IQ+OQ+PQ (3-in-1) Protocol. - Over 6.

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TEMPLATE FOR PROCESS VALIDATION PROTOCOL

Posted By: Pharmaceutical Guidanace on: March 27, 2016 In: Process Validation(PV) No Comments

TEMPLATE FOR  PROCESS VALIDATION PROTOCOL 

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                                                  CONTENTS 

Point No.       Section Title               Pages No. 

       NA Contents     01

       NA Protocol Approval Sheet    02

       1.0 Objective     03

       2.0 Scope     03

      3.0 Responsibility     03

       4.0 Validation Team Members     03

      5.0 Abbreviations    04

      6.0 Pre-requisite for Validation    04

      7.0 Manufacturing Procedure Under Validation    06

Critical Process Steps and Process Parameters for

      8.0    09
Validation with Justi cation

Process steps – Sampling and Analysis Plan with

      9.0    14
Acceptance Criteria 

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       10.0 Holding Studies   15

      11.0 Revalidation   19

      12.0 Deviations and Investigations   20

      13.0 Validation Report   20

      14.0 Reference Documents   20

      15.0 List of Annexes / formats Attached   20

   

 PROTOCOL APPROVAL SHEET              

Prepared by

Functional Area Name Designation Signature Date

Quality Assurance

                 

Checked by

Functional Area Name Designation Signature Date 

Production

Quality Assurance

     

Approved by

Functional Area Name Designation Signature Date 

R&D

Production

Quality Control

Quality Assurance

Objective

To provide documented evidence with high degree of assurance that the manufacturing process is capable of producing

the nished product consistently of required quality, meeting its predetermined speci cations and quality attributes.

Scope

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  This process validation protocol is applicable to carry out process validation of Name of the Product for rst three

consecutive commercial batches in view of the requirements of Name of market at formulation Plant of Pharmaceutical

Company.

Responsibility

Quality Assurance                                  :    Preparation, review and approval of process validation protocol.

Production                                             :    Production to approve the process validation protocol.

Quality Control                                      :    QC to approve the process validation protocol.

IPQA                                                    :    Sampling of samples as per the sampling plans

Discussed in this process validation protocol.

Engineering                                            : To provide support with respect to utilities and                                                                  

 equipment

Validation Team Members

Validation team shall comprise of the representatives from following functions:

Production

Quality Control

In-process Quality Assurance

Quality Assurance

Engineering

The validation team shall be authorized by Head-QA or his/her designee as per the format attached as Annexure

Abbreviations

Write the Abbreviations here.

Pre-requisites for Validation

Process Equipment

All equipment to be used for the manufacturing must be quali ed as per IQ/OQ/PQ acceptance criteria. The following

equipments are to be used for manufacturing of Name of the Product.

S.No. Equipment Name Process Step Equipment ID No. Processing Area

  Note: List of equipments used in the manufacturing process shall be prepared as per the format attached as Annexure.

Equipment / Instruments for In-process checks

The following calibrated equipment / Instruments shall be used for in-process checks.

S. No. Equipment /Instrument Name Equipment ID. No.

  

/
  

Documents

Following speci cations and Standard Test Procedures shall be referred for carrying out testing of validation samples.

         *Spec. No.                              *STP No.

(Granules stage)

(Uncoated tablets)  

       *Testing of samples shall be done as per current version of Spec., STP and GTP.

Approved Raw Materials

Information related to raw materials shall be recorded in Annexure.

Manufacturing Procedure Under Validation

Refer BMR: Manufacturing procedure: Master Formula No.

Manufacturing procedure in brief comprise of following steps:

Refer annexure for process ow chart.

Critical Process Steps and Process Parameters for Validation with Justi cation

      Process Step        Process Parameters                       Justi cation

   

Process Steps – Sampling and Analysis Plan with Acceptance Criteria

Sampling and Analysis Plan  with Acceptance

Process Step
Criteria

  Refer Annexure-

Holding Studies

Process Step Holding Studies Sampling and Analysis Plan with Justi cation

Write clearly Qnty of material to be kept under these studies, Frequency of sampling, test

Write the process stage parameter, packaging type, and area of storage, test method and acceptance criteria of

test method.


  

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 Revalidation

If required, revalidation shall be considered and carried out when any of the following conditions occur or prevail:

-Change in critical formulation component i.e. raw material

Change in manufacturer or vendor of Active Pharmaceutical Ingredient

Change in critical speci cations of the product

Change in manufacturing process which may a ect the quality of the products.

Change in the facility and /or plant (location or site)

Change in batch size, if more than ten times of the present batch size

Note:  In case of the requirements for revalidation, because of above mentioned            reasons, the validation of the critical steps

shall be undertaken through addendum protocol to this protocol or a separate protocol.

Deviations and Investigations

Any deviation to this protocol and thereupon investigation shall be recorded as per SOP

and investigation on out-of-speci cation test results shall be recorded as per SOP .

Validation Report

Based on the outcome from this validation study, a report shall be prepared by Quality Assurance persons. This validation

report shall be reviewed and then approved by all functional heads of all the concerned departments.

Reference Documents

In-process Speci cations (write the doc name)

Eur.

GTP No.:

List of Annexures / Formats Attached (the following documents are  written as annexure format during

protocol preparation )

Validation team  members                                           Annexure

Equipment list                                                           Annexure

Approved raw materials list                                         Annexure

Process ow chart                                                     Annexure

Critical process variables                                            Annexure

Sampling plan and analytical data compilation              Annexure

Environmental monitoring record (holding studies)         Annexure

Process validation report cover page                           Annexure

Process validation report approval sheet                      Annexure

Process validation report                                           Annexure

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