(design Qualification) 1d4f4y

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

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VIBRO SIFTER GMP MODEL – 30”DIA. DESIGN QUALIFICATION

CLIENT

M/s. Milan Laboratories India Pvt. Ltd,

LOCATION

Panvel

YEAR OF MFG.

2009-2010

Allied MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT Unit No. 17, Param Industrial Estate, Naik Pada, Waliv, Vasai (East), District Thane- 401 208, Maharashtra, India. Fax: 0250 –: 2451675 Tel : 6451697, 6454301, 2451674 Email: [email protected]

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

TABLE OF CONTENTS 1.0

Pre-Approval

2.0

Overview 2.1 2.2 2.3 2.4

Purpose Responsibility Requalification System Description

2.5 3.0

Performance Qualification Procedure 3.1 3.2

Test procedures. Deficiency (if any) and corrective Action Report

4.0

Acceptance Criteria

5.0

Remarks (if any)

6.0

Summary 6.1 6.2 6.3

7.0

Conclusion Post –Approval

Appendix 7.1 7.2

Abbreviations List of documents

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MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

1.0

Pre-Approval

g of this Approval page of Performance Qualification Protocol No. 04 indicates agreement with the Performance Qualification approach described in this document. Should Modifications to the Performance Qualification become necessary; an addendum will be prepared and approved.

Written By

Signature

_______________________

Date S

(Manager - Project)

C Checked By

Signature

Date

Signature

Date

_______________________ (Manager - Engineering) _______________________ (Manager - Plant)

A Approved By ______________________________ (Sr. Manager – Quality Assurance)

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MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

2.0

Overview

2.1

Purpose: The purpose of this protocol is to provide an outline for the Performance of equipment for static attributes to that: ♦ Machine is performing as per functional requirement mention in design specifications.

2.2

Responsibility:

The validation group comprising of a representative from each of the following departments shall be responsible for the overall compliance with this protocol: ♦ Project Department ♦ Engineering Department ♦ Production Department ♦ Quality Assurance Department The Projects and Engineering Department shall be responsible for checking proper process validation and recording validation data as per the procedures outlined in this protocol. The Quality Assurance Department shall be responsible for the final review of the qualification documents and its compliance to meet the acceptance criteria of the Performance Qualification protocol. The summary report shall be approved by the head of Project, Engineering, Production and Quality Assurance.

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MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

2.3

Requalification: Performance Qualification to be re-qualified on: ♦ Replacement of major component of the equipment with a new component. ♦ Any major modification in the existing equipment. ♦ Any change in validation parameter. ♦ Shifting of the equipment from one location to another.

2.4

System Description Ribbon Blender is used for mixing dry or dump materials and used for tablet granulation. It consists of a 'U' shaped trough, solid SS end plates, SS shaft with specially designed paddles. The shaft is coupled with heavy duty gear box & motor. The shaft is ed on heavy duty bearing blocks at both the ends and provided with Teflon seals & stuffing box. Top cover is provided with SS grill structure for easy visibility during mixing operation. The motor- gear box assembly is completely covered in enclosure on/off push button box is provided with the machine with DOL starter. All SS parts are polished to mirror finish from inside mirror and outside parts are matt finished.

Salient Features • • •

Standard and GMP model with parts in SS 316 quality. Top cover with SS lid. Solid stainless steel end covers and frame work on the trough in even standard models for long trouble free life of the machine.

Technical specifications Model

BPE-VS-30

Main Motor

0.5 HP/1440, RPM FLP, Good Earth Make

Electrical Services

415 V/3 Phase, 50 Hz.AC Supply.

Output

100 Kgs./hr. or depend upon density of your product

Overall Dimension Height Width Length Net Weight

900 mm 900 mm 1200 mm 100 Kgs/hr.(Approx.–Depend upon density of powder) Page 5

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

3.0 3.1

Performance Qualification Procedure Test procedures. Output capacity Test Procedure

:-

Acceptance Criteria :-

Make all the initial setting of the machine to get desired capacity Machine should be capable of doing the set parameter

Output Quality Chart Sr.No Processed material at regular interval

Accepted

Rejected

Remarks:-

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MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

3.2

Deficiency (if any) and Corrective Action Report

If there is no deficiency, then write N. A. Description of deficiency and date observed : __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ Person, responsible for corrective action and date assigned: __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ Corrective actions taken and date conducted : __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ Conducted By : ___________________ Approved By : ___________________ Date

: ___________________ Date

: ___________________

Checked by (Project)

Name

Sign.

Date

Verified by (Engineering)

Name

Sign.

Date

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MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

4.0 Acceptance Criteria Performance Qualification shall be considered acceptable when all the

conditions

specified in various forms under section 3.0 have been met. Any deviation from the acceptance criteria of the specific check point shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment/component. 5.0

Remarks (if any) :

_________________________________________________________________________ _____________________________________________________________________ 6.0

Summary:

Checks Whether acceptance criteria of

Observations Yes/No

Remarks

the protocol and Specific check points are met. 6.1

Conclusion :

Mass Mixer bearing Mac No. ------ Is / Is Not qualifying the performance qualification test as per the guideline described in this Protocol No. 04 can Be / Not Be tested for its performance qualification. 6.2

Post-Approval Signatures

Name

Signature

Date

_________________________ (Manager – Project) _________________________ (Manager - Engineering) _________________________ (Manager - Plant) ___________________________ (Sr. Manager – Quality Assurance)

7.0

Appendix Page 8

MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

7.1

Abbreviations

7.2

List of Documents 1. M.O.C. of S.S. 316 & 304 Quality Material 2. Motor Certificate 3. Gasket Certificate 4. G.A. Drawing

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