TEM-295

Issue date
Process Validation Interim / Final Report
(Reference: SOP _____)

[Enter Product Title, Number & Strength]

PRODUCT CODE:

WRITTEN BY: REVIEWED BY:

Name:
Signature:
Position:
Date:

Qualification Status
Qualification of [enter raw material item description, item code] as per protocol [enter protocol
no] has been completed for the following:

• [enter product name, code and lot no]

All deviations and additional protocol results for the batch are documented in this interim
report. All acceptance criteria have been met according to protocol [enter protocol no] and all
deviations resolved.

The qualification for the use of [enter raw material item description, item code] in the
manufacture of enter product name, code and lot no] has been successfully completed.

• The qualification status of the use of enter raw material item description, item code] in
the manufacture of [enter product name, code and lot no] remains on-going until all
qualification data has been compiled for this study and will be documented in a subsequent
report.

REPORT COMPLETION APPROVAL:

Name: [Type Name] [Type Name] [Type Name]
Signature:
Position: Validation Manager Production Officer QA Team-Leader
Date:

1. OBJECTIVE
The objective of this interim report is to document the process results and process
parameters obtained during the manufacture of [enter blend/granulate name and batch
number] and [enter Cap/Tab product name and batch number] in the Manufacturing facility at
[enter site name].

The [enter blend/granulate name and batch number] is the [first/second/third] validation blend
in this study manufactured for the Local market. The [enter Cap/Tab product name and batch
number] is the [first/second/third] run of three validation batches to be manufactured for the
[Local /export] markets. Refer to table 1.0 below for details on all the validation runs covered
in this report and from previous interim reports. A statistical review of these processes is

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 TEM-295
Issue date
Process Validation Interim / Final Report
(Reference: SOP _____)
6. VALIDATION STRATEGY

The manufacturing process of [enter blend name] (commercial lot size in kg) and [enter product
caps/tab] (enter batch size or commercial batch size may depend on market demand) were
validated under the control of the Technical Services Department. [Enter for both export and Local
if applicable].

A [concurrent/prospective/retrospective] validation approach was used for this validation study.

Justify concurrent e.g. because some of the [enter product name] dosages are not manufactured
very frequently in the Manufacturing facility at [enter site name].

All validation batches were manufactured following the same manufacturing process as detailed in
the manufacturing instructions [give Manufacturing Instruction number and current versus protocol
version number/date].

All critical process variables in the manufacturing process [blending/granulation and

tabletting/encapsulation] were reviewed. [These/this] validation [batch/es] were analysed as set
out in [enter section reference] of the protocol [enter protocol number] and the results are
summarised in [enter Section reference] of this report.

This report will document the number of blend / granulate samples from the run e.g. minimum of 10
locations from the blender to show blend uniformity/homogeneity [dead spot characterisation in
modified processes only, reference [enter no] and Blend sampling strategy report [enter no]. NIR
blend analysis will be run on all blend samples to assess blend uniformity.

In-process testing - use what is applicable:

The NIR analysis performed throughout this run is [e.g. 6 capsules/ tablets each hour throughout
the run] is documented in this report OR NIR analysis was run on 10 capsules at the following time
points:
• the first 10 capslues/tablets from the start of the encapsulation / tabletting process,
• from a composite* sample of 20 dosages from each bucket throughout the run
• Critical Time Points – first 10 capsules / tablets off the machine, after the event.
Examples of Critical Time Points are as follows; major break down of tablet machine,
after an extended break in [tabletting/encapsulation] (i.e. outside normal operational
stops & starts), blockages
• the last 10 capsules/tablets off the machine

The potency of the unit dosage with both the highest and lowest absorbance from the NIR scans
over the entire run was analysed for potency by the QC Lab to equate the absorbance to the actual
concentration. The results are documented in Section XXX of this report.

In-process weight results and statistical analysis performed to identify the state of process control
are documented in this report in Section XXX.

This report documents the sampling and testing required and performed on the finished product.
Full product testing on the routine end – of the – run sample of tablets / capsules was required
apart from Dissolution, Assay and Content Uniformity which were required to be tested on the
additional validation samples. The additional validation samples, taken from 7 different time points
distributed throughout the validation run, include start, middle and end or run. Assay and Content
Uniformity testing were required on 70 tablets / capsules (10 capsules from each time point) and
[Comparative] Dissolution testing was required on 12 [or 6 if only dissolution profile] capsules from
the end – of the – run sample. The Comparative Dissolution profile is required to be performed on
3 batches of the current process and compared to each validation batch [if applicable]. This report
documents the fist comparison dissolution profile.

