Product Quality Review

An Overview

Jakarta, March 29th 2016

Ratna Sosialin
x of y
 PQR
Product Quality Review

Guidelines on GMP - Chapter 1 (Quality Management)

2
 PQR – Indonesia GMP (1.5)
Regular periodic or rolling quality reviews of all
licensed medicinal products,
products including export
only products, should be conducted with the
objective of verifying the consistency of the
existing process, the appropriateness of
current specifications for both starting materials
and finished products to highlight any trends
and to identify product and process
improvements. Such reviews should normally
be conducted and documented annually.
annually
3
 Product Quality Review
A regular periodic quality review
with objectives
j of:
1. Verifying the consistency of the process
Æ Process
P Robustness
R b t
2. Appropriateness
pp op ate ess oof Spec
Specifications
cat o s :
Æ Starting Materials
Æ Finished Products

highlight any trends to identify

product and process improvements

4
 PQR – Responsibility
RA
Manufacturing *

QA
Manufacturing/Plant * :
Production QC,
Production, QC
Procurement / PPIC /
Warehouse, Engineering,
General Services
Ser ices
(GMP related matters)

5
 Startting Materia
als

Bulk Production and

Packaging

QC L
Laboratorie
es

Ind. GMP - Quality

Stab
bility Studie
es

Chapter
PQR

Retu
urned Goods,
Produ
uct Complain
nts,
Assurance System Recalling
R
Points of Attention

M
Marketing
Autthorization

Mannufacturingg
Equipm
ment, Utilitties

Su
ummary of
Ev
valuation
1, Quality Management
PQR – Foundation & Pillars

6
 PQR - Starting Materials
01
Review of starting material and packaging material used
for the product, especially those from new source.

API`s,
API s, Excipients, Pack Materials

• Supplier Qualification – QAA (especially API`s)

API s)

• Deviation Control,, OOS

• Change Control

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 PQR - Bulk Production & Packaging

Review of critical In Process Control and

02
Finished product results.
results

Review of all batches that failed to meet

03 established specifications and their
investigations.

Review of all significant deviations or non-

04 conformances their related investigations,
conformances, investigations
and the effectiveness of resultant corrective
and preventative actions taken.

8
 PQR - Bulk Production & Packaging

Aspect Observation

Period of PQR
Deviations & Investigations (including OOS)

Rejection case
IPC (trending)

Yield (low case)

Status of Process Validation

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 PQR - Bulk Production & Packaging

• C
Critical
i i l IPC`s
IPC` and d Results
R l off Finished
Fi i h d Products
P d
All results of involved batches have been
reviewed and deviations are documented
documented.

Yes No
One or more In-Process-Controls show a trend
show no trend

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 PQR - Laboratories
05 Review of all changes carried out to the analytical methods

• Status of Analytical Method Validation

• Specifications
S ifi ti & Limits
Li it
• OOS cases
• Training and qualification of analysts
• Test Results (trends)

11
 PQR - Stability Studies
06
Review of the results of the stability
monitoring program and any adverse trends

Stability data (accelerated and long term)

• Trending
• Assigned shelf life and storage remark
yp
• Primary packing
g materials

• FUS (Follow Up Stability)

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 PQR – Returned Goods, Product Technica
Complaint & Recalling
Review of all quality-related returns, complaints,
07
recalls and the investigations performed at the time

• Trends of cases
• Deviation
D i ti Report
R t – (Root
(R t Cause
C Analysis
A l i / Investigation)
I ti ti )
Examples:
P d t Technical
Product T h i l Complaint
C l i t CAPA
- Under-filled boxes - Check weighing
- Double/ no leaflets - Sensor illumination

Remark:
In the case of facingg any
yq quality
y related p
problem leads to
recalling to notify Authority.
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 PQR - Marketing Authorization
08
Review of adequacy of any other previous product
process or equipment corrective actions

Scope:
- Validity of Marketing Authorization –
Renewal and any Change variation

- Primary pack and size

- Approved texts and lay out

- Assigned Shelf life & Storage Remark

- Registration Number

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 PQR – Manufacturing Equipment & Utilities

Qualification status of relevant equipment and utilities,

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e.g. HVAC, water, compressed gases, etc.

• Qualification status
• Maintenance and Calibration status
• Results of Monitoring/ trending
(HVAC, Purified Water, Gases, etc.)

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Example of Air Quality Monitoring

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 PQR – Summary of Evaluation

Conclusion & Recommendation, incl.

Statement:
• Process and product quality are appropriate

• Compliant to Marketing Authorization –

including
c ud g CChange
a ge Co
Control
t o ((if a
any).
y)

• Corrective & preventive Actions should be taken

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 PQR – Review of Critical Parameters

CONTROL CHART
• Statistical Analysis
• Trending
g
• Appropriateness of Limits

Data entry as soon as batch

disposition is carried out.

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 PQR – Process Performance of Batches

Is the process robust ?

Evaluate the performance of batches statistically

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Accuracy and Precision

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 Regulatory Compliance – MA

Objectives General
Requirement
Steps
p Each product is
Provide an assurance reviewed by
that commitment comparing its
described in Review the
compliance of current
Registration Dossiers manufacturing
f t i
are fulfilled when current
manufacturing practices and
releasing a batch for Registration
sale according to practices against
th Technical
the T h i l Part
P t Dossiers lead to
Marketing identify any gaps to
Authorization. of Registration
Dossiers. resolve.

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 Marketing Authorization Requirement
G
General
l Information
I f ti • Manufacturing
M f t i Site
Sit
• Product Description / Identification #
• MA Holder / Country
Registration Approval Registration Number Approval & Date
to manufacture Product (copy of approval)
CPP or Registration
g Approval
pp of • Copy
py of CPP
export market (Authority of • Copy of Registration Approval
Destination Country)
Reviews • Specifications & Test Methods of Starting Materials
• Specifications
S ifi ti &T
Testt Methods
M th d off Product
P d t
• Q/Q Formulation and Manufacturing Procedure
• Primary packing Materials
• Assigned Shelf Life
• Stability Study
• Storage Remark
• Printed Packing Materials

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