xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx Rev.

:00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 1 of 33

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 Date Format No.: xxxxxxxxxxxxxx

Production Manager

Manager QC&A

Plant head

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx Rev. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 2 of 33

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

1. PROTOCOL APPROVAL
Prepared By

Reviewed by

Approved by

Designation QA chemist Date Format No.: xxxxxxxxxxxxxx

Production Manager

Manager QC&A

Plant head

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx Rev. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 3 of 33

QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS

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 Manager QA

Signature

Date

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. Prepared By Reviewed by Approved by

Designation QA chemist Date Format No.: xxxxxxxxxxxxxx

Production Manager

Manager QC&A

Plant head

specified procedure and success criteria. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 4 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS 3. RESPONSIBILITIES S. 3. REQUIRMENTS: NIL 5.NO. 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. 5. 2. Quality assurance department initiates validation program with protocol. 1 Prepare production order and according to that issue the BPR 2 RM dispensing as per Bill of material Prepared By Approved by 3 Input check in presence of QA person Reviewed by Designation QA chemist Date Format No. : xxxxxxxxxxxxxxxxx Rev. 6. 4. 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. VALIDATION PARAMETERS: Process Description / Flow Sheet The information given below provides a general description of the process. 6. Detailed information for the manufacturing will be supplied separately in the Batch Processing Record. 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. Production Department Plant Head 4. Activity 1.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head .xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.

Qty.3.2 Pre–mixing 4. Milling (if required) Lubrication 4.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head .1 Sifting 4. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 5 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS 4 Granulation 4.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.3 (b) Dry Granulation Mixing Slugging. (a) Wet granulation Binder Preparation Mixing Wet milling Drying Dry milling Slugging. Overages Dispensed Quantity Weight by Checked by Prepared By Reviewed by Approved by Designation QA chemist Date Format No. Milling (if required) Lubrication 5 Tablet compression 6 Tablet coating 7 Tablet packing Formulation: Batch Size: Sr No 1 2 3 4 5 6 7 Ingredients/Excipients Unit per Tablet Std. : xxxxxxxxxxxxxxxxx Rev.

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 6 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS 8 9 10 11 12 13 14 15 16 FLOW SHEET: Prepare production order and according to that issue the BPR RM dispensing as per Bill of material Input check in presence of QA person GRANULATION Shifting Premixing Mixing Binder preparation Dry Granulation Wet Granulation milling Drying Dry milling Mixing Slugging. Milling (if required) Prepared By Coating Compression Reviewed by Lubrication Approved by Designation QA chemist Date Format No.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . : xxxxxxxxxxxxxxxxx Rev.

:00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 7 of 33 (Blending) QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Tablet packing Sampling point Typical Variables and responses: Granulated Product Prepared By Reviewed by Approved by Designation QA chemist Date Format No.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . : xxxxxxxxxxxxxxxxx Rev.

1. : xxxxxxxxxxxxxxxxx Rev. Granulating 3.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 8 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS S. No. Process step Pre-blending 2. Drying 4.: xxxxxxxxxxxxxx Production Manager Manager QC&A Approved by Plant head . Sizing Blending Tableting 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 Density Yield Density Moisture content Yield 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 Qualification report usedReviewed by List of SOP’S. 5. 6. Validation &By as references Designation QA chemist Date Format No.

STAGE Premixing Parameters RPM of mixer blade Load size Total time of mixing Uniform mixing by Assay analysis 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) Dryer outlet temperature Dryer inlet temperature Drying load Reviewed by Approved by Total drying time Production Manager Manager QC&A Plant head 2. Critical Process Parameters: Critical stages: Following critical stages required to be validated to provide a high degree of assurance for the manufacturing of tablets. 1.: xxxxxxxxxxxxxx . No. No. : xxxxxxxxxxxxxxxxx Rev.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. 1 2 3 4 5 6 7 8 9 10 11 12 Name of Equipment Equipment ID. Sr. Drying Prepared By Designation QA chemist Date Format No. Granulation 3. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 9 of 33 Qualification details SOP No QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Sr.

: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . : xxxxxxxxxxxxxxxxx Rev.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. Packaging Prepared By Weight of the Dried granules Speed of machine Direction of knives Load size Occupancy Speed of equipment (RPM) Total time of mixing Assay . :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 10 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS 4. Milling Lubrication 6. (for Blister Packing) Sealing roller temperature Sealing roller Pressure Reviewed by Approved by Designation QA chemist Date Format No. Coating 8.(individual sample) 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 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 Assay Disintegration time Dissolution Forming roller temperature. Compression 7. 5.

