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Document No.

ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

VALIDATION MASTER
PLAN

Alembic Limited
Plot No. 21& 22, EPIP Phase-I, Jharmajri,
Baddi, Distt.- Solan, H.P.

Page 1 of 25
Review Date
14.11.2007

Document No.
ALB/F/VMP/001-01

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN

Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

QUALITY ASSURANCE DEPARTMENT

Page 2 of 25
Review Date
14.11.2007

VALIDATION MASTER PLAN

APPROVAL
Activity
Prepared by

Name

Area Representative

A.K. Tumbariya

Sr. Executive-Q A

Reviewed by

Kailash Yadav

Engineering Head

Vijay Karwa

Process Development Lab

Yogesh Arya

Manager Quality Control

V Balaji

Quality Head

Devendra Vijay

Plant Head

Dr. Balwant Desai

VP - Quality & RA

Approved by

Signature / Date

Document No.
ALB/F/VMP/001-01

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN

Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

Page 3 of 25
Review Date
14.11.2007

QUALITY ASSURANCE DEPARTMENT

Table of Contents
Particulars

Page No.

1.0

Introduction

04

2.0

Validation Master Plan

3.0

2.1

Validation Policy

05

2.2

Scope of Validation

05

2.3

Validation Team

06

2.4

Documentation

07

2.5

Validation Process

09

2.6

Revalidation

11

Validation Approach
3.1

User Requirement Specifications

12

3.2

Functional Specification

13

3.3

Design Specification

13

3.4

Stage of Qualification

13

3.5

Basis of Acceptance

14

4.0

Analytical Method Validation

15

5.0

Cleaning Validation

17

6.0

Process Validation

18

7.0

Facility Qualification

19

8.0

Water System validation

20

9.0

HVAC system Validation

21

10.0

Compressed Air System Qualification

22

11.0

Computer system Validation

23

12.0

Validation Schedule

23

13.0

Supporting Programs

24

14.0

References

25

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

1.0

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 4 of 25
Review Date
14.11.2007

INTRODUCTION:
This document serves as the Validation roadmap, setting the course, justifying the strategy,
outlining the preliminary test and acceptance criteria, and documenting the necessary programs
that ensure a continuing state of validation.
Overview of the Plant:
Alembic limited (Formulation Division), Baddi is a multi-product, multi-purpose a solid oral
dosage form-Tablet & Capsule and liquid oral dosage form-Syrup and Suspensions
manufacturing facility located about 40 Kms. away from Chandigarh.

The basic features of the facility are as follows:

There are separate Granulation facilities aimed at multiple batch size requirement along
with separate compression and coating facility.

Integrated Hard Gelatin Capsule Filling Line.

Separate Primary packing line, for various types of primary packaging including foil, blister
packing.

All services, including Air handling system are created to access from area separated from
the operating area.

The material and personnel flow, pressure zoning, air filtration and dust extraction system
are designed matching with the requirement of multi product handling.

The plant has independent Quality control laboratory for routine Quality testing.

No cytotoxic, beta lactums, cephalosporin, hormones shall be manufactured in this facility.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

2.0

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 5 of 25
Review Date
14.11.2007

VALIDATION MASTER PLAN


2.1 Validation Policy:
Validation shall be used as a tool for providing a high degree of assurance that a specific
system, process, or facility will consistently produce a product meeting its predetermined
specifications and quality attributes.
The organization shall provide the necessary resources for organizing and executing the
validation activity.
In situation of multiple validation tasks, priority shall be decided based on the severity and
risk factor involved with those tasks-the Validation Plan shall be made accordingly.
Change control and revalidation criteria shall be established and implemented to identify,
document and review changes to all variables that could alter the validated state of each
manufacturing process.
Primary responsibility for execution of validation actives shall be Site quality head. The
Steering Committee for Validation shall periodically review Existing vs. Available Technology
and limitations of the Existing Technology. The Validation Master Plan shall be updated to
incorporate new changes.
2.2 Scope of Validation:
This VMP shall be applicable to all the Validation activities covering Manufacturing, Quality
Control, Quality Assurance and Engineering functions to be under taken at Alembic limited
(Formulation Division), Baddi.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 6 of 25
Review Date
14.11.2007

Following areas shall be covered under Qualification / validation:Qualification:

Facility Qualification, Critical Process equipment and lab instrument qualification and Utility
qualification (Water system, HVAC, Compressed air etc.)

