Drug License Audit in India What do the auditors look for?

Drug License Audit in India

What do the auditors look for?

Identify a key person who can lead the auditors through the facility Educate employees about audit process Keep all required documents ready Key personnel should come early and be ready when auditors arrive Preparing for Audit

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

Educate employees about audit process

Keep all required documents ready

Key personnel should come early and be ready when auditors arrive

Preparing for Audit

Two or three drug officials Assistant or Deputy State Drug Controller Senior State Drug Inspectors Drug Inspector from CDSCO Central Drug Standards Control Organization only if it is a joint Central-State audit For critical drugs Audit team

Two or three drug officials

Assistant or Deputy State Drug Controller

Senior State Drug Inspectors

Drug Inspector from CDSCO

Central Drug Standards Control Organization

only if it is a joint Central-State audit

For critical drugs

Audit team

Personnel Premises Storage and Packing Production What do the auditors inspect? Materials Management Documentation Quality Control

Personnel

Premises

Storage and Packing

Production

What do the auditors inspect?

Materials Management

Documentation

Quality 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

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

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

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

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

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

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

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 overview Follow a full GMP check-list for preparation Things to remember

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 overview

Follow a full GMP check-list for preparation

Things to remember

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