xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.

: xxxxxxxxxxxxxxxxx
Rev. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx
Effective Date: xxxxxxxxxxxxx Page 1 of 38
QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
PROCESS VALIDATION PROTOCOL FOR TABLETS
Protocol No. Effective Date.
: xxxxxxxx : xxxxxxxxxxxx
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
TABLE OF CONTENTS
S.NO. SECTION 1. 2. 3. 4. 5. 6. 7. 8. Protocol approval Purpose
Responsibilities Requirements Personnel Responsibilities
Validation parameters Limits Conclusion report Page No
Prepared By
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Production Manager
Manager QC&A
Plant head
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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
1. PROTOCOL APPROVAL
This document is prepared by the validation and the GMP
compliance (QA) team of xxxxxxxxxxxxxxxxx under the authority of
Manager QC & A. Hence this document before being effective shall
be approved by xxxxxxxxxxxxxxx QA team.
Name Manager production Manager Engineering
Signature
Date
Manager QA
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
2. PURPOSE
Process validation is establishing documented evidence which
provides a high degree of assurance that a specific process (such
as manufacturer of pharmaceutical dosages forms) will
consistently produce a product meeting its predetermined
specifications and quantity characteristics.
3. RESPONSIBILITIES
S.NO. Activity 1. 2. 3. 4. 5. 6. Preparation of protocol Chemical
analysis and sampling Microbial analysis & sampling Preparation
of validation Report Review of validation protocol & report
Approval of protocol & Report Responsibility QA chemist QC
chemist Microbiologist Dy Manager QC QA department, Production
Department Plant Head
4. REQUIRMENTS: NIL 5. PERSONNEL RESPONSIBILITIES:
The perfect validation program necessitates various departments
involvement mainly to balance the total system functioning for
its effective utilization for success criteria compliance on
regular basis. Quality assurance department initiates validation
program with protocol, specified procedure and success criteria.
Quality control personnel are responsible for the validation run
as per the protocol and during validation maintenance departments
have to cooperate to the quality control personnel.
Prepared By
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Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
6. VALIDATION PARAMETERS:
Process Description / Flow Sheet The information given below
provides a general description of the process. Detailed
information for the manufacturing will be supplied separately in
the Batch Processing Record. 1 Prepare production order and
according to that issue the BPR 2 RM dispensing as per Bill of
material 3 Input check in presence of QA person 4 Granulation 4.1
Sifting 4.2 Premixing 4.3. (a) Wet granulation Binder
Preparation Mixing Wet milling Drying Dry milling Slugging,
Milling (if required) Lubrication 4.3 (b) Dry Granulation Mixing
Slugging, Milling (if required) Lubrication 5 Tablet compression
6 Tablet coating 7 Tablet packing
Formulation: Prepared By Reviewed by Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Batch Size: Sr No 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Ingredients/Excipients Unit per Tablet Std. Qty. Overages
Dispensed Quantity Weight by Checked by
FLOW SHEET:
Prepare production order and according to that issue the BPR RM
dispensing as per Bill of material
Prepared By
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Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Input check in presence of QA person
GRANULATION Shifting
Dry Granulation
Premixing
Mixing Wet Granulation milling
Binder preparation
Drying Dry milling Mixing Slugging, Milling (if required)
Coating
Compression
Lubrication (Blending)
Tablet packing
Sampling point Typical Variables and responses: Granulated
Product
Prepared By
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QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
S. No. 1.
Process step Pre-blending
Control variables Blending time RPM Load size Order of addition
Load size Amount of granulating agent Solvent addition rate RPM
Granulation time Initial temperature Load size Drying temperature
program Air flow program Drying time Cooling time Screen type
Screen size Feed rate Load size RPM Blending time Compression
rate Granule feed rate Pre-compression force Compression force
Measured responses Blend uniformity
2.
Granulating
Density Yield
3.
Drying
Density Moisture content Yield
4.
Sizing
5.
Blending
6.
Tableting
Granule size distribution Loose drying Packed density Blend
uniformity Flow characteristics Particle size distribution Weight
variation Friability Hardness Thickness Disintegration time
Dissolution Dosage from uniformity
Equipments A detailed list of equipment used for validation
together with the cleaning status will be provided in the
manufacturing documents. Prepared By Reviewed by Approved by

Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
List of SOPS, Validation & Qualification report used as
references Sr. No. 1 2 3 4 5 6 7 8 9 10 11 12 Name of Equipment
Equipment ID. Qualification details SOP No
Critical Process Parameters: Critical stages: Following critical
stages required to be validated to provide a high degree of
assurance for the manufacturing of tablets. Sr. No. STAGE
Prepared By Parameters Reviewed by Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
1.
Premixing
RPM of mixer blade Load size Total time of mixing Uniform mixing
by Assay analysis
2.
Granulation
Mixer blade speed Load size Binder Quantity Binder addition rate
Binder addition time Temperature of binder Mixing time after
binder addition /Total granulation time Uniformity of granulated
mass (Visual Checking)
3.
Drying
Dryer outlet temperature Dryer inlet temperature Drying load
Total drying time Weight of the Dried granules
4.
Milling
Speed of machine Direction of knives
5.
Lubrication
Load size Occupancy Speed of equipment (RPM) Total time of mixing
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager

Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Assay - (individual sample) 6. Compression Temperature of area
Humidity of area Machine Details Weight variation of 20 tablets
Average weight of tablet Disintegration time Friability Diameter
(Length) Thickness Hardness Assay Content uniformity Dissolution
7. Coating Temperature of area Temperature of blower Speed of
Coating Pan (RPM) Spray Rate Bed Temperature Air Pressure Total
Coating solution used Weight Built up Weight variation of 20
tablets Prepared By Reviewed by Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Assay Disintegration time Dissolution 8. Packaging Forming roller
temperature. (for Blister Packing) Sealing roller temperature
Sealing roller Pressure Speed of machine Seal integrity Assay
Dissolution 9. Packaging (bulk packing) Seal integrity Counter
Checking from 10 Jars at different Time intervals Sealing
temperature
Sr. No 1
Process / Variable Blend Manufacturing Sifting
Machine setting ( Control Variables) Visually Inspection
Remarks No visible foreign particulate matter is observed
Prepared By
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Approved by
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QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Premixing Stage Uniform mixing by Assay analysis Granulation
Binder Preparation Granulation 2 Wet milling Drying Dry milling
Lubrication
Variation between the results shall not be more than 2%
3 4 5
Tablet compression Tablet coating Tablet packing
Finely divided material without free powder and excessive wetted
lumps. Material was finely divided Loss on drying Between 2.0 to
5.0% Finely divided granules are observed Variation between the
results Assay and Sieve analysis shall not be more than 2% Wt.
Variation, Hardness, Physical Parameter Thickness, DT,
Dissolution and Assay Weight gain, weight variation and DT Leak
Test
PREMIXING: Sampling Qty.: -Depends on quantity required for
analysis. Sampling Time: - (bracketing the time between 2 to 3
intervals of total mixing time) While mixing is on: After ____
minutes,
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
After ___
minutes,
After _____ minutes ______ minutes (Top , Middle & Bottom) Total
samples: 9 Samples _______ minutes (Top , Middle & Bottom) ______
minutes (Top , Middle & Bottom)
MIXING: Sampling Qty.: -Depends on quantity required for
analysis. Sampling Time: - (bracketing the time between 2 to 3
intervals of total mixing time) While mixing is on: After ____
minutes, After ___ minutes,
After _____ minutes ______ minutes (Top , Middle & Bottom) Total
samples: 9 Samples _______ minutes (Top , Middle & Bottom) ______
minutes (Top , Middle & Bottom)
DRYING:
Sampling point for drying stage: Top View Sampling Top B2 TOP
VIEW Prepared By Reviewed by B3 Approved by T2
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
T1 Front side ----- Sampling Points Sampling Qty.: -Depends on
quantity required for analysis. Sampling Time: - (bracketing the
time between 2 to 3 intervals of total mixing time) While Drying
is on: After ____ minutes, After ___ minutes, Bottom B1
T3
After _____ minutes ______ minutes (Top , Middle & Bottom) Total
samples: 9 Samples MILLING: Sampling Qty.: -Depends on quantity
required for analysis. Sampling Time: - (bracketing the time
between 2 to 3 intervals of total milling time) While milling is
on: After ____ minutes, After ___ minutes, _______ minutes (Top ,
Middle & Bottom) ______ minutes (Top , Middle & Bottom)
After _____ minutes Prepared By Reviewed by Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
______ minutes (Top , Middle & Bottom) Total samples: 9 Samples
_______ minutes (Top , Middle & Bottom)
______ minutes (Top , Middle & Bottom)
SAMPLING POINT FOR LUBRICATION (BLANDING) STAGE: Name of Blender:
(DOUBLE CONE BLENDER) Loading Valve Sampling Points B3 B2 T3
Prepared By T2 Designation QA chemist T1 Reviewed by Approved by
T2
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
M T4 T 1 T3
T1
B1
B4 B2 B1
B3
Sampling points T1, T2, T3 for top T4 B4 for middle, B1, B2, B3
for bottom sampling.
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Sampling Qty.: -Depends on quantity required for analysis.
Sampling Time: - (bracketing the time between 2 to 3 intervals of
total mixing time) While mixing is on: After ____ minutes, After
___ minutes,
After _____ minutes ______ minutes (Top , Middle & Bottom) Total
samples: 9 Samples _______ minutes (Top , Middle & Bottom) ______
minutes (Top , Middle & Bottom)
COMPRESSION: Sampling Qty.: -Depends on quantity required for
analysis. Sampling Time: - (bracketing the time between 2 to 3
intervals of total compression time) After ____ minutes, After
___ minutes,
After _____ minutes ______ minutes _______ minutes ______ minutes
Total samples: 3 Samples
COATING: Prepared By Reviewed by Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Sampling Qty.: -Depends on quantity required for analysis.
Sampling Time: - (Bracketing the time between 2 to 3 intervals of
total coating time) While coating is on: After ____ minutes,
After ___ minutes,
After _____ minutes ______ minutes Total samples: 3 Samples
_______ minutes ______ minutes
Sampling: Stage / Test Parameter Equipment (Size, Location &
Time) Premixing Stage Mixing Drying Mixing Lubrication Tablet
compression Tablet coating Tablet packing Variation between the
results of Assay shall not be more than 2% Loss on drying Between
2.0 to 4.0% Variation between the results of assay shall not be
more than 2% Physical Parameter (I.P.Q.C) Weight Gain Leak Test
Acceptance Criteria
Recording of data & Data treatment: Data Recording: Prepared By
Reviewed by Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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Effective Date: xxxxxxxxxxxxx Page 20 of 38
QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
The data obtained from the various analysis & observations shall
be recorded in the Data recording sheet for first three
commercial batches. Data Recording Sheet No. Sheet No 1 Sheet No
2 Sheet No 3 Sheet No 4 Sheet No 5 Sheet No 6 Sheet No 7 Sheet No
8 For recording Mixing stage data For recording Loss on drying
data For recording Lubrication stage data For recording
Compression stage data For recording Coating stage data For
recording Packing stage data For recording of analysis report For
recording general utilities /equipment / method qualitical
/results. Sheet No 9 For recording analytical method validation.
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Data recording sheet no I Mixing Stage: Equipment name
Identification no Ingredients and sequence of material addition
RPM of Mixer Blade Capacity Mixing time Standard Weight of Tablet
: : : : : : : Minutes Date
Method reference: As per assay procedure given in finished
product specification. Blended material to be analyzed for
______________________________ Plan: Samples to be drawn of
mixing from 3 different locations (Top, Middle & Bottom) Result
after mixing _________________ minutes Sampling Detail Top Middle
Bottom Mean Standard Deviation % Relative standard deviation
Results
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx

Rev. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx
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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Result after mixing _________________ minutes Sampling Detail Top
Middle Bottom Mean Standard Deviation % Relative standard
deviation Results
Result after mixing _________________ minutes Sampling Detail Top
Middle Bottom Mean Standard Deviation % Relative standard
deviation Analyst: Remarks: Checked By: _________________________
Date: ____________________ Date Results
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Data recording sheet no II Loss on Drying Stage: Equipment name
Dryer outlet temperature Dryer inlet temperature Drying Load
Total Drying time Weight of the dried granules : : : : : :
Minutes Date
Method reference: Loss on drying procedure by IR moisture
balance. Plan: Material to be analyzed for Loss on drying Samples
to be drawn from 3 different locations
Sample Weight taken % LOD
East
West
North
South
Average
Limit
Remarks:
Checked By: _________________________
Date: ____________________
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Data recording sheet III Lubrication Stage: Equipment name
Identification no Capacity Occupancy Speed of equipment Mixing
time Standard Weight of Tablet : : : : : : : Minutes Date
Method reference: As per assay procedure given in finished
product specification.
Lubricated material to be analyzed for % of active content
______________________________
Plan: Samples to be drawn at of blender from 3 different
locations (Top, Middle & Bottom)
Result after mixing _________________ minutes Sampling Detail Top
Middle Bottom Results
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Mean Standard Deviation % Relative standard deviation
Result after mixing _________________ minutes
Sampling Detail Top Middle Bottom
Results
Mean Standard Deviation % Relative standard deviation
Result after mixing _________________ minutes
Sampling Detail Top Middle Bottom
Results
Mean Prepared By Reviewed by Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Standard Deviation % Relative standard deviation
Remarks:
Checked By: _________________________
Date: ____________________
Data recording sheet IV Compression Stage ________ Station
compression machine Prepared By : Reviewed by Approved by Date
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Identification no Capacity RPM Punch Size Temperature of area
Humidity of area Weight of 20 Tablets Average Weight of tablet
Disintegration Time Dissolution (If required) Friability
Thickness Hardness Assay Content of uniformity (If required)
: : : : : : : : : : : : : : : NMT 1.0% NMT 15 minutes 13 to 28
RPM
Method reference: As per In-process check procedure.
Plan: Compressed tablets to be analyzed for: Average weight,
Weight variation and Physical parameter at an interval of 2 hours
Requirement RPM: RPM: RPM: Time Prepared By Reviewed by Approved
by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Average weight Thickness mm Hardness in kg./sq. cm2 Friability in
% DT in min. Weight variation after validated RPM __________
Time
Average Weight
Thickness
Hardness
Friability
Disintegration
Weight variation: Time
Time
Time
Time
Time
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Remarks:
Checked By: _________________________
Date: ____________________
Data recording sheet V Coating Stage Name of equipment
Identification no Capacity Prepared By : : : Reviewed by Approved
by Date
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Speed of coating pan Temperature of area Temperature of blower
Spray rate Bed temperature Air Pressure Total coating solution
used Weight build up Weight of 20 Tablets Average Weight of
tablet Disintegration Time Dissolution (If required) Assay
: : : : : : : : : : : : Not more than
Method reference: As per In-process check procedure.
Plan: Coated tablets to be analyzed for Weight gain, weight
variation and DT. At an interval of __ hours Date Time Initial
weight Average weight Final weight Average weight % Weight gain
DT in min.
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Weight variation: Time Weight variation
Remark: Checked By: _________________________ Date:
____________________
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Data recording sheet VI Packing Stage Name of equipment
Identification no Capacity Forming roller temperature (For
blister packing) Sealing roller temperature Sealing roller
pressure Speed of machine Seal integrity (Leak
test) : : : : : : : : Date
Method reference: As per In-process check procedure. Plan: Packed
tablets to be analysed for Leak test at an interval of __ hours
Date Time Leak Test No of strips to be taken Results Remarks
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Data recording sheet VII Analysis Report Product Name: Batch No.:
Mfg. Date: Test method reference: In house Sr. No. Test 01 02 03
04 05 5.1 Description Batch size: Exp. Date: Composition:
Specification Results Remark
5.2
5.3
5.4
Remark: Result: The sample referred above complies / does not
comply with the standard prescribed as per In house
Specification. Data recording sheet VIII Prepared By Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Sr No
Name of critical equipment / Utilities
Qualification / Validation file reference No
Date of Qualification / Validation
1 2 3 4 5 6 7 8 9 10 11 12 13 14 Sr No 15 Name of critical
equipment / Utilities Qualification / Validation file reference
No Date of Qualification / Validation
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
16 17 18 19 20 21 22 23 24 25 26 27 28 Utilities: 1 2 3 4 5 6 AHU
System Water System Compressed Air Steam Lightning Drain
Data recording sheet IX
Prepared By
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QA chemist
Production Manager
Manager QC&A
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Date Format No.: xxxxxxxxxxxxxx

