Drug Licence audit in India ()

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Drug License Audit in India

What do the auditors look for?

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Identify a key person who can lead the auditors through the facility

Educate employees about audit processKeep all required documents readyKey personnel should come early and be ready

when auditors arrive

Preparing for Audit


Two or three drug officialsAssistant or Deputy State Drug ControllerSenior State Drug InspectorsDrug Inspector from CDSCO

Central Drug Standards Control Organizationonly if it is a joint Central-State audit

For critical drugs

Audit team


PersonnelPremisesStorage and PackingProduction

What do the auditors inspect?

Materials ManagementDocumentationQuality Control


Are roles and responsibilities clearly defined and known?

Are personnel qualified and trained?Are Standard Operating Procedures available? Is personal hygiene observed?How are visitors managed?

Personnel


Does the environment pose any risk of contamination to products?

Are electrical and lighting systems adequate? Is humidity and temperature control in place?How is pest control, rodent control and bird

control done?Are the premises clean, and how are they kept

clean?

Premises


Is there adequate space for storage?Are stored products easily traceable? Is there space for quarantine storage? Is temperature and humidity control

adequate? Is sampling area identified? Is it controlled? Is dust control in place?Are packing materials stored under access

control?

Storage and Packing


Are there separate production areas for different drug categories?

How is cross-contamination prevented?Are drainage systems in place? How are they

kept clean?Are ventilation, temperature and humidity

controls adequate?Are all equipments calibrated and validated? Is the cleaning procedure adequate? Is microbial monitoring in place?

Production


How is raw material stock managed?How are they stored?How are they sampled?How are they issued?

How is raw material quality ensured?How is waste disposed?How are recalled/returned products handled?

Materials Management


Are documents written by qualified personnel?Are documents approved? Is revision control in place? Is documentation adequate?

Does it cover all processes?Are there records of past execution?

How is production process traceability achieved for shipped products?

Documentation


Is Quality Control function independent of Production?

Is sampling process adequate?How is stability testing performed?Are equipments in QC lab calibrated?How are reference standards and controls

managed? Is a separate quality assurance system in

place?

Quality Control


Do not document what you do not do. Do not do what you do not document. If it is not written down properly, it did not happen

properly. Quality of records reflects consistent product quality. Attention to detail is everything

The devil is in the details You are smart, but auditors are smarter

Never try to fool them Disclaimer

This is only a high-level overviewFollow a full GMP check-list for preparation

Things to remember


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Drug Licence audit in India ()