product quality review an overview - farmasi industri

Product Quality ReviewProduct Quality ReviewAn Overview

Jakarta, March 29th 2016Jakarta, March 29 2016

Ratna Sosialinx of y

FITHRUL FARMASIINDUSTRI.COM

PQR

Product Quality Review

Guidelines on GMP - Chapter 1 (Quality Management)

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PQR – Indonesia GMP (1.5)

Regular periodic or rolling quality reviews of alllicensed medicinal products including exportlicensed medicinal products, including exportonly products, should be conducted with theobjective of verifying the consistency of theobjective of verifying the consistency of theexisting process, the appropriateness ofcurrent specifications for both starting materialscurrent specifications for both starting materialsand finished products to highlight any trendsand to identify product and processand to identify product and processimprovements. Such reviews should normallybe conducted and documented annuallybe conducted and documented annually.

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Product Quality ReviewA regular periodic quality review with objectives of: j

1. Verifying the consistency of the process

P R b tProcess Robustness

2. Appropriateness of Specifications : pp op ate ess o Spec cat o sStarting MaterialsFinished Products

highlight any trends to identifyproduct and process improvements

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PQR – ResponsibilityR A

Manufacturing *

Q AManufacturing/Plant * : Production QCProduction, QC, Procurement / PPIC / Warehouse, Engineering, General Ser icesGeneral Services(GMP related matters)

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PQR – Foundation & PillarsPQR

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Quality Assurance SystemInd. GMP - Chapter 1, Quality Management

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PQR - Starting MaterialsReview of starting material and packaging material usedfor the product, especially those from new source.01

API`s, Excipients, Pack MaterialsAPI s, Excipients, Pack Materials

• Supplier Qualification QAA (especially API`s)• Supplier Qualification – QAA (especially API s)

• Deviation Control, OOS,

• Change Control

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PQR - Bulk Production & Packaging

Review of critical In Process Control and Finished product results

02Finished product results.

Review of all batches that failed to meetReview of all batches that failed to meet established specifications and their investigations.

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Review of all significant deviations or non-conformances their related investigations04 conformances, their related investigations,and the effectiveness of resultant correctiveand preventative actions taken.

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Aspect Observation

Period of PQRPeriod of PQRDeviations & Investigations (including OOS)

Rejection case

IPC (trending)

Yield (low case)

Status of Process Validation

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

Yes NoOne or more In-Process-Controls show a trend show no trend

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PQR - LaboratoriesReview of all changes carried out to the analytical methods05

• Status of Analytical Method Validation

S ifi ti & Li it• Specifications & Limits

• OOS casesOOS cases

• Training and qualification of analysts

• Test Results (trends)

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PQR - Stability StudiesReview of the results of the stability monitoring program and any adverse trends06

Stability data (accelerated and long term)

• Trending

• Assigned shelf life and storage remark

• Primary packing materials

• FUS (Follow Up Stability)

y p g

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PQR – Returned Goods, Product TechnicaComplaint & RecallingComplaint & Recalling

Review of all quality-related returns, complaints, recalls and the investigations performed at the time07

• Trends of casesD i ti R t (R t C A l i / I ti ti )• Deviation Report – (Root Cause Analysis / Investigation)

Examples:P d t T h i l C l i t CAPAProduct Technical Complaint CAPA- Under-filled boxes - Check weighing- Double/ no leaflets - Sensor illumination

Remark:In the case of facing any quality related problem leads to

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g y q y precalling to notify Authority.


PQR - Marketing AuthorizationReview of adequacy of any other previous product process or equipment corrective actions

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Scope:- Validity of Marketing Authorization –Validity of Marketing Authorization

Renewal and any Change variation

Primary pack and size- Primary pack and size

- Approved texts and lay out

- Assigned Shelf life & Storage Remark

- Registration NumberRegistration Number

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PQR – Manufacturing Equipment & Utilities

Qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc.09

• Qualification status• Maintenance and Calibration 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.Conclusion & Recommendation, incl.

Statement:• Process and product quality are appropriate

• Compliant to Marketing Authorization –

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

• Corrective & preventive Actions should be taken

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PQR – Review of Critical Parameters

CONTROL CHART• Statistical Analysis• Statistical Analysis

• Trendingg

• Appropriateness of Limits

Data entry as soon as batchData entry as soon as batch disposition is carried out.

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PQR – Process Performance of Batches

Is the process robust ?Is the process robust ?

Evaluate the performance of batches statistically

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Evaluate the performance of batches statistically


Accuracy and Precision

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Regulatory Compliance – MA

Objectives General Objectives

Provide an assurance Steps

RequirementEach product is

Provide an assurance that commitment described in Registration Dossiers

pReview the compliance of

reviewed by comparing its current

f t iRegistration Dossiers are fulfilled when releasing a batch for sale according to

current manufacturing practices against th T h i l P t

manufacturing practices and Registration Dossiers lead to

Marketing Authorization.

the Technical Part of Registration Dossiers.

Dossiers lead to identify any gaps to resolve.

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Marketing Authorization RequirementG l I f ti M f t i SitGeneral Information • Manufacturing Site

• Product Description / Identification #• MA Holder / Country

Registration Approvalto manufacture Product

Registration Number Approval & Date(copy of approval)

CPP or Registration Approval of • Copy of CPPg ppexport market (Authority of Destination Country)

py• Copy of Registration Approval

Reviews • Specifications & Test Methods of Starting MaterialsS ifi ti & T t M th d f P d t• Specifications & Test Methods of Product

• Q/Q Formulation and Manufacturing Procedure• Primary packing Materials• Assigned Shelf LifeAssigned Shelf Life• Stability Study• Storage Remark• Printed Packing Materials

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product quality review an overview - farmasi industri

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