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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Remark: Analytical Method Validation protocol attached
Prepared By
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Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx

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Rev. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx
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QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
Conclusion Sr. No. 1. 2. Stage Sifting Premixing Stage 3. 4.
Drying Lubrication Acceptance criteria No visible foreign
particulate matter is observed Variation between the results
shall not be more than 2% Between 2.0 to 4.0% Variation between
the results shall not be more than 2% 5. Tablet compression
Average weight of tablets is within ____of std. weight.
Tablets shall meet requirement of physical parameter and FP
specification. 6. Tablet coating Tablets shall meet the
requirements for weight gain, weight variation and
disintegration. Coated tablets shall meet FP Specification 7.
Tablet packing Conclusion: Product
_________________________________ manufactured as per B.M.R. No
_____________ meets predefined acceptance criteria. Analysis By
Date Approved By Date Packed tablet shall meet the requirement
for leak test Observation
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
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xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx

Rev. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx
Effective Date: xxxxxxxxxxxxx Page 38 of 38
QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS
7. LIMITS: As pre relative STPs
8. CONCLUSION REPORT
Summary report will contain discussion and conclusion , which
clearly states the successful achievement of objective of
validation studies and recommended concentrations required for
sanitization, disinfections and equipment sanitization.
Note: Extra pages for conclusions can be used as per requirement.
Prepared By
Reviewed by
Approved by
Designation
QA chemist
Production Manager
Manager QC&A
Plant head
Date Format No.: xxxxxxxxxxxxxx