Validation:

Analytical Methods

Manufacturing Processes

Cleaning Methods and Procedures

Computer Systems (MMI /PLC/PC etc.) wherever applicable.

Material inventory system (SAP) and BMS system.

2.3 Validation Team


Validation Steering Committee:
It shall comprise of:
1. Head - Quality
2. Head-Manufacturing
The steering committee shall nominate the Validation team as per the respective validation task:
Validation Team:
Validation Team shall be a dedicated group of person, whose principal task will be of Validation.
Corporate Quality Head shall be the Chairperson of validation team. The team shall be comprised
of one nominee from each of the following areas as per application:
1. Production Department
2. Quality Control Laboratory
3. Engineering Services
4. Quality Assurance
5. Process Development Lab.

Document No.
ALB/F/VMP/001-01

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN

Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

Page 7 of 25

QUALITY ASSURANCE DEPARTMENT

Review Date
14.11.2007

Members of this team shall be nominated in consultation with the respective department heads
and shall be approved by the steering committee. The team shall be responsible for identifying,
planning, organizing, and co-coordinating, monitoring and documenting validation exercise.
2.4 Documentation:
Once

the

Validation

Plan

is

made,

specific

Validation

tasks

shall

be

undertaken and documents shall be designed.


2.4.1 Types of Document:
The Validation documentation shall consist of:

Validation Protocol

Validation Report

Validation Protocol shall be a written plan stating how validation will be conducted, including test
parameters, product characteristics, production equipment and acceptance criteria. It shall also
describe the criteria for re-validation /re-qualification.
A validation protocol shall contain following information
Scope
Description of item or system to be validated or qualified.
Tests to be carried out
Responsibilities etc.
Validation Report shall scientifically evaluate the data collected during the validation exercise and
conclude vis--vis the validation protocol. It shall also record the conclusion of the validation
exercise and if required shall give the recommendation for certain modifications before a
revalidation is done.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 8 of 25
Review Date
14.11.2007

2.4.2 Change Control:


Change Control system shall provide a procedure by which any proposed or actual change into
system (either in software or hardware related aspects) - that might affect a validated status, shall
be reviewed. The intent is to determine the need for action that would ensure and document that
the system is maintained in a validated state.
2.4.3 Preparation, Review and Approval of Validation Documents:
All validation documents shall be prepared, reviewed and approved by authorized personnel of the
Validation Team to ensure their correctness and impact on the system as follows:
Quality assurance personnel, in consultation with respective line supervisor/manager who is
responsible for the implementation of the system, shall check the Validation Protocol and
Validation Report along with the Supporting Documents like Specification-Method of Analysis,
Certificate of Analysis.
Corporate Quality Engineering personnels provide basic template and guidelines for the
preparation of the documents.
The Members of Validation Team shall prepare & review the Validation protocol and Validation
Report. The Steering Committee members shall approve the Validation Protocol and Validation
Report.
2.4.4 Archival & Copies:
The Validation documents shall be archived by Quality Assurance Department as per the Standard
Operating procedure.

