GDP OF MEDICAL DEVICES –RISK BASED APPROACH

Sateesh Yelisetti

ACCSQ-MDPWG , KL

April 23, 2013

AGENDA

• Comprehensive approach towards GDP of MDD

•Complying to regulations

•Management of Value Added Services

GDP

Good Distribution Practices (GDP) is a quality system forwarehouse and distribution centers dedicated for Drugs/Devices.Internationally accepted Healthcare GDP regulations stipulate thatdistributors of Healthcare products must align their operations withthe standards. The scheme ensures that consistent qualitymanagement systems are in place throughout entire supply chain.

Maintaining product safety and quality during distribution is of utmost importance in the Healthcare industry.

COMPREHENSIVE APPROACH

1. Map the products and process

2. Identify the risks

3. Make Control plan

4. Monitoring Mechanisms

Personnel

Premises &

Facilities

Stock

Handling

& Control

Document-

ation

Quality Actions

Discard

&

Returns

Audits

COMPREHENSIVE APPROACH

Safe Device

Value Added Services

Manufacturing

Import/Export

1st level distribution

Distribution Center

2nd level distribution

B2B & B2C distribution

End users

Repacking/

kitting Center

Freight forwarding/

Customs clearance

Distribution

Center

Management

Transportation

Management

In Store

logistics

Reverse LogisticsEnd user

Distribution

E-commerce

Service

Inventory

Management /

Replenishment

Package/

Labelling

ALL ABOUT GDP

Repair/

Service/

Installation

HIGH RISK AREAS

• Labeling

•Cold Chain Management

•Discards & Returns Management

•Equipments & Instruments

•Kitting/Assembly

•Counterfeiting

HIGH RISK AREAS- LABELING

• Clearly documented SOP

•List the part numbers

•Specification of labels

•Version Controls & Approvals

•Master list

•Batch Record Review and Release

HIGH RISK AREAS – COLD CHAIN MANAGEMENT

Cold Chain Products Management• Storage Assurance• Handling

• Writing an SOP and clearly defining the requirements that can allow the acceptance of returns for stocking and sale .• Records for storage within the specified temperatures• How the goods are packed and returned• Validations• Verifications

Note: In general the cold chain product returns are discarded due to risks involved

HIGH RISK AREAS – DISCARDS & RETURNS MANAGEMENT

Clarity of Acceptance Criteria to differentiate Saleable and Non-saleable goods

• Need to write to a detailed SOP clearly explaining the acceptance criteria and implementing it effectively

• Guides/Manuals with examples and illustrations

• Periodic Training and updates

•Metrics monitoring

HIGH RISK AREAS -EQUIPMENTS & INSTRUMENTS

Equipment:•Certain Medical Equipment requires Installation/Service and

Repair Centre

•Robust procedures required to handle these activities

•Special conditions/Test Labs

HIGH RISK AREAS – EQUIPMENTS &

INSTRUMENTS

Instruments:

•Reusable Instruments cleaning

•Disassembly and high level disinfection

•Validated methods and procedures to ensure

cleaning

•Sterilization in certain occasions

•Assembly with Design Templates/Drawings

HIGH RISK AREAS- ASSEMBLY

• Secondary Assembly

•Kitting /Bundling

• SOP with approval from legal manufacturer

•Design control

HIGH RISK AREAS- COUNTERFEIT

Counterfeit Products

• A clear SOP needs to be defined within the quality

system that will define how to handle suspected

counterfeit products

• Regulatory requirement

• Supply chain security

• Brand Integrity

COMPLYING TO REGULATIONS

•Define the Quality System as per ISO13485:2012 standard

•Get the Quality System verified and audited

•Get the Quality System certified by notified bodies to

ensure compliance to local/regional regulations

WORKING WITH SERVICE PROVIDERS

Choosing the right partner

•Audit Process

•Past Experiences

•Market Reputation

•Accreditations

Proper documentation and training

•Comprehensive contracts

•Clear policies/SOP’s

•Adequate training

HELP OF TECHNOLOGY TO MINIMIZE RISKS

• 3G/4G connectivity is a big

advantage these days

•Customised solutions are

developed by several IT

companies

• IT companies provide real

time solutions to integrate in

Healthcare Industry to

pinpoint the problem and avoid

costly damages to business

In today’s environment quality assurance ensures track

of continuity/robustness of business processes on which

the train of successful business will run. The better the

track the faster the train can run on it…