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GMP & GUIDELINES, PHARMA INDUSTRY GUIDELINES, PRODUCTION, QUALITY ASSURANCE,

QUALITY CONTROL, SOPS, VALIDATION

Validation Master Plan for Pharmaceutical

Industry
Date: 23/10/2018 0

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Prepared by Designation: Signature Date:

 
  

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Approver of the document for use

Date:

 
Approved by: Designation: Signature:

Table of contents:

1. Validation policy
2. Scope
3. Responsibility
3.1 Production department
3.2 Quality control department
3.3 Engineering department
3.4 Quality assurance department
4. Site summary
4.1 Facility
4.2 Equipment utility
4.3 Process
5. Validation approach
6. Equipment quali cation
6.1 User requirement speci cation (URS)
6.2 Design quali cation (DQ)
6.3 Factory acceptance test (FAT)
6.4 Installation quali cation (IQ)
6.5 Operational quali cation (OQ)
6.6 Performance quali cation (PQ)
7. Process Validation
8. Cleaning validation
9. Analytical method validation
10. Computer system validation
11. HVAC validation
12. Temperature mapping
13. Transport validation
14. Validation of aseptic process simulation (Media Fill)
15. Water system validation
16. Calibration
17. Revalidation
18. Acceptance criteria
19. Validation schedule
20. Standard operating procedure
21. Document template
22. Document control and identi cation
23. Change control
24. De nitions
25. Attachment
26. Reference
27. Revision history

1. Validation Policy 
 XXXX (company name) is committed to provide high quality product complying with
the regulatory requirements. Validation is performed at site in accordance with the
principle of regulatory guidance i.e. EudraLex Vol. 4, PIC/S, FDA and WHO etc. Below
principles should apply for validation:

The execution of validation should be in compliance with regulatory requirements.

Validation should reinforce GMP.

Quality risk management principles should be applied in determining the need,

scope and extent of validation.

Ongoing review should take place to ensure that the validated state is maintained
and opportunities for continuous improvement is identi ed.

Time, personnel and nancial requirements should be ensured for validation. 

2. Scope 

The scope of this document is to cover the validation activity of XXXX (company name)
and it covers the validation of process, equipment, utility and system. 

3. Responsibilities  

3.1 Production department: 

Execution of validation protocol, equipment trials and process trials.

Training of all manufacturing personnel in technical validation and GMP aspects.

Sampling and execution of process control in coordination with QA

Preparing reports or any deviation from process parameters.

Participating in preparing validation protocols.

Executing (PQ) and assisting in the execution (DQ, IQ and OQ) of validation
protocols.

Operating and maintaining plant, facilities, support systems and speci c

manufacturing process within its design limits, speci cations in coordination with
Engineering and Maintenance.

3.2 Quality control department:

 Testing of validation samples.

Ensuring that the laboratory systems and equipment/devices to be used in the

course of validation have been quali ed or validated.

Carrying out analytical methods validation.

Preparing reports on any deviations from analytical parameters.

Participating in preparing validation protocols.

Training of all Quality Control personnel in technical, validation and GMP aspects.

Participating in preparing validation protocols.

Preparing laboratory reports and summaries of nding with conclusions

3.3 Engineering department: 

Participating in preparation of validation protocols.

Preparing all drawings and related system engineering documents such as P and I
drawings, Instrument list, Building and room drawings, Operational manuals,
Operational recommendations, Maintenance requirements, spare parts lists,
Operational manuals

Equipment component identi cation, material control procedures, Calibration

requirements and procedures and equipment installation and system construction
procedures.

Co-ordination of the calibration activities for all critical instrumentation

3.4 Quality Assurance department: 

Coordinating the efforts to determine the system and equipment/devices to be

validated.

Coordinating and organizing the validation team.

Coordinating the preparation of validation protocols and execution for each system.

Conducting process validation by monitoring, sampling, testing and challenging the

speci c manufacturing process.

Training of personnel in support of validation / operations.

Participating in preparing validation protocols.

 Collecting and organizing the validation data.

Preparing the nal validation summaries and certi cation statements.

Tracking for routine / non-routine validation requirement.

Tracking for validation requirement based on review of guidelines / literatures.

4. Site summary

      4.1 Facility:

Site is involved in manufacturing of tablets, capsules, small volume and large volume
parenteral. There are dedicated blocks for sterile and non-sterile products. There is
common QC laboratory for both blocks. Warehouse for the storage of raw materials are
packaging materials are common, there is separate nished product storage area for
sterile and non-sterile products. There is separate entrance and exit for both the blocks.
Gowning procedure is followed based on area requirement. 