Document No.
ALB/F/VMP/001-01

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN

Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

QUALITY ASSURANCE DEPARTMENT

Page 9 of 25
Review Date
14.11.2007

2.5 Validation Process:


Prior to validation of any system all necessary Qualification of the components of the system shall
be completed and report shall be reviewed and approved by the Validation committee.
The Qualification of any Component of a system / equipment exercise includes:

User Requirement specification ( URS)

Design Qualification ( DQ)

Installation Qualification (IQ)

Operation Qualification.(OQ)

Performance Qualification ( PQ)

All measuring Instruments to be used during the Qualification and Validation exercise should be
calibrated to a traceable national or international standard.
The Validation exercise shall be done by adopting any of the following approach which ever is
suitable

Prospective basis,

Concurrent basis, or

Retrospective basis.

Prospective Validation:
It shall be performed before an entirely new product is introduced by the company, or when there is
a change in the manufacturing process, which may affect the product's characteristics, such as
uniformity and identity, etc.
Documentation: Prior to the validation exercise there shall be proper documentation of the Process
Optimization Batches and subsequent technology transfer. The data for the prospective validation
shall at least comprise of 3 sets of data that are consecutive and are a result of successfully
completed exercises. It is essential that the validation program is documented and that the
documentation is properly maintained. Approval and release of the process for use in routine

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 10 of 25
Review Date
14.11.2007

manufacturing should be based upon a review of all the validation documentation, including data
from the equipment qualification, process performance qualification, and product/package testing
to ensure compatibility with the process.
Concurrent Validation:
It shall be carried out during routine production of products intended for sale. Concurrent
validation shall be done when i. There is change in process or equipment for an existing product.
ii. The product is manufactured very infrequently.
iii. Established Products for which Validation has not been done prospectively.
Documentation: The data for the Concurrent validation shall at least comprise of 3 sets of data
that are consecutive and are a result of a completed exercise.
Retrospective Validation:
It shall be carried out for a product, which has been marketed based upon accumulated
manufacturing, testing and control test data. Retrospective validation shall be done wheni. The System has been stabilized and no changes are required for the system.
ii. The System components viz. Equipment, Utilities, Facilities are qualified as per the standard
norms.
iii. The interrelated systems such as Analytical Methods or Cleaning Methods or Processes are
validated.
Documentation: The data for the Retrospective validation shall at least comprise of 20 sets of
data that are consecutive with no change in the system either in Hardware aspect or Software
aspect and are a result of a completed exercise. If the product is not manufactured routinely then
minimum 10 sets of data can be considered only after authorization of Validation Team.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 11 of 25
Review Date
14.11.2007

2.6 Revalidation:
Facilities, systems, equipment and processes, including cleaning should be periodically evaluated
to confirm that they remain validated there is no significant changes have been made to the
validated status, a review with evidence that facilities, systems, equipment and process meet the
prescribed requirements fulfils the need for revalidation. Re-validation shall consider under
following consideration:

Change in critical component (active ingredients, excipients, or primary packaging).

Change or replacement in critical parts of the equipment, which may affect the quality of
the product.

Significant change in process conditions that may affect subsequent unit operations
and product quality.

Significant change in the batch size that affect the operation of the modular equipment.

Failure of sequential batches to meet product and process specifications.

The Critical, Major & Minor changes shall be classified as follows:


Critical: Critical changes are those changes that are likely to have a significant impact on
formulation, Quality and Performance.
Major: Major changes are those changes that could have a significant impact on formulation,
Quality and Performance.
Minor: Minor changes are those changes that are unlikely to have a significant impact on
formulation, Quality and Performance.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 12 of 25
Review Date
14.11.2007

3.0 VALIDATION APPROACH:


The approach for Validation shall based on the V Model as shown in diagram.

3.1 User Requirement Specification (URS) and Gap Analysis:


User Requirement Specification (URS)
URS, as a document, shall define the functional attributes and standard of facility or system. It
shall provide the basis for subsequent design and qualification. URS shall contain the following
information 1. Objective and scope
2. Process description, operational requirements , Basic machine /system details product
quality requirement and general cGMP requirement
3. Capacity / output requirements.
4. Process parameter outline.
5. Material of construction and surface finish requirement. where necessary.
6. Control system requirement.
7. Safety requirement & environmental conditions
8. Training of technical personnel by vendor.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 13 of 25
Review Date
14.11.2007

3.2 Functional Specification (FS):


The Functional specification (FS) shall document functions, standards and permitted tolerances
of the system (plant) or system components (equipment) and will define the operating capabilities
of the equipment.
3.3 Design Specification (DS):
Design specification (DS) shall define the design specifications of the system/system component
and shall detail the conscious decisions in the selection of the supplier.