Packaging (bulk packing) Speed of machine Seal integrity Assay Dissolution Sealing temperature Seal integrity Counter Checking from 10 Jars at different Time intervals Sr. Material was finely divided by Reviewed Approved by Designation QA chemist Date Format No.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . No Process / Variable Blend Manufacturing Sifting Machine setting ( Control Variables) Visually Inspection Uniform mixing by Assay analysis Remarks No visible foreign particulate matter is observed Variation between the results shall not be more than 2% 1 Premixing Stage Granulation Binder Preparation Granulation Wet milling Prepared By 4 Finely divided material without free powder and excessive wetted lumps. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 11 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS 9. : xxxxxxxxxxxxxxxxx Rev.

: -Depends on quantity required for analysis. Sampling Time: . Dissolution and Assay Weight gain.(bracketing the time between 2 to 3 intervals of total mixing time) While mixing is on: After ____ minutes. Thickness. Middle & Bottom) Total samples: 9 Samples MIXING: Sampling Qty. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 12 of 33 Between 2. : xxxxxxxxxxxxxxxxx Rev. Variation. Hardness. After _____ minutes ______ minutes (Top .: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . Middle & Bottom) Designation QA chemist Date Format No.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. After ___ minutes.0% Variation between the results shall not be more than 2% Wt. weight variation and DT Leak Test QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Drying Dry milling Lubrication 5 6 7 Tablet compression Tablet coating Tablet packing Loss on drying Finely divided granules are observed Assay and Sieve analysis Physical Parameter PREMIXING: Sampling Qty.0 to 5. Prepared By Reviewed by Approved by _______ minutes (Top . Middle & Bottom) ______ minutes (Top .: -Depends on quantity required for analysis. DT.

(bracketing the time between 2 to 3 intervals of total mixing time) Reviewed by While Drying is on: Prepared By Designation QA chemist Date Format No. Middle & Bottom) Total samples: 9 Samples DRYING: Sampling point for drying stage: Top View Sampling Top TOP VIEW B2 B3 T2 _______ minutes (Top .(bracketing the time between 2 to 3 intervals of total mixing time) While mixing is on: After ____ minutes. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 13 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Sampling Time: . Middle & Bottom) T1 Front side ----. After ___ minutes. Sampling Time: .xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.: -Depends on quantity required for analysis.Sampling Points Sampling Qty.: xxxxxxxxxxxxxx Production Manager Manager QC&A Bottom B1 T3 Approved by Plant head . Middle & Bottom) ______ minutes (Top . After _____ minutes ______ minutes (Top . : xxxxxxxxxxxxxxxxx Rev.

:00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 14 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS After ____ minutes. After ___ minutes. After _____ minutes ______ minutes (Top .: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head .: -Depends on quantity required for analysis. Sampling Time: . After ___ minutes. Middle & Bottom) Total samples: 9 Samples _______ minutes (Top . Middle & Bottom) Total samples: 9 Samples MILLING: _______ minutes (Top . Middle & Bottom) ______ minutes (Top . Middle & Bottom) Prepared By Reviewed by Approved by Designation QA chemist Date Format No.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. Middle & Bottom) ______ minutes (Top . : xxxxxxxxxxxxxxxxx Rev. Middle & Bottom) Sampling Qty.(bracketing the time between 2 to 3 intervals of total milling time) While milling is on: After ____ minutes. After _____ minutes ______ minutes (Top .

B2. T3 for top T4 B4 for middle. : xxxxxxxxxxxxxxxxx Rev. B1. Prepared By Reviewed by Approved by Designation QA chemist Date Format No.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head .xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 15 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS SAMPLING POINT FOR LUBRICATION (BLANDING) STAGE: Name of Blender: (DOUBLE CONE BLENDER) Loading Valve Sampling Points B3 B2 T3 T2 T1 M T4 T3 B3 T2 T1 T 1 B2 B1 B4 B3 B1 Sampling points T1. B3 for bottom sampling. T2.

(bracketing the time between 2 to 3 intervals of total mixing time) While mixing is on: After ____ minutes. Middle & Bottom) COATING: Sampling Qty. After _____ minutes ______ minutes (Top . :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 16 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Sampling Qty.(Bracketing the time between 2 to 3 intervals of total coating time) Reviewed by While coating is on:Prepared By Designation QA chemist Date Format No.: -Depends on quantity required for analysis. Sampling Time: . Middle & Bottom) Total samples: 9 Samples COMPRESSION: Sampling Qty.(bracketing the time between 2 to 3 intervals of total compression time) After ____ minutes. After ___ minutes. Sampling Time: . : xxxxxxxxxxxxxxxxx Rev.: xxxxxxxxxxxxxx Production Manager Manager QC&A Approved by Plant head .: -Depends on quantity required for analysis.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. After _____ minutes ______ minutes Total samples: 3 Samples _______ minutes ______ minutes _______ minutes (Top . After ___ minutes. Sampling Time: . Middle & Bottom) ______ minutes (Top .: -Depends on quantity required for analysis.

