Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-

Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

PERFORMANCE QUALIFICATION
PROTOCOL
FOR
COLLOID MILL MACHINE GMP
MODAL- WATER JACKETED-
HORIZONTAL
EQUIPMENT ID:

Revision Date Reason for revision

00 New Protocol has been prepared for Performance Qualification

Contents

Page 1 of 12
Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

Sr. No. Title Page No.

1.0 Pre-Approval 03
2.0 Objective 04
3.0 Scope 04
4.0 Responsibility 05
5.0 System description 07
6.0 Pre-qualification requirements 08
7.0 Test and checks 09-12
8.0 Acceptance Criteria 08
9.0 Reference 09
10.0 Documents to be attached 09
11.0 Non compliance 09
12.0 Deviation from Pre- define specification if any 10
13.0 Change control, if any 10
14.0 Abbreviations 10

Page 2 of 12
 Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

1.0 Report Pre- Approval:

Signing of this Performance Qualification protocol of Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal indicates an agreement with the performance qualification approach of Colloid Mill Machine
GMP Modal- Water Jacketed- Horizontal in Production Department of Pvt. Ltd. If any
modification to this becomes necessary an addendum shall be prepared and duly approved.

Prepared By:
Name and Functional area Signature Date

Quality Assurance

Reviewed By:

Name and Functional area Signature Date

Production Manager

QC Manager

Engineering Manager

Approved By:
Name and Functional area Signature Date

Quality Assurance

Page 3 of 12
Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

2.0 Objective:
The purpose of carrying out Performance Qualification protocol of Colloid Mill Machine GMP Modal-
Water Jacketed- Horizontal is to establish documented evidence that the system performance is in
accordance with the predefined specifications.

3.0 Scope:
The document includes the Performance Qualification procedure of the following system:

Name of the equipment Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Equipment identification number CV/

Supplier Name and address

Website: www.saimach.com

Facility General Formulation Facility

Floor Ground floor

Room name & number Coating Area

This report should be generated to qualify the initial performance of the system. In case of any deviation
observed during qualification same shall be log as per deviation SOP.

Page 4 of 12
Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

4.0 Responsibility:

Department Responsibility

 Preparation, Review, Approval and Compilation of the Performance

Qualification Document.
Quality Assurance  Co-ordination with Quality Control, Production and Engineering to
carryout Performance Qualification Protocol Activity.
 Monitoring of Performance Qualification Protocol Activity.

 Review of Protocol
Production
 To Co-ordination and support Performance Qualification Activity.

 Review of Protocol
Quality Control
 To Co-ordination and support Performance Qualification Activity.

 Review of Protocol
Engineering
 To Co-ordination and support Performance Qualification Activity.

Page 5 of 12
Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

5.0 Training Attendance Sheet:

Sr. Trainee Sign & Trainer Sign &

Employee Name Emp. Code Evaluation
No. Date Date

Page 6 of 12
Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

Page 7 of 12
Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

6.0 System Description:

This equipment is a self contained a portable unit for the process of size reduction. It used the principle of
impact in Air. The product is dropped axially from the feed hopper. In a communication chamber where it
comes in contact with blades (Either the knife edge or the impact edge) rotating at high speed.
Operating speed are variable & can be varied in steps of 750/1500/2100/3000 by a simple & design of
placing the “V” belt in the desired groove of a multi groove pulley.
Operating parts can be dismantled & assembled quickly, thereby saving down time during cleaning.
A safety limit switch can be incorporated in the top cover so as to switch off the equipment as soon as the
cover is opened (optical).
Screen range from
Perforated 0.5 mm to 25 mm in S.S. 316/304 quality.
Wire mesh with backup frame-4 mesh to 80 mesh in S.S. 316/304 quality.
Special Hollander weave screen of 110/24 mesh in S.S. 316/304 qualities.

7.0 Reason for Qualification:

 New equipment installed in Coating Area.
 After completion of the successfully Operation Qualification of the Equipment, it is imperative to perform
the performance qualification. The study will establish that the parameters area followed, critical variable
are under control and the quality of the output is, as desired.