3.4 Stages of Qualification:


Qualification shall cover the following areas:

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

3.4.1 Design Qualification:


Design Qualification (DQ) is documented verification that the proposed design of the facilities,
equipment, or systems is suitable for the intended purpose and to meet the cGMP requirements.
3.4.2 Installation Qualification:
Installation qualification (IQ) is documented verification that the facilities, systems and
equipment, as installed or modified, comply with the approved design or manufacturers
recommendations. Following activities shall be carried out during execution of IQ1. Installation of equipment, piping, services and instrumentation shall be checked as per
approved design and specification.
2.

Suppliers SOP or work Instructions and details of maintenance requirements shall be


collected and collated.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 14 of 25
Review Date
14.11.2007

3. Material of construction of all components shall be verified either by analysis or by


obtaining testing certificates from vendor issued by suitable agencies
4.

All attached instruments shall be checked for calibration status and calibration certificates
of those instruments shall be compiled.

3.4.3 Operational Qualification:


Operational Qualification (OQ) is documented verification that the equipment / systems or subsystem as installed or modified, perform as intended throughout all anticipated operating ranges.
OQ shall check that the installed systems in support of each other are in a state of readiness for
the intended operation and while use shall produce an end result as conceived at the stage of
designing. The system shall be checked for upper and lower operating limit. At least draft form of
the SOP for the equipment/system shall be made ready at this stage.
3.4.4. Performance Qualification:
Performance Qualification (PQ) is documented verification that the equipment and ancillary
systems, as connected together, can perform effectively and reproducibly as intended under
normal operating environment.
PQ shall be done using production material, qualified substitutes or simulated product and the
suitability of the system is established to give desired output when operated under specified
operating parameters. This may be carried out as a part of Process validation.
3.5 Basis of Acceptance:
3.5.1 Factory Acceptance Test:
The factory Acceptance Test (FAT) shall be conducted at the manufacturers site by a
multidisciplinary team (comprising of Quality, Production and Engineering personnel) during
different stages of assembly/fabrication the system to ensure the fitness of the entity for the
intended use. FAT exercise is basically a Pre-qualification.
The Stages of inspection would be decided at the time of releasing Purchase order.

Document No.
ALB/F/VMP/001-01

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN

Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

QUALITY ASSURANCE DEPARTMENT

Page 15 of 25
Review Date
14.11.2007

Following details shall be covered during FAT

User Requirement specification /Purchase order requirement.

Critical components (Contact parts) stamping and analysis.

Pre-finish inspection.

Final Inspection at vendor site

Approval by the inspection team.

P& ID verification.

GA Drawing verification.

Remarks: Factory Acceptance Test shall not be carried out if the equipment /system is of
standard make.
3.5.2 Site Acceptance Test:
The Site Acceptance Test (SAT) shall be conducted at the installation site before delivery of the
system / equipment by a multidisciplinary team to ensure that all the Pre-Installation Checks
( Utility / Area / Finishes etc. ) recommended by the vendor are satisfied.
4.0 ANALYTICAL METHOD VALIDATION
Analytical method validation is the process by which it shall be established, by laboratory studies,
that the performance characteristics of the method meet the requirements for the intended
analytical applications. Analytical Development Laboratory (ADL) located at Vadodara shall
perform this activity. It shall be performed in accordance to ICH requirements.
In case of compendial method, it shall check for method suitability. In case of any specific
regulatory recommendation total validation exercise shall be performed.
For non-compendial method, validation shall be performed for selected parameters depending
upon the type of product and analytical method (instrumental / non-instrumental /
microbiological). In case of new product, the developed method shall be checked for desired
validation parameters as per the protocol to ensure its robustness.

