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

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Drug regulatory requirements in India, Free audit checklist (high-level) on drug licensing for pharma, ivd consultants and manufacturers.

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

  1. 1. <ul><li>Drug License Audit in India </li></ul><ul><li>What do the auditors look for? </li></ul>
  2. 2. <ul><li>Identify a key person who can lead the auditors through the facility </li></ul><ul><li>Educate employees about audit process </li></ul><ul><li>Keep all required documents ready </li></ul><ul><li>Key personnel should come early and be ready when auditors arrive </li></ul><ul><li>Preparing for Audit </li></ul>
  3. 3. <ul><li>Two or three drug officials </li></ul><ul><ul><li>Assistant or Deputy State Drug Controller </li></ul></ul><ul><ul><li>Senior State Drug Inspectors </li></ul></ul><ul><ul><li>Drug Inspector from CDSCO </li></ul></ul><ul><ul><li>Central Drug Standards Control Organization </li></ul></ul><ul><ul><li>only if it is a joint Central-State audit </li></ul></ul><ul><ul><ul><ul><li>For critical drugs </li></ul></ul></ul></ul><ul><li>Audit team </li></ul>
  4. 4. <ul><li>Personnel </li></ul><ul><li>Premises </li></ul><ul><li>Storage and Packing </li></ul><ul><li>Production </li></ul><ul><li>What do the auditors inspect? </li></ul><ul><li>Materials Management </li></ul><ul><li>Documentation </li></ul><ul><li>Quality Control </li></ul>
  5. 5. <ul><li>Are roles and responsibilities clearly defined and known? </li></ul><ul><li>Are personnel qualified and trained? </li></ul><ul><li>Are Standard Operating Procedures available? </li></ul><ul><li>Is personal hygiene observed? </li></ul><ul><li>How are visitors managed? </li></ul><ul><li>Personnel </li></ul>
  6. 6. <ul><li>Does the environment pose any risk of contamination to products? </li></ul><ul><li>Are electrical and lighting systems adequate? </li></ul><ul><li>Is humidity and temperature control in place? </li></ul><ul><li>How is pest control, rodent control and bird control done? </li></ul><ul><li>Are the premises clean, and how are they kept clean? </li></ul><ul><li>Premises </li></ul>
  7. 7. <ul><li>Is there adequate space for storage? </li></ul><ul><li>Are stored products easily traceable? </li></ul><ul><li>Is there space for quarantine storage? </li></ul><ul><li>Is temperature and humidity control adequate? </li></ul><ul><li>Is sampling area identified? Is it controlled? </li></ul><ul><li>Is dust control in place? </li></ul><ul><li>Are packing materials stored under access control? </li></ul><ul><li>Storage and Packing </li></ul>
  8. 8. <ul><li>Are there separate production areas for different drug categories? </li></ul><ul><li>How is cross-contamination prevented? </li></ul><ul><li>Are drainage systems in place? How are they kept clean? </li></ul><ul><li>Are ventilation, temperature and humidity controls adequate? </li></ul><ul><li>Are all equipments calibrated and validated? </li></ul><ul><li>Is the cleaning procedure adequate? </li></ul><ul><li>Is microbial monitoring in place? </li></ul><ul><li>Production </li></ul>
  9. 9. <ul><li>How is raw material stock managed? </li></ul><ul><ul><li>How are they stored? </li></ul></ul><ul><ul><li>How are they sampled? </li></ul></ul><ul><ul><li>How are they issued? </li></ul></ul><ul><li>How is raw material quality ensured? </li></ul><ul><li>How is waste disposed? </li></ul><ul><li>How are recalled/returned products handled? </li></ul><ul><li>Materials