MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT
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VIBRO SIFTER GMP MODEL – 30”DIA. DESIGN QUALIFICATION 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 2451675 Tel : 6451697, 6451697, 6454301, 2451674 Email:
[email protected]
MANUFACTURES OF PAH RMACEUTICAL RMACEUTICAL EQUIPMENT
TABLE OF CONTENTS
1.0
Pre-Approval
2.0
Overview 2.1 2.2 2.3 2.4
Purpose Responsibility Requalification System De Description
2.5 3.0 3.0
Perf Perfor orma manc nce e Qual Qualif ific icat atio ion n Proc Proced edur ure e 3.1 3.2 3.2
Test pr procedures. Defi Defici cien ency cy (if (if any any)) and and corr correc ecti tive ve Act Actio ion n Repo Report rt
4.0
Acceptance Criteria
5.0
Remarks (if any)
6.0
Summary 6.1 6.2 6.3
7.0
Conclusion Post –A –Approval
Appendix 7.1 7.2
Abbreviations List of do documents
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MANUFACTURES OF PAH RMACEUTICAL RMACEUTICAL EQUIPMENT
1.0
Pre-Approval
Signing Signing of this Approva Approvall page page of Perform Performanc ance e Qualific Qualificatio ation n Protoco Protocoll No. 04 indicat indicates es 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 PAH RMACEUTICAL RMACEUTICAL EQUIPMENT
2.0
Overview
2.1
Purpose:
The The purp purpos ose e of this this prot protoc ocol ol is to prov provid ide e an outl outlin ine e for for the the Perf Perfor orma manc nce e of equipment for static attributes to verify that: ♦
Machin Machine e is perfo perform rming ing as per per functi function onal al requir requirem ement ent ment mention ion in desig design n
specifications.
2.2
Responsibility:
The validation group comprising of a representative representative from each of the following departments 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 PAH RMACEUTICAL RMACEUTICAL EQUIPMENT
2.3
Requalification: Performance Qualification to be re-qualified on:
2.4
♦
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.
System De 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 supported 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 contact 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 PAH RMACEUTICAL RMACEUTICAL EQUIPMENT
3.0
3.1
Performance Qualification Procedure
Test pr procedures. Output capacity Test Proce Procedur dure e
Acceptance Criteria :-
:-
Make Make all all the the initi initial al sett setting ing of the mach machine ine to get desir desired ed capacity Machine should be capable of doing the set parameter
Output Quality Chart Sr.N Sr.No o Proc Proces esse sed d mate materi rial al at at regular interval
Accepted
Rejected
Remarks:-
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MANUFACTURES OF PAH RMACEUTICAL RMACEUTICAL EQUIPMENT
3.2
Defic Deficien iency cy (if any) any) and and Corre Correcti ctive ve Actio Action n Report 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 PAH RMACEUTICAL RMACEUTICAL 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 6.2
Post-Ap -Approv roval Signatures res
Name
Signature
Date
_________________________ (Manager – Project) _________________________ (Manager - Engineering) _________________________ (Manager - Plant) ___________________________ (Sr. Manager – Quality Assurance)
7.0
Appendix Page 8
MANUFACTURES OF PAH RMACEUTICAL RMACEUTICAL EQUIPMENT
7.1
Abbreviations
7.2
List of of Do Documents 1. M.O.C. M.O.C. of S.S. S.S. 316 & 304 Quali Quality ty Materi Material al 2. Moto Motorr Cert Certif ific icat ate e 3. Gask Gasket et Cert Certif ific icat ate e 4. G.A. .A. Dra Draw wing ing
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