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Parenteral Process Validation 1

This 3-page document is a process validation protocol for parenterals. It outlines the purpose of process validation to consistently produce products meeting specifications. It lists responsibilities for preparation, analysis, review, and approval. Validation parameters include the formulation, product name, reason for validation, number of batches, and approval. The general introduction lists relevant documents. The process description provides an overview of steps including raw material dispensing, washing, sterilization, manufacturing, filtration, filling, sealing, inspection, and packing.
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50% found this document useful (2 votes)
1K views30 pages

Parenteral Process Validation 1

This 3-page document is a process validation protocol for parenterals. It outlines the purpose of process validation to consistently produce products meeting specifications. It lists responsibilities for preparation, analysis, review, and approval. Validation parameters include the formulation, product name, reason for validation, number of batches, and approval. The general introduction lists relevant documents. The process description provides an overview of steps including raw material dispensing, washing, sterilization, manufacturing, filtration, filling, sealing, inspection, and packing.
Copyright
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Protocol No.

:
Rev. :00
QUALITY ASSURANCE Supersedes: NIL
Protocol prepared on:
PROCESS VALIDATION PROTOCOL FOR PARENTERALS Effective Date:
Page 1 of 30

PROCESS
VALIDATION
PROTOCOL FOR PARENTERALS

Protocol No. :

Effective Date. :

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Designation
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Protocol prepared on:
PROCESS VALIDATION PROTOCOL FOR PARENTERALS Effective Date:
Page 2 of 30

TABLE OF CONTENTS

Page
S.NO. SECTION
No
1. Protocol approval

2. Purpose

3. Responsibilities

4. Requirements

5. Personnel Responsibilities

6. Validation parameters

7. Limits

8. Conclusion report

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1. PROTOCOL APPROVAL

This document is prepared by the validation and the GMP compliance (QA) team of ______________under the
authority of _____________. Hence this document before being effective shall be approved by
____________________.

Designation Name Signature Date

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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 Responsibility


1. Preparation of protocol
2. Chemical analysis and sampling
3. Microbial analysis & sampling
4. Preparation of validation Report
5. Review of validation protocol & report
6. Approval of protocol & Report

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.

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6. VALIDATION PARAMETERS:
Formulation: Parenterals
Product’s Name:
Reason for Performing the Validity Study:
Reason ( tick which ever is applicable) Remarks
Department
New product
Modification in the manufacturing process.
Change in Facility and / or location of manufacturing.
Batch fails to meet product & process specifications.

Number of batches studied: First Three Batches


Batch numbers: 1. ____________2.______________ 3._______________
Validation activity Approved by: _____________________________Date:_______________________

GENERAL:
Introduction:
The process validation will be performed as prospective validation. The complete documentation for the
validation comprises several independent documents; references to relevant documents will be given as part of
this protocol, (find below). The results of the validation activities will be summarized in the validation report.

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List of Documents for Validation:


 Validation protocol,
 Details of sampling for the validation batches, test parameters (Product performance characteristics) with
reference to test methods & Acceptance criteria. (acceptable Limit)
 Methods for recording / evaluating results including statistical analysis.
 Reference to relevant documents.
Batch manufacturing records.
 Detailed manufacturing instructions for the production of the validation batches.
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 checks in presence of QA person
4 De-cartoning of vials and rubber stoppers
5 Washing and Sterilization
5.1 vial washing
5.2 Sterilization of vials by DHS
5.3 Rubber stoppers washing
5.4 Steam heat sterilization of rubber stoppers, Garments and Machine parts.
6 Manufacturing/ Batch preparation
7 pH adjustment and volume makeup
8 Filtration
9 Vial filling
10 Lyophilization
11 Vials sealing
12 Optical inspections
13 Vials packing
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FLOW SHEET:
Prepare production order and according RM dispensing as per Bill of material
to that issue the BPR

Input check in presence of QA person De-cartooning

Manufacturing pH Adjustment and volume makeup

Filtration Washing and sterilization

Lyophilization Vials filling

Vials sealing Optical Inspections Vials packing

Sampling point

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FORMULATION:
Batch Size:
Sr No Quantity
Ingredients Unit per Quantity Overages with Dispensed Function
ml in Kgs Overages Quantity
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16

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Equipments/ Factory
A detailed list of equipment used for validation together with the cleaning status will be provided in the
manufacturing documents.
List of SOP’S, Validation & Qualification report used as references
SrNo Equipment Equipment No. SOP No
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17

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Page 10 of 30

DETAILS OF EQUIPMENT TO BE USED.

Equipment Details
Make/Model:
ID. No.
S.S. Manufacturing Tank Capacity:
Tag No.
RPM
M.O.C.
Model:
Rubber stopper washing ID. No.
Capacity:
machine
Tag No.
M.O.C.
Make/Model:
ID. No.
Vials washing machine Capacity:
Speed
Tag No.
M.O.C.
Make/Model:
DHS ID. No.
Capacity:
Tag No.
M.O.C.

