:
 Design qualification (DQ)
 Installation qualification (IQ)
 Operational qualification (OQ)
 Performance qualification (PQ)
• Personnel
• Schedule
• Preventive maintenance
• Change control
• Documentation
Contents of VMP:

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 introduction of a VMP should include following details:
• A description of facility, its premises and equipment, and its purpose.
• Intension and scope of validation.
• Other relevant site policies and plans, like factory or corporate policy
statements on GMP, QA, etc.,
Introduction:

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

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
• The VMP document serves as a guide with company’s
overall approach towards performing validation and
qualification activities, in accordance with:
 WHO
 cGMP
 cGLP
Objective:

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
Validation master plan ensures that:
• To demonstrate that the facility is capable of meeting process or
product parameters in repeatable manner.
• The critical programs for utilities, qualification, process
validation have been established, in accordance with the product
requirements.

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
• This section should address the predetermined requirements by
identifying the standards that are applied to the facility.
• It also involves planning and execution of documents such as,
protocols, records, or other.
• The standards will involve three elements:
• Regulatory and guidance documents
• National standards
• Company standards.
Methodology:

18. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18
• This section encompasses all aspects of the design, procurement,
installation, and commissioning process.
• The extent of qualification and re-qualification shall be decided
based on critical nature of equipment and system.
Qualification:

19. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 19
• The very first part of the validation of any new equipment
Site, system or facilities could be the design qualification.
• It comprises the documented verification of equipment and
manufacturing facilities.
Design Qualification:

20. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 20
• The objective of this qualification is to establish evidence
that all key factors of the process equipment.
• It should be coherent to the manufacturers approved specification
along with recommendation of supplier of the equipment.
Installation Qualification:

21. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 21
• The objective of this qualification is to establish the evidence that
process control limits and action levels as per predetermined
requirements.
Operational Qualification:

22. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 22
• The objective of this qualification is to establish evidence that the
process, under anticipated conditions, consistently meets the
specified requirements.
Performance Qualification:

23. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 23
• The CFR 21 states that each person engaged in and
each person responsible for supervising the manufacturing,
processing and holding a drug product.
• All employees shall be trained on good manufacturing practices
(GMP).
• Training evaluation should be carried out with proper training
records as per standard operating procedures.
• The training includes validation activities and calibration as per
international regulations.
Personnel:

24. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 24
• The work programme is essential and should be prepared at an early
stage.
• A good plan will contain all necessary features which are to be
considered during execution of a plan.
• It ensures that all the personnel involved in the VMP are not only
aware of engineering targets but also the validation targets.
Schedule:

25. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 25
• This is the responsibility of site maintenance and operation
department.
• It embodies all maintenance and support activities necessary to
ensure the validated status of the systems.
• For standard procedure refer SOP for preventive maintenance of
equipments.
• Part of review process must conclude and examination of any change
recording.
Preventive maintenance:

26. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 26
• A strict change control procedure should be followed as per the
standard procedure.
• All changes shall be formally requested, documented and accepted by
the representatives of quality assurance.
• Change control format comprises of the following:
 Detail of change requested
 Reason for proposed change
 Impact and risk assessment of change.
Change control:

27. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 27
• Some of the major and minor changes are:
Major changes: For a substance of microbiological and chemical
quality evaluation.
• Addition or deletion of step in manufacturing process.
• Change in quality of raw materials used in formulation
manufacturing process.
• Change in input quantities of formulation manufacturing process.

28. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 28
• Minor changes:
Change in references( name/company name/address)
of manufacturing site.
• Change or updating the method of analysis used to test the substance.
• Change in supplier of starting and packaging material.
• Change in batch size.

29. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 29
• Each change control contains 7 digits.
CC-001/18
• First 2 digits represent change control code (CC).
• 3,4,5 digits represent sequential change control number (001).
• 6,7 digits represent the current year (18).

30. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 30
• For effective use of documents they should be designed and prepared
with utmost care.
• As per SOP it shall:
• Have a clear title
• Have a particular identification number
• Have the effective date
• Be approved by authorized persons.
Documentation:

31. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 31
• In case of any additional information added to the existing protocol
addendum or supplement should be prepared.
• Supplement or addendum shall be retained along with the existing
protocol.

32. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 32
• U.S. Food and drug administration, 21CFR 601.12 (a), April 1, 2000.
• International pharmacopoeia.
• Pandey m.a.g. Validation technology in pharmaceutical industry. A
Review Journal of drug discovery and development -2018,2(1),
(30-34).
• B.t. Loftus and nash, pharmaceutical process validation, drugs and
pharmaceutical sciences, vol-129, 3 edition, 2003 pg no. 144-155.
References

33. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 33