Document No.
ALB/F/VMP/001-01

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN

Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

Page 16 of 25
Review Date
14.11.2007

QUALITY ASSURANCE DEPARTMENT

The validation shall be carried out as per ICH guidelines. The details are given as under:
Type of analytical Identification

Testing for impurities

pr

Assay
-

Quantitation.

oc

Limit
-

Dissolution
( Measurement only )
Content / Potency

ed
ur
e
Characteristics
Accuracy
Precision
Repeatability
Intermediate
Precision
Specificity (2)
Detection limit
Quantitation limit
Linearity
Range

+
+(1)

+
+(1)

+
-

+
-(3)
+
+
+

+
+
-

+
+
+

- Signifies that this characteristic is normally not evaluated.


+ Signifies that this characteristic is normally evaluated.
(1) In case where reproducibility has been performed. Intermediate precision is not
needed.
(2) Lack of specificity of one analytical procedure could be compensated by other
Supporting analytical procedure.
(3) May be needed in some cases.
After the validation of Analytical method, it is transferred to respective site on the basis of their
requirement by the Personnel from Analytical Development Laboratory.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 17 of 25
Review Date
14.11.2007

Revalidation:
Revalidation may be necessary in the following circumstances:

Changes in critical raw materials

Changes in the Manufacturing Process /Formula.

Changes in the composition of the Finished Product.

Changes in the analytical procedure.

The degree of Revalidation required shall depend on the nature of the changes.
5.0 CLEANING VALIDATION:
Cleaning validation shall be carried out to establish documented evidence which shall produce a
high degree of assurance that the cleaning procedure adopted for cleaning of manufacturing and
processing equipments are adequate and reproducible to the acceptable level of previous product
or carryover of the residues.
Cleaning validation studies shall comprise of:
5.1 Selection of candidate for Product/Equipment Grouping:
5.2 Worst case selection on the basis of the following:
5.2.1

Solubility

5.2.2

Dosage ( Strength)

5.2.3

Batch Sizes

5.2.4

Difficulty to clean

5.2.5

High potent Drugs

5.3 Development of cleaning method for the prospective studies.


5.4 Sampling method and its recovery.
5.5 Analytical method validation.
5.6 Determination of MAC (Maximum Allowable carryover).
5.7 Cleaning validation report, summary and conclusion.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 18 of 25
Review Date
14.11.2007

Acceptance Criteria:
1. The equipment should be visually clean.
2. Not more than 0.1% of the minimum dose of the residue active in the maximum dose of the
next product.
3.

10 PPM Criteria.

Re-validation criteria:
Whenever there is change in the

Cleaning Methodology

An addition/deletion in the list of Equipment. introduction of new product in


the product group.

Formula/manufacturing process of any product in product group, which may


affect the status of Cleaning Validation.

6.0 PROCESS VALIDATION:


Process validation is establishing documented evidences, which provides a high degree of
assurance that a specific process shall consistently produce a product meeting its predetermined
specifications & quality characteristics. Process validation shall be carried out for the drug
products, which are being manufactured for the first time at the location. Process validation
protocol shall be based on the Master document of the product.
The validation studies shall be based upon the three consecutive batches of the product
manufactured by the same manufacturing process, under identical conditions and using one set or
equivalent of equipment, controlling the critical process parameters.
Three batches shall be tested for compliance to the pre-determined specification, which also
includes in-process sampling and testing.
Once the process gets validated, it has to be maintained to produce a product consistently to meet
the predetermined quality attributes.