8.0 Frequency of Qualification:

 Once in every Five Year.
 After any major breakdown or after major modification.

Page 8 of 12
Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

9.0 Pre Qualification Requirements:

The results of any test should meet the limits and acceptance criteria specified in the test documents. Any
deviations or issues should be rectified and documented prior to PQ commencing.

9.1 System pre-requisites:

 Verification for availability, completeness and approval status of all the required relevant documents shall
be done and observations shall be recorded in the performance qualification report.
Verified By
Sr. Completed
Documents No. (QA)
Documents Name (Yes/No)
No. Sign & Date
1.
DQ Documents
2.
IQ Documents
3.
OQ Documents

4.
PQ Protocol

5. SOP for Operation & Cleaning of

Colloid Mill Machine

6. SOP for preventive Maintenance of

Colloid Mill Machine

Page 9 of 12
Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

10.0 Test and Checks:

10.1 Performance Evaluation Using Drug Product:
 To verify the performance of equipment in the range of operational parameters established in Operational
Qualification Activity.
 To establish documents evidence that the Colloid Mill Machine GMP Modal- Water Jacketed- Horizontal
is performing consistently and the result of all test parameters meet the pre-defined acceptance criteria of
products.
10.1.1 Purpose:
The objective of this test is to ascertain an approved particle size of the dispensed/ milled powder
for the coating process.

10.1.2 Method:
Install/ ensure mesh of size as identified in BMR. Mesh opening of the Sieve to be as identified
as per SBB Mesh number.
The dispensed/ milled material is charged through scooping into the hopper of the colloidal mill.
The quantity & type of material charged and the size of the sieve selected shall be as per BMR.
The sieving is carried out as per approved parameters, in accordance with Standard Operating
Procedure & as per BMR.
Samples of milled material are taken at the high, middle & slow speed of the milling process
from the discharged chute of the colloidal mill.
The samples are analyzed for appearance and particle size by manual sieving through as
analytical sieve of approved mesh size.

10.1.3 Acceptance Criteria:

Granules of the respective size are passes through the respective mesh.

Page 10 of 12
Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

10.1.4 Checklist of all Tests & Checks:

A checklist shall be provided to ensure that all tests or checks required for this protocol have
been executed. After execution observations shall be recorded in Performance Qualification
Report.
 Verification of DQ, ID, OQ and other documents.
 Verification of performance using Drug product.

11.0 Reference:
 Validation Master Plan
 Schedule-M- “Good Manufacturing Practices and Requirements of Premises, Plant Equipment for
Pharmaceutical Products”.
 WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol-2 Good Manufacturing
Practices and Inspection.

12.0 Documents to be attached :

 Any other Relevant Documents.
 Operation and Maintenance Manual.

13.0 Non Compliance:

 In case of any deviation observed during PQ, inform to Head QA for necessary action.
 Document the deviation detail in observed deviation section.
 The Head QA shall study the impact of deviation. If deviation is acceptable and it does not have an
impact on operation as well as on performance of the machine, prepare final conclusion.

Page 11 of 12
Document Name: Performance Qualification Protocol for Colloid Mill Machine GMP Modal- Water Jacketed-
Horizontal
Identification Number: Document Number:
Effective Date: Revision No.:

14.0 Deviation from Pre- define specification if any:

 All deviations, non conformance and out of specification results obtained shall be investigated in
accordance with corresponding SOPs and documented in the qualification report.

15.0 Change Control, If any:

 Details of change control initiated during qualification activity shall be documented in the qualification
report.

16.0 Abbreviation:
WHO : World Health Organization
cGMP : Current Good Manufacturing Practices
PQ : Performance Qualification
RMG : Rapid Mixture Granulator
GMP : Good Manufacturing Practices
QA : Quality Assurance
PLC : Programmable Logic Control

Page 12 of 12