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Equipment Details

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Make/Model:
Autoclave ID. No.
Capacity:
Tag No.
M.O.C.
Make/Model:
Membrane filter Capacity:
Tag No.
M.O.C.
Make/Model:
ID. No.
Capacity:
Filling Machine Tag No.
Speed
M.O.C.
Make/Model:
ID. No.
Lyophilizer Capacity:
Tag No.
M.O.C.

Equipment Details
Make/Model:

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ID. No.
Capacity:
Sealing Machine Speed
Tag No.
M.O.C.
Make/Model:
ID. No.
Labeling Machine Capacity:
Speed
Tag No.
M.O.C.
Make/Model:
ID. No.
Cold storage Capacity:
Tag No.
M.O.C.

Remarks:

____________________________________________________________________________________________

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IDENTIFICATION OF CRITICAL PROCESS VARIABLES PARAMETER:


Probable causes that may affect final product:

DISPENSING OF BATCH WASHING FILLING SEALING


MATERIAL PREPARATION

FINAL WASH
LOAD SIZE
LEAKAGE
ACTIVE SPEED
VOLUME SEALING

STIRRER

R.P.M. R.P.M.
CAKE
FORMATION
T MIXING
E TIME PH
M
P.

LYOPHILIZATION COLD STORAGE


ADDITION OF pH ADJUSTMENT
EXCIPEINT VOLUME MAKEUP

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Critical Process PARAMETERS:


Sr. No Critical process variable Response parameter Remarks
Fixed speed.
1 Batch Mixing time Uniformity
Fixed batch size
2 Final mixing and volume make up Uniformity of Active Drug Fixed speed.
Mixing time Fixed batch size
Rubber stopper washing
Detergent with heating Cleaning of rubber Clarity checking
3 Purified water stoppers
WFI washing
Siliconization Avoid the Clumping
Vial washing Fixed pressure for washing.
Purified Water pressure Cleaning Of vials Fixed temperature for washing
WFI Water temperature Fixed pressure of air
4 Compressed air pressure Fixed cycle
Washing cycle Washing efficiency Fixed direction
Alignment & blockage of needles
Fixed speed
Filling
5 Volume variation
Speed of filling machine Volume Uniformity
Leakage
6 Lyophilization Water content
Sealing Fixed speed
7 Speed of filling machine Volume variation
Volume Uniformity
Leak test Leakage
8 Optical inspection Clarity
Clean Label
Clean, Position & Proper
9 Labeling & Packing Sealing Position
Sealing

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Sampling, Test Parameters, Acceptance criteria

BOTTOM VALVE

Sampling site: - use bottom valve for Sampling


Sampling Qty.: -As per testing requirements.

Sampling Time: -
__________ minutes ____________minutes ________ minutes
Total samples:________

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SAMPLING:
Equipment
Stage / Test Parameter (Size, Location & Time) Acceptance Criteria
Manufacturing
pH Sampling  As specified in the BMR
Assay  Assay 90 % to 110 %

Vials washing Visual inspection, Inspected for particulate matter


Rubber stopper washing Visual inspection Inspected for particulate matter
Filling
Volume Measuring cylinder Not less than label claim.
Appearance Visual inspection, As specified in the BMR.
Colour Visual inspection As specified in the BMR
lyophilization lyophilizer As specified in the BMR

Sealing Leak test Complies leak test

Optical Inspections Vials checking Check clarity


Labeling & Packing Clean, Position & Proper Sealing Clean label and proper sealing

Note: The assay value should be decided based up the product in use. If it is biological take concerned
pharmacopeia and refer to the guidance values.(Especially in case of Fertility hormones).

Leak test and its methodology must be properly understood as per equipment used.
Optical Inspection: Refer to the guidance about visual inspection methodologies and Knapp test.

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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.

Data Recording Sheet No.


Sheet No 1 For recording batch preparation & results
Sheet No 2 For recording of vial washing and sterilization results
Sheet No 3 For recording of Rubber stopper washing and sterilization results
Sheet No 4 For recording Filtration Details
Sheet No 5 For recording of vial filling
Sheet No 6 For recording of lyophilization
Sheet No 7 For recording of vial sealing
Sheet No 8 For recording of labeling and packing
Sheet No 9 For recording of analysis report
Sheet No 10 For recording general utilities /equipment.
Sheet No 11 For recording analytical method validation.

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Data recording sheet -1


Batch preparation:
Equipment name : _______________________
Identification no : _______________________
Date :____________________
Capacity : ______________________ltrs / gms.
Ingredients and sequence of material addition: ____________________
Total Volume of ingredients : _______________ ltrs/gms.
Mixing time : _______ minutes
Stirrer : _______rpm
Procedure : As outlined in the batch manufacturing record.
Plan : Samples to be drawn at of _______ minutes, _______ minutes, &
______ minutes of mixing from sampling point
For batch preparation result:
Assay after mixing
pH Weight per ml Assay
Time
______Minutes
______Minutes
______Minutes
Mean

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Note: pH meter calibration is essential.

Data recording -2
Equipment Name : vial washing Machine
Identification no : _________________________ Date: ___________________
Capacity : ______________________ (vials per minutes)
Method reference: Visual inspection.