4.2 Equipment and utility:

Facility is having below mentioned key equipment and utility:

Rapid mixing granulator

Fluid bed dryer

Compression machine

Blister packing machine

Manufacturing vessel

Liquid lling machine

Double door autoclave

Tunnel sterilizer

Dry heat sterilizer

Laminar air ow

Auto-cartonator

Water system

Pure steam generator

 HVAC

Boiler

4.3 Process: 

Manufacturing process is divided in below steps:

1. Dispensing

2. Mixing

3. Filling

4. Packaging

5. Testing

6. Release 

5. Validation approach 

Validation is an integral part of GMP compliance system, it will be implemented through

all the areas that could affect the product quality. These areas are applicable to all
utilities, processes, equipment, laboratory instruments, analytical methods and cleaning
procedures identi ed in this validation master plan. In order to ensure success of the
validation; the support programs must be implemented and a proper sequence of
quali cations or validations activities shall be followed. 

6. Equipment quali cation 

Quali cation is the planning, execution and recording of tests on equipment and
systems that forms part of the validated process, to demonstrate that it will perform as
intended. For any new processing / testing equipment system following aspects of
quali cations has to be covered sequentially. The documentation will include
preparation of URS (User Requirement Speci cation), DQ (Design Quali cation), FAT
(Factory Acceptance Test), IQ (Installation Quali cation), Operational Quali cation
(OQ) and Performance Quali cation (PQ).

6.1 User Requirement Speci cation (URS)

The URS provides the list of components and their speci cation, functionality in the
desired equipment, prior to purchase of the equipment. URS is required for all new
GMP equipment, items requiring validation. The speci cation should be developed,
even if it is retrospective to equipment order, as it aids in de ning quali cation
requirements.

6.2 Design Quali cation (DQ)

It demonstrates the veri cation of the user requirements for equipment and its
ancillary systems. Design quali cation is performed prior to installation of the
equipment. 

6.3 Factory Acceptance Test (FAT) 

Factory Acceptance Test ensures the veri cation of installation parameters, operating
parameters and the functional checks at the vendors site itself prior to dispatch of the
system / equipment to the customers site. This quali cation also ensures any
malfunctioning of any component or any changes are required as per the new
requirement that can be made to the system / equipment and the correct equipment
can be installed.

6.4 Installation Quali cation (IQ)

Installation Quali cation demonstrates that facility, equipment, control system, utility
and selected components are made as per the required standard, installed as per the
approved design and at the speci ed locations with proper identi cation.

The following sections shall be covered in installation quali cation:

Objective

Scope

System description

Component identi cation

Utilities veri cation

Spare parts veri cation

Equipment installation and location documentation

 Standard operating procedures documentation

Purchase orders, speci cations and manuals documentation

Engineering drawings veri cation

Preventive maintenance program

Calibration documentation

6.5 Operational quali cation (OQ)

Demonstrate that facility, equipment, control system utilities and the components of
each of the system performed as intended throughout the anticipated operating ranges.

Below is the non-exhaustive list of contents of operational quali cation document:

Objective

Purpose

Critical variables to be met. All critical variables with respect to equipment, area or
system under quali cation to be mentioned

Relevant documents like training schedule, layout, SOP etc. completed

Any changes made against the formally agreed designed parameters

Review (inclusive of follow up action, if any)

Approval

6.6 Performance Quali cation (PQ)

Documented verification that the equipment or system performs consistently and

reproducibly within defined specifications and parameters in its normal operating
environment (i.e. in the production environment).

The performance quali cation will also include testing, that demonstrates that all
intermediate and nal product speci cations are met. This phase shall be executed once
the process parameters have been de ned.

The following sections shall be covered in performance quali cations:

Purpose
 Critical variables to be met: All critical variables with respect to equipment, area or
system under quali cation to be mentioned.

Documents to be attached: Relevant documents like installation certi cate, Training

schedules, layouts etc., to be attached.

Any changes made against the formally agreed design parameters.

Review (Inclusive of follow up action, if any)

Recommendation

Approval

7. Process Validation 

Process validation is de ned as a documented evidence to prove that a speci c process

when carried out within de ned parameters will consistently produce an end product
meeting its predetermined speci cations.

Prospective process validation shall be carried out on the exhibit batches / Pilot scale
batches prior to commercial production. The number of batches shall be decided as per
the requirements of the speci c market and risk assessment.

