Installation Qualification (IQ) PROTOCOL

Instrument Series Bosch

Model GKF 2000 S

Instrument Automatic Hard Gelatin Capsule Filling Machine

Description
Service Contact +41586748811
Serial Number 800164MS2009W
Condition When New
Supply
Date 2002

Installed Location No. 21, Jalan Juruukur U1/19,

Hicom-Glenmarie Industrial Park,
40150 Shah Alam, Selangor, Malaysia.

Purchase Order PO/2012-027

Number
Invoice Number I-20120070

Test Conducted by Bosch Packaging Services AG

Vendor
Test Verify by Phytes Biotek Sdn Bhd
Customer
Test Location Phytes Biotek Sdn Bhd

SIGNATURE SIGNATURE
CONDUCTED BY CONDUCTED BY
DATE DATE
 Pre-approval
Documentation for
Installation Qualification and Operational Qualification

Pre-Approval
This document is the combined protocol and report record for the Installation Qualification of
the equipment, to be executed at manufacturers premises under the supervision of customer’s
personnel. The signatures below of PHYTES BIOTEK SDN. BHD.’s personnel indicate that
the contents of these protocols have been reviewed and meet design and functional
specifications and capture user’s intended use of the equipment.
In the case or Quality Assurance, the signature below indicates review and approval of the
protocols. When all signatures have been entered on this review and approval page, the
protocols are approved for the execution.

Reviewed by:
PHYTES BIOTEK SDN BHD
DEPARTMEN NAM DESIGNATIO SIGNATUR
T E N DATE E
         
         
         
         
         
General Procedure
In general, test methods are to be executed in the order presented, however the test executors
can decide the actual order to optimize test execution. All data are to be recorded using
permanent ink or ball pens (BLUE), on the data sheets provided. Any comments or additional
test data should be recorded on the appropriate data sheet. Multiple copies of some data
sheets may be required. Any additional comments should be signed and data by their
author(s).
After the completion of each test section, the data generated will be evaluated. In the event
that a result does not conform to an acceptance criterion specified in the protocol, a
deficiency report shall be issued by the appropriate individuals to investigate the situation and
a corresponding action will be taken.
The validation protocol is divided into sections. The failure of one section to comply with
validation criteria does not necessarily provide a basis for the failure of any other sections.

IQ Test 1: Verification of Operational Manual

Test Procedure
Verify the machine Operational Manual is available

Acceptance Criteria
Document such as spare part list, drawing and diagram must be listed out.