Observation: Washed vials shall be inspected for particulate matter.

Stage Inspected by 1 2 3 4 5 6 7 8 9 10
Beginning of washing
Middle of washing
End of washing

Conclusion:

___________________________________________________________________________________________

Note: If you have a procedure or methodology to remove the vials as per non-conformity attach a table how
many vials were fed and how many were removed. This is a key point to track the vials quality and report to
your vendor. More than 0.3% of rejections is considered very high.

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Data recording -3
Equipment Name: Rubber stopper washing Machine
Identification no : _________________________ Date: ___________________
Capacity : ______________________
Method reference: Visual inspection.

Observation: Washed Rubber stoppers shall be inspected for particulate matter.

Stage Inspected by 1 2 3 4 5 6 7 8 9 10
After washing

Conclusion:

_________________________________________________________________________________________

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Data recording 4

Filtration Parameters:
Type of Filter used and Its manufacturer:________________
Membrane filter holder or Cartridge housing number:________
Nitrogen gas or a Pump :________________
Details about sanitization of Pump if it is used:_____________
Integrity check details of Nitrogen filter:_____________
Capacity of Pressure vessel used:_________
Details of pressure vessel :____________

Pressure at which the Filtration is Performed:____________


Results of Pre and Post Integrity tests:_______ & ___________.
Filtration is Pass/ Fail.

Note: Always use a validated and calibrated integrity testing apparatus

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Data recording 5
Equipment Name: Filling machine
Identification no: ________________________________
Machine Speed: _________________________________
Standard volume: ________________________________

Procedure: As per In-process check procedure for volume check.

Observation: Volume shall be as per the limit.

Plan: Samples to be drawn from beginning of filling, middle of filling and end of filling (Depends upon batch size)

Inspected
Stage Volume measured in measuring Cylinder by
1 2 3 4 5 6 7 8
Beginning of
filling
Middle of filling
End of filling

Conclusion:
____________________________________________________________________________________________

Checked by: ___________________________ Date_________________________

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Data recording -6
Equipment Name: Lyophilization
Identification no: ________________________________
Machine Capacity: ________________________________
Procedure: Filled vials send to the lyophilizer for lyophilization process.

SAMPLING: Sampling should be done after the competition of the lyophilization cycle and check all
Parameters mentioned in BPR

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Data recording -7

Equipment Name: Sealing machine


Identification no: ________________________________
Machine Speed: _________________________________
Procedure: As per In-process check procedure for sealing check

Observation: Sealing should be proper.

Plan: Samples to be drawn from beginning of filling, middle of filling and end of filling (Depends upon batch size)

Inspected
Stage Leak test Remarks by
1 2 3 4 5 6 7 8
Beginning of
Sealing
Middle of
sealing
End of sealing

Conclusion:

Checked by: ___________________________ Date_________________________

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Data recording -8
Equipment Name: vial labeling machine
Identification no: ________________________________
Machine Speed: ________________________________
Procedure: Labeling should be as per the specifications.

Method reference: Leak test procedure for Sealed vials.

Stage No of vials tested Position of label


After machine Setting
Beginning of Setting
Middle of Setting
At the end of Setting

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Data recording-10
Analysis Report

Product Name:
Batch No.: Batch size:
Mfg. Date: Exp. Date:

Composition:
Test method reference: In house
Sr. No.
Test Specification Results Remark
01 Description
02 pH
03 Specific Gravity
04 Uniformity Of volume
05 Assay
5.1 % Labeled amount: 90 % - 110 %
Quantity Found:
5.2 % Labeled amount: 90 % - 110 %
Quantity Found:
5.3 % Labeled amount: 90 % - 110 %
Quantity Found:
5.4 % Labeled amount: 90 % - 110 %
Quantity Found:

Remark:
Result: The sample referred above complies / does not comply with the standard prescribed as per In house
Specification.

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Data recording 10

Sr Name of critical equipment / Utilities Qualification / Date of Qualification /


No Validation file Validation
reference No
1 S.S. Manufacturing tank
3 Membrane Filter
4 Filtration tank
5 Washing Machine
6 Filling Machine
7 Lyophilization
8 Sealing Machine
9 Labeling Machine

Utilities:
1 AHU System
2 Water System
3 Compressed Air
4 Steam
5 Lightning
6 Drain

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Data recording 11

Remark:
Attach Analytical Method Validation protocol

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Conclusion
Sr. No. Stage Acceptance criteria Observation
1. Manufacturing Complies as per BPR
2. Vial Washing Complies as per BPR
3. Rubber stopper
washing Complies as per BPR
4. Filling Complies as per BPR
5. Lyophilization Complies as per BPR
6. Sealing Leak test
7. Labeling and
packing Complies as per BPR

Conclusion:
Product _______________________manufactured as per B.M.R. No _____________ meets predefined
acceptance criteria.

Analysis By Approved By

Date Date

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7. LIMIT: Based on respective Standard Testing Procedures.

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 sanitisation, disinfections and
equipment sanitization.

Note: Extra pages for conclusions can be used as per requirement.

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