Concurrent process validation shall be performed on initial three commercial batches

of new product.

Revalidation shall be performed when there is change in process, material, change in

major equipment used, change in batch size, change in facility and change in vendor.

Process validation protocol will cover below points:

Objective

Scope

Responsibility

Time schedule

Validation team members,

Environmental monitoring

Reference documents to be followed

 Product details

Manufacturing formula

Equipment and instrument details

Process ow diagram

Quality Risk analysis

Sampling plan and acceptance criteria

Review and certi cation etc.

8. Cleaning Validation

Cleaning validation should be performed to provide documented evidence that the

procedure being followed for cleaning of equipment and accessories is effective and
removes residue of previous batch/product up to a predetermined acceptance level,
using a well-de ned protocol and acceptance criteria. Two methods are employed for
sampling during cleaning validation. They are rinse method and swab method.

The cleaning validation approach is established on process equipment related cleaning   

 procedures and/or cleaning mechanisms. Procedures are established for cleaning. Each
process, equipment will have a cleaning SOP or the operational SOP describing the
cleaning procedure that will address all cleaning aspects for the equipment as
applicable to each products. The cleaning validation protocol is developed to show that
the established cleaning procedure will effectively and consistently clean the unit for
which it is designed. One of the objectives of the cleaning validation protocol is to
establish an acceptable level of active ingredient from one product that can be carried
on to the next product to be processed on the same equipment. A second objective is to
prove that the accepted cleaning procedure removes any detergent residuals (if used),
wherever applicable.

The acceptance criteria are established based on pharmacological activity, toxicity,

and/or any other applicable product characteristics. Introduction of new products or
other potential contaminants shall be assessed to consider their impact on the
validated state of cleaning procedures.  

9. Analytical method validation  

An acceptable method of analysis is based on sound scienti c principles and validated
for the purpose intended, and revalidated in case of signi cant change. All test methods
used to analysis of products, raw material etc. should be validated. Such methods may
include, but are not necessarily limited to:

Test methods (pharmacopoeial and non-pharmacopoeial) for nished product

testing

Test methods for raw material and consumables testing

Test methods used for stability programs

Test methods for In-process checks

Both chemical and microbiological test methods should be validated.

10. Computer System Validation

All computer systems performing critical GMP functions are required to be validated.
Such systems may include, but are not limited to:  

Manufacturing automation computer system/software: PLCs (Programmable

logical controllers), MMI (Man Machine Interphase), BMS (Building Management
System) etc.

Production monitoring computer system/software: Material management

software, Material requisition and issuance software, work order management
software, stock management software.

Laboratory computer system/software: Laboratory management software,

computer system associated with HPLC, GC, LCMS/MS, UV-VIS spectrophotometry
etc., laboratory calculations related software.

Batch release and other QMS system related computer system/software: Batch
release software, QMS recording software, labelling software.

Computer system validation protocol shall contain following non-exhaustive content:

– Objective
– Scope

– Roles and responsibilities

– Tools required

– Procedure

– Acceptance criteria

– Test data sheet

– Reference

11. HVAC Validation 

The objective of HVAC system quali cation is to verify the new/existing HVAC system
is able to give the required environmental condition in the rooms to which the HVAC
caters. These parameters are as follows:

Temperature of the area

Relative Humidity in the areas

Differential pressure in the area with respect to adjacent areas

Number of air changes, fresh air changes

PAO testing of lters

Non-viable particle monitoring

Microbial (viable) monitoring

HVAC validation is carried out as per ISO14644.

12. Temperature mapping

All new temperature-controlled storage areas must be temperature-mapped as part of

a fully documented veri cation process, before the installation is commissioned and
handed over by the installer.
The temperature mapping procedures should:

demonstrate the air temperature pro le throughout the storage area, when empty
and in a normal loaded condition;

de ne zones which should not be used for storage of products (for example areas in
close proximity to cooling coils, cold air streams or heat sources); and

if required, demonstrate the time taken for temperatures to exceed the designated
limits in the event of a power failure.

13. Transport validation

Finished products and samples should be transported from manufacturing sites in

accordance with the conditions de ned in the marketing authorisation, the approved
label, product speci cation le or as justi ed by the manufacturer.

A risk assessment should be performed to consider the impact of variables in the

transportation process other than those conditions which are continuously controlled
or monitored, e.g. delays during transportation, failure of monitoring devices, topping
up liquid nitrogen, product susceptibility and any other relevant factors.  