Process Validation the following 2 paragraphs are applicable:

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 TEM-295
Issue date
Process Validation Interim / Final Report
(Reference: SOP _____)
Encapsulation Encapsulation of Enter parameter Critical/ Non critical
the blend into Enter parameter Critical/ Non critical
tablets / capsules Enter parameter Critical/ Non critical
Enter parameter Critical/ Non critical

The machine settings and ranges listed in Table 7.3.2.2 below were identified as being the
Normal Operating settings / ranges in protocol [enter protocol number]. Te following operating
ranges are allowed for these parameters and the actual settings used for the validation batch
were recorded in [enter protocol Appendix number].

Table 7.3.2.2: The Actual Tabletting / Encapsulation settings guides used

Parameter Dosage Dosage

Enter Enter set point / range Enter set point / range

parameter
Enter Enter set point / range Enter set point / range
parameter
Enter Enter set point / range Enter set point / range
parameter
Enter Enter set point / range Enter set point / range
parameter
Enter Enter set point / range Enter set point / range
parameter

7.4 Equipment Used – Validation Status

Table 7.4.1: Equipment used in the manufacture and testing of [enter product name]

Process Equipment Equipment # Validation Validation

Step Status Reference
Enter process Enter piece of equipment Equip. Validated / Enter report reference
step number Incomplete /
legacy
Enter process Enter piece of equipment Equip. Validated / Enter report reference
step number Incomplete /
legacy
Enter process Enter piece of equipment Equip. Validated / Enter report reference
step number Incomplete /
legacy
Enter process Enter piece of equipment Equip. Validated / Enter report reference
step number Incomplete /
legacy
Enter process Enter piece of equipment Equip. Validated / Enter report reference
step number Incomplete /
legacy
Enter process Enter piece of equipment Equip. Validated / Enter report reference
step number Incomplete /
legacy

All equipment is in a validated state [with the following exceptions if there are any]. If any
exceptions refer to Deviation # in Section # of this report and the deviation log in Appendix # of the
protocol.

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 TEM-295
Issue date
Process Validation Interim / Final Report
(Reference: SOP _____)

The Control limits generated for the process above is based on the combined 30 sample data
from each batch. To visualise the between batch variation the 30 data points from each batch
should have separate control limits to show uniformity.

9.3 Final Blend Release test results

The Table 9.3.1 below details the release blend test results for [enter product name and lot
number]. All release blend testing specifications have been met. Refer to [enter Appendix number]
of this report for product results.

Table 9.3.1 – Release Blend Results for [enter batch number]

Test Name Specification Test Method [enter batch number]

Enter test Enter specification Enter test method Enter result
name number number
Enter test Enter specification Enter test method Enter result
name number number
Enter test Enter specification Enter test method Enter result
name number number
Enter test Enter specification Enter test method Enter result
name number number
Entered by: Date:
Transcription Verified by: Date:
[Refer to where data is attached].
All validation assay test results and release blend test results meet their required specifications.
The blend assay results for lot [enter lot number] are considered acceptable.

9.4 Final Blend Physical Test Results

9.4.1 Analysis of [enter lot number]

A composite sample of the final blend for [enter lot number] was tested for particle size distribution
as per test methods [enter test method/s] respectively. This data was taken for information
purposes and will be compared to the next scheduled validation batch. Refer to Technical
services Request ID No. [enter number if applicable] in [enter Appendix number] of this report for
Physical results. This batch is compared here to the previous validation batch [enter batch
number].

Table 9.4.1.1 – Carr’s Index and Hausner Ratio of final blend [enter lot number] versus
previous validation [batch/es and enter lot number] (if available)

Batch Number Bulk Density Bulk Density Carr’s Index Hausner Ratio
As is (ml/g) Tapped (ml/g)
Enter batch Enter result Enter result Enter result Enter result
number
Enter previous Enter result Enter result Enter result Enter result
batch number
Entered by: Date:
Transcription Verified by: Date:
[enter reference to calculations in workbook]

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