: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 17 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS After ____ minutes.Q.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.C) Weight Gain Leak Test Acceptance Criteria _______ minutes ______ minutes Recording of data & Data treatment: Data Recording: The data obtained from the various analysis & observations shall be recorded in the Data recording sheet for first three commercial batches.0 to 4.P. After ___ minutes.0% Variation between the results of assay shall not be more than 2% Physical Parameter (I. Prepared By Reviewed by Approved by Designation QA chemist Date Format No. After _____ minutes ______ minutes Total samples: 3 Samples Sampling: Stage / Test Parameter Premixing Stage Mixing Drying Mixing Lubrication Tablet compression Tablet coating Tablet packing Equipment (Size. : xxxxxxxxxxxxxxxxx Rev. Location & Time) Variation between the results of Assay shall not be more than 2% Loss on drying Between 2.

Sheet No 1 For recording Mixing stage data Sheet No 2 For recording Loss on drying data Sheet No 3 For recording Lubrication stage data Sheet No 4 For recording Compression stage data Sheet No 5 For recording Coating stage data Sheet No 6 For recording Packing stage data Sheet No 7 For recording of analysis report Sheet No 8 For recording general utilities /equipment / method qualitical Sheet No 9 /results. : xxxxxxxxxxxxxxxxx Rev. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 18 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Data Recording Sheet No.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. For recording analytical method validation. Prepared By Reviewed by Approved by Designation QA chemist Date Format No.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head .

: xxxxxxxxxxxxxxxxx Rev.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . Blended material to be analyzed for ______________________________ Plan: Samples to be drawn of mixing from 3 different locations (Top. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 19 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Data recording sheet no I Mixing Stage: Date Equipment name : Identification no : Ingredients and sequence of material addition : RPM of Mixer Blade : Capacity : Mixing time : Minutes Standard Weight of Tablet : Method reference: As per assay procedure given in finished product specification. 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 Date Format No.

:00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 20 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Result after mixing _________________ minutes Sampling Detail Top Middle Bottom Mean Standard Deviation % Relative standard deviation Result after mixing _________________ minutes Sampling Detail Top Middle Bottom Mean Standard Deviation % Relative standard deviation Analyst: Remarks: Checked By: _________________________ Date Date: ____________________ Results Results 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 Date : : : : : : Minutes Approved by Prepared By Reviewed by Method reference: Loss on drying procedure by IR moisture balance.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . : xxxxxxxxxxxxxxxxx Rev. Designation QA chemist Date Format No.

: xxxxxxxxxxxxxxxxx Rev.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 21 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Plan: Material to be analyzed for Loss on drying Samples to be drawn from 3 different locations Sample Ea st Weight taken % LOD W est No rth So ut h Average Limit Remarks: Checked By: _________________________ Date: ____________________ Prepared By Reviewed by Approved by Designation QA chemist Date Format No.

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx Rev. Middle & Bottom) Result after mixing _________________ minutes Sampling Detail Top Middle Bottom Results Mean Standard Deviation % Relative standard deviation Result after mixing _________________ minutes Prepared By Reviewed by Approved by Designation QA chemist Date Format No.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . Lubricated material to be analyzed for % of active content ______________________________ Plan: Samples to be drawn at of blender from 3 different locations (Top. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 22 of 33 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 Date : : : : : : : Minutes Method reference: As per assay procedure given in finished product specification.

: xxxxxxxxxxxxxxxxx Rev.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head .xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 23 of 33 Results QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Sampling Detail Top Middle Bottom Mean Standard Deviation % Relative standard deviation Result after mixing _________________ minutes Sampling Detail Top Middle Bottom Mean Standard Deviation % Relative standard deviation Remarks: Checked By: _________________________ Results Date: ____________________ Prepared By Reviewed by Approved by Designation QA chemist Date Format No.

:00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 24 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Data recording sheet IV Compression Stage ________ Station compression machine 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) Method reference: As per In-process check procedure. Date : : : : : : : : : : : : : : : : 13 to 28 RPM NMT 15 minutes NMT 1. : xxxxxxxxxxxxxxxxx Rev.0% Prepared By Reviewed by Approved by Designation QA chemist Date Format No.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head .