14. Validation of aseptic process simulation (Media Fill)

The aseptic process simulation is indented to prove high degree of con dence to ful l
the quality attributes of sterile product. 

All aseptic processing lines are subjected to media ll trials on six monthly basis.

Aseptic processing lines are subjected to liquid media ll in the product containers,
instead of the product. The entire production process from manufacturing to lling
is same only using nutrient liquid broth instead of product.

The type/size of container used in media ll trials is varied every six months to cover
all pack size. 

15. Water System validation 

Validation of new water system and periodic validation is necessary to ensure that the
water system unit will perform effectively as it is supposed to perform. Operational
considerations should be given including:

Start up, commissioning and quali cation

Monitoring

Maintenance

System reviews

Water systems are “direct impact systems”. Therefore, stages to be considered in

quali cation should include DQ, IQ, OQ, PQ.

DQ: Design review in uenced by source water and required water quality.

IQ: Installation veri cation of the system

OQ: Operational quali cation

PQ: PQ demonstrates consistent and reliable performance of the system.

Performance quali cation involves three phase approach recommended over
extended period – proves reliability and robustness.

Phase-I: It involves exhaustive sampling for 2-4 weeks. It involves chemical and
microbiological monitoring.

Phase-II: It involves sampling for 2-4 weeks. It involves chemical and microbiological
monitoring. It demonstrates consistent production and delivery of water of the
required quantity and quality when the system is operated in accordance with the
SOPs.

Phase-III: It is carried out over one year after the satisfactory completion of phase 2.
Water can be used for manufacturing purposes during this phase. It demonstrates that
extended reliable performance of water system and also seasonal variations are
evaluated.

After Phase 3 – system review needed. Based on review including results, routine
monitoring plan will be established. Trending is done for all parameters.

Water system shall be validated by challenging of various parameters like level alarm,
conductivity set points, temperature set points, TOC set points. Sampling frequency for
chemical testing and microbial testing shall be increased during validation period.
If any major change / modi cation in the design of water system affecting water
system unit, water system to be re-quali ed by authorization of the documented
change proposal through the change control procedure.

16. Calibration 

All measuring equipment (temperature, weight etc.) shall be periodically calibrated,

frequency of calibration for critical temperature and pressure gauges are once in six
months.

17. Revalidation 

Revalidation is the scheduled re-testing and certifying of equipment, products,

procedures or methods as required by assessment. Revalidation shall be done
periodically to assess the tness of existing process or in case of any signi cant change
in equipment, material, process or system. Revalidation frequency is de ned in below
table:

Validation Type Revalidation Frequency

Media Fill 6 months

Sterilisers 12 months

Stability chamber 12 months

Grade A area HVAC 6 months

Above Grade A area HVAC 12 months

Performance quali cation 5 years

Process validation 5 years

Stability chambers 12 months

Other items may be considered for routine revalidation if recommended as a result of

initial validation outcomes.

18. Acceptance Criteria 

Each validation protocol must include acceptance criteria which should be based on
scienti c rationale, regulatory/GMP guidance, suppliers recommendation/manual and
operation/function. 

19. Validation schedule 

Validation schedule shall be prepared annually for equipment, process, system and
utility. Validation shall be carried out as per schedule. 

20. Standard operating procedure

Following SOPs are available at site for execution of validation activity:

SOP number SOP Title

SOP01 Equipment quali cation

SOP02 Process validation

SOP03 Water system validation

SOP04 Aseptic process simulation study (Media ll)

SOP05 Computer system validation

SOP06 Temperature mapping

SOP07 Revalidation

SOP08 Equipment calibration

SOP09 Transport validation

21. Document Template 

Validation document template is available at site, however additional contents can be

included wherever deemed necessary. Template helps to maintain the consistency and
uniformity among the validation documents.

Internal templates of following documents are in place:

User requirement speci cation

 Installation quali cation

Operational quali cation

Performance quali cation

Process validation protocol

Temperature mapping protocol

Transport validation protocol

Computer system validation protocol

Aseptic process simulation study protocol

Validation report

22. Document control and identi cation

Validation document shall be managed, handled and retained as per document control
and handling SOP. Each validation document shall be numbered as per document
numbering SOP.

23. Change control

All changes to validated equipment, processes, systems and methods should be formally
requested, documented and accepted by representative of concerned department. The
likely impact (risk assessment) of the change on the product should be evaluated and
the need for and extent of re-validation discussed. The change control system should
ensure that all noti ed or requested changes are satisfactorily investigated,
documented and authorized.