Document No.
ALB/F/VMP/001-01

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN

Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

QUALITY ASSURANCE DEPARTMENT

Page 19 of 25
Review Date
14.11.2007

Re-validation Criteria: Re-validation is required, if


1. Change in Critical manufacturing equipment.
2. Change in manufacturing process.
3. Change in Batch size and Formula.
4. Change in Source of raw material. (Active and critical inactive material )
7.0 FACILITY QUALIFICATION:
Design qualification (DQ) should be carried out to finalize the facility according to
Predetermined design specification. Design Qualification is a validation task to ensure that all the
cGMP regulatory aspect have been covered in the design bases and the facility design are as per
intended use.
DQ shall be carried out to evaluate the facility according to predetermined design requirements.
Following points shall be covered in the Design Qualification 1. Rationale for design
2. Basis of design
3. Area specific design. (Manufacturing, Quality control, warehouse and Administration
block.)
4. Construction and finishes details like Floor, wall, ceiling, coving, window, doors etc.
5. Utility services.

Electrical

HVAC system

Water system

Compressed air.

6. Logistics and Administrative activity.


7. Personnel and material movement.
8. Site Acceptance test protocol.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 20 of 25
Review Date
14.11.2007

Design shall be such that it will take care all possible contaminants, as the facility is a multiproduct multipurpose.
8.0 WATER SYSTEM VALIDATION:
Water utilized in the manufacturing process and for final rinse of equipment shall comply with
Purified water of Pharmacopoeial grades as relevant as per the area of application. The approach
for qualification shall be as follows Design Qualification (DQ)
It provides documented evidence that the design of the system is suitable for the intended purpose
and is capable of producing purified water meeting all quality and cGMP requirements as defined
in user requirement specification.
Installation Qualification (IQ)
Documentation that the system is constructed according to the specific design in terms of static
attributes. All the individual components shall be checked during IQ as per approved design.
Operation Qualification (OQ)
Documentation that a system or sub-system performs as intended when compared to a
predetermined set of dynamic attributes. Dynamic attributes shall include conformance to
performance specifications such as water flow velocity, sanitization requirements, etc.
Performance Qualification (PQ)
Documentation that a system or sub-system performs as intended and meets all the User
Requirements. During PQ chemical and microbiological parameters of purified water shall be
analysed thoroughly in three phase.
3 Phase Approach for the PQ
The PQ shall take place in three phases. There shall be phases-I for 4 weeks, Phase-II for 4 weeks
and Phase-III for 10 month during this the water shall be monitored, chemically and

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 21 of 25
Review Date
14.11.2007

microbiologically. The 12 month period shall enable the performance of the system to be qualified
(taking seasonal variations into account).
Test Summary / Conclusion for the PQ
The summaries of the Chemical and microbial testing shall be completed for each phase of the PQ.
Once a phase is completed, a conclusion shall be written indicating whether the Chemical and
Micro specifications are complying with the pre-set criteria.
9.0 HVAC SYSTEM VALIDATION
Heating ventilation and air conditioning (HVAC) system are used to control the level of viable
and non- viable particulate exposure that a drug receives in addition to regulating temperature and
relative humidity conditions by maintaining required room pressure and air changes. The approach
for qualification shall be as followsDesign Qualification
Design Qualification is providing documented evidence that the design of the system is suitable for
the intended purpose. Parameters like filtration standard, airflow direction, air change rates, etc
shall be considered on cGMP point of view and for intended purpose to prepare the DQ document.
Installation Qualification (IQ)
All the individual components shall be checked during IQ as per approved design.
Operation Qualification (OQ)
OQ shall check that the installed system in support of each other is in state of readiness for the
intended operation and while use shall produce an end result as conceived at the stage of designing.
Following parameters shall be carried out during OQ Operational Procedure Compliance Test
Local Control Panel Operation Test
Temperature & RH monitoring

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 22 of 25
Review Date
14.11.2007

Differential Air pressure & direction Test.


Air Change Rate
DOP Test
Performance Qualification (PQ)
Documentation that a system or sub-system performs as intended and meets all the User
Requirements. The PQ shall include the following topics:
Non-viable Particulate count
Viable Particulate count
Summary & Conclusion
10.0 COMPRESSED AIR SYSTEM QUALIFICATION
Compressor is installed to supply oil free (Non-lubricated) type of air to operate the various
equipment and mechanical application like pneumatic valve actuation etc.
Performance Qualification (PQ):
During PQ, Performance checks shall be performed where the compressed air shall directly come
into contact with the product e.g. Rapid Mixer Granulator, Auto coater etc. and following
parameters shall be checked at the point of use.

Oil mist test.

Microbial test.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 23 of 25
Review Date
14.11.2007

11.0 COMPUTER SYSTEM VALIDATION:


Computerized systems linked operations are used in manufacturing, utility and quality functions.
Software and accessories which has direct impact on the quality of product shall be covered for
validation.
These include

PLC in Critical Process Equipment in case applicable.

Data acquisition system in water system.

Software for critical Instrument in Quality function.

Material inventory system

Depending upon applicability, validation exercise will cover the test for data acquisition, system
security, access control, audit trail, validity of data, etc.

12.0: VALIDATION SCHEDULE:


Annexure-I

: Process equipment

Annexure-II

: Laboratory instrument

Annexure-III

: Utility Qualification

Annexure-IV

: Process validation and cleaning validation

Annexure-V

: Computer system validation

Status of Validation Schedule will be recorded and reviewed annually to ensure that the Validation
Activity is progressing as per plan and priority and to identify and activate the need that is required
to be addressed.

Document No.
ALB/F/VMP/001-01
Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

ALEMBIC LIMITED
BADDI
VALIDATION MASTER PLAN
QUALITY ASSURANCE DEPARTMENT

Page 24 of 25
Review Date
14.11.2007

13.0. SUPPORTING PROGRAMS


The VMP is meant to be a Validation Life Cycle document. It thus covers the activities and
requirements from project inception to testing completion and on through a program of continuous
monitoring and evaluation. Associated with this effort are Quality Assurance /Quality control
procedures meant to support and update the validation effort. These programs include the
following:
Document /Change control:
A procedure must be in place to govern and capture documentation creation, revision and control.
This procedure shall be applicable to all validation documentation and must designate the review
and approval responsibilities of various functional groups. Archival guidelines shall include
duration of record retention, and means of storage and retrieval.
Standard Operating Procedures:
SOPs should exist to address such cGMP issues as facility sanitation, waste collection and disposal,
the use of suitable rodenticides, insecticides, fungicides and fumigating agents, and building
maintenance.
Calibration:
A system should exist detailing the methods, frequency and documentation of the calibration
program including justification for a no calibration required status.
Preventative Maintenance:
This system should be indexed to distinct equipment identifiers and outline the maintenance
procedures required to ensure proper system functionality. This procedure shall identify the
appropriate documentation and frequency requirements.

Document No.
ALB/F/VMP/001-01

ALEMBIC LIMITED
BADDI

Supersede:
ALB/F/VMP/001-00
Effective Date
15.11.2005

VALIDATION MASTER PLAN

Page 25 of 25

QUALITY ASSURANCE DEPARTMENT

Review Date
14.11.2007

Training:
A program should exist to ensure and document that personnel will have the appropriate education,
training, and /or experience to perform their assigned functions. Personnel should be trained on
good sanitation practices, as well as the use of protective apparel to prevent product contamination.

14.0: REFERENCES:
14.1 Pharmaceutical inspection convention ( PIC/S) guideline - Aug'2001
14.2 Draft qualification and validation guidelines - European commissions -Jan'2000.
14.3 ISPE guidelines on Qualification and validation Vol. 5
14.4 SUPAC guidelines
14.5 Pharmaceutical Process validation, second edition Volume 57 edited by Robert.
A. Nash / Ira R. Berry.
14.6 ICH Harmonized Tripartite Guideline-Text on Validation of Analytical Procedures.