/sq.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 25 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS 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 Average weight Thickness mm Hardness in kg. cm2 Friability in % DT in min.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. Weight variation after validated RPM __________ Time Average Weight Thickness Hardness Friability Disintegration Weight variation: Time Time Prepared By Time Time Reviewed by Time Approved by Designation QA chemist Date Format No. : xxxxxxxxxxxxxxxxx Rev.

:00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 26 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Remarks: Checked By: _________________________ Date: ____________________ Data recording sheet V Coating Stage Name of equipment Identification no Capacity Speed of coating pan Temperature of area Temperature of blower Spray rate Bed temperature Air Pressure Total coating solution used Weight build up Prepared By Weight of 20 Tablets Date : : : : : : : : : : : : Reviewed by Approved by Designation QA chemist Date Format No.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx Rev.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head .

: xxxxxxxxxxxxxxxxx Rev. weight variation and DT. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 27 of 33 : : : QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Average Weight of tablet Disintegration Time Dissolution (If required) Assay Method reference: As per In-process check procedure. Weight variation: Time Weight variation Remark: Checked By: _________________________ Prepared By Date: ____________________ Reviewed by Approved by Designation QA chemist Date Format No. At an interval of __ hours Date Time Initial weight Average weight Final weight Average weight % Weight gain DT in min.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head .xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. Not more than Plan: Coated tablets to be analyzed for Weight gain.

: xxxxxxxxxxxxxxxxx Rev. 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 Date : : : : : : : : Prepared By Reviewed by Approved by Designation QA chemist Date Format No. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 28 of 33 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) Method reference: As per In-process check procedure.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head .

1 5.2 5. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 29 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Data recording sheet VII Analysis Report Product Name: Batch No. Data recording sheet VIII Sr No 1 2 3 Name of critical equipment / Utilities Qualification / Validation file reference No Prepared By Reviewed by Approved by Date of Qualification / Validation Batch size: Exp.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.: Mfg. Date: Test method reference: In house Sr.3 5.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . Test 01 Description 02 03 04 05 5. : xxxxxxxxxxxxxxxxx Rev. No. Date: Composition: Specification Results Remark Designation QA chemist Date Format No.4 Remark: Result: The sample referred above complies / does not comply with the standard prescribed as per In house Specification.

: xxxxxxxxxxxxxxxxx Rev. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 30 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS 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 16 17 18 19 20 21 22 23 24 25 26 27 28 Utilities: 1 AHU System 2 Water System 3 Compressed Air 4 Steam 5 Lightning 6 Drain Prepared By Data recording Reviewed by sheet IX Production Manager Manager QC&A Approved by Designation QA chemist Date Format No.: xxxxxxxxxxxxxx Plant head .xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No.

:00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 31 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Remark: Analytical Method Validation protocol attached Prepared By Reviewed by Approved by Designation QA chemist Date Format No.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx Rev.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head .

0 to 4. No _____________ meets predefined acceptance criteria. Stage Sifting Premixing Stage Drying Lubrication Tablet compression Acceptance criteria No visible foreign particulate matter is observed Variation between the results shall not be more than 2% Between 2. : xxxxxxxxxxxxxxxxx Rev. weight. Tablets shall meet the requirements for weight gain. CONCLUSION REPORT Prepared By Reviewed by Approved by Designation QA chemist Date Format No. Approved By Date LIMITS: As pre relative STPs 8. Tablet Coated tablets shall meet FP Specification Packed tablet shall meet the requirement for leak test Observation packing Conclusion: Product _________________________________ manufactured as per B.M. 1. No. weight variation and disintegration. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 32 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Conclusion Sr. 3. 5.: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . Analysis By Date 7. 2. Tablets shall meet requirement of physical 6. 4.R. Tablet coating parameter and FP specification.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. 7.0% Variation between the results shall not be more than 2% Average weight of tablets is within ± ____of std.

disinfections and equipment sanitization. which clearly states the successful achievement of objective of validation studies and recommended concentrations required for sanitization. :00 Supersedes: NIL Protocol prepared on: xxxxxxxxxx Effective Date: xxxxxxxxxxxxx Page 33 of 33 QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR TABLETS Summary report will contain discussion and conclusion .: xxxxxxxxxxxxxx Production Manager Manager QC&A Plant head . Prepared By Reviewed by Approved by Designation QA chemist Date Format No.xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Protocol No. : xxxxxxxxxxxxxxxxx Rev. Note: Extra pages for conclusions can be used as per requirement.

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