24. De nitions

Term/Abbreviation De nition

An organization of engineering components

that have a de ned operational function (e.g.
System
piping, instrumentation, equipment,
facilities, computer hardware/ software etc).

The process of evaluating the impact of the

operating, controlling, alarming, and failure
Impact Assessment
conditions of a system, on the quality of the
product.
Critical Component
Non-Critical Component
Calibration
Concurrent Validation
Cleaning Validation
Design Quali cation (DQ)
Factory Acceptance Test (FAT)
Installation Quali cation (IQ)
Operational Quali cation (OQ)
A component within a system where the
operation, contact, data, control, alarm, or
failure may have a direct impact on the
quality of the product.
A component within a system where the
operation, contact, data, control, alarm, or
failure may have an indirect impact or no
impact on the quality of the product.
The performance of tests and retests to
ensure that measuring equipment (e.g. for
temperature, weight, pH) used in a
manufacturing process or analytical
procedures (in production or quality
control) give measurements that are correct
within established limits.
Validation carried out during routine
production of products intended for sale.
A documented evidence that a cleaning
procedure is consistent in reducing product 
and cleaning agent residue from equipment
within the acceptance limit and to
demonstrate that routine cleaning and
storage of equipment does not allow
microbial proliferation.
Design Quali cation is documented
evidence that the proposed design of the
facilities, systems and equipment are
suitable for intended purpose.
Testing conducted at the supplier’s factory
usually involving the user to determine
whether or not a system satis es its
acceptance criteria and to enable the
customer to determine whether or not to
accept the system.
Installation Quali cation is a documented
veri cation that the facilities, systems and
equipment’s as installed or modi ed; comply
with the approved design and
manufacturer’s recommendations.
The documented action of demonstrating
that process equipment and ancillary
systems work correctly and operate
consistently in accordance with established
speci cations for the anticipated range of
operation.
  Performance Quali cation is the
documented evidence which veri ed that
the equipment or system operates
Performance Quali cation (PQ)
consistently and gives reproducibility within
de ned speci cations and parameters for
prolonged period.

Documented evidence, which provides a

high degree of assurance that a speci c
process will consistently produce a product
meeting its predetermined speci cations
Process Validation and quality characteristics.

Validation carried out during the

Prospective Validation
development stage by means of a risk
analysis of the production process, which is
broken down into individual steps; these are
then evaluated on the basis of past
experience to determine whether they may
lead to critical situations.

Quali cation is the act of planning, carrying

out and recording of tests on equipment and
systems, which form part of the validated
process, to demonstrate that it will perform
Quali cation as intended.

Validation exercise to validate the system

/equipment /process / method which is in
Re-validation/
state of validation & changes done which
may impact its earlier state of validation.
Requali cation
 

User Requirement Speci cation (URS) A requirement speci cation that describes,
what the equipment or system is supposed
to do, thus containing at least asset of
criteria or conditions that have to be met.

 
 Validation is the establishment of
documented evidence that a system does
what it is supposed to do. It is the collection
and evaluation of data, which ensures that
the manufacturing process including
equipment, building, materials are capable
Validation
of achieving the intended results on the
consistent and continuous basis.

The validation protocol is a written plan

stating how validation will be conducted,
including test parameters, product
characteristics, and production equipment
and decision points on what constitutes
Validation Protocol
acceptable test results.

The validation report is a written report on

the validation activities, the validation data
and the conclusions drawn.
Validation Report
 

A document providing information on the

Company’s validation work programme, it
should de ne details of and time scales for
the validation work to be performed.
Responsibilities relating to the plan should
Validation Master Plan
be stated.

Worst Case A condition or set of conditions

encompassing upper and lower processing
limits which pose the greatest chance of
product or process failure when compared
to ideal conditions and which are actually
evaluated in the validation exercise.

 
25. Attachments

Attachment I: Annual validation schedule template

26. References 

EudraLex – Volume 4 – Good Manufacturing Practice- Annexure 15

PIC/S guide to Validation master plan installation and operational quali cation Non-
sterile process validation cleaning validation

27. Revision History

Date Revision Number Details of change

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in Pharmaceutical Industry Industry Industry

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In "Pharma Industry Guidelines" In "Pharma Industry Guidelines" In "Pharma Industry Guidelines"

VALIDATION MATER PLAN VMP VMP PHARMACEUTICALS

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