Drug Licence audit in India (www.ubio.in)

Slide 1: Drug License Audit in India Wh a t do th e a uditors look for? © 2008 ubio. All rights reserved. 1

Slide 2: 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 © 2008 ubio. All rights reserved. 2

Slide 3: 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 © 2008 ubio. All rights reserved. 3

Slide 4: What do the auditors inspect?  Personnel  Premises  Storage and Packing  Production  Materials Management  Documentation  Quality Control © 2008 ubio. All rights reserved. 4

Slide 5: 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? © 2008 ubio. All rights reserved. 5

Slide 6: 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? © 2008 ubio. All rights reserved. 6

Slide 7: 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? © 2008 ubio. All rights reserved. 7

Slide 8: 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? © 2008 ubio. All rights reserved. 8

Slide 9: 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? © 2008 ubio. All rights reserved. 9

Slide 10: 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? © 2008 ubio. All rights reserved. 10

Slide 11: 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? © 2008 ubio. All rights reserved. 11

Slide 12: 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 © 2008 ubio. All rights reserved. 12

Slide 13: ubiquitous . biology www.ubio.in © 2008 ubio. All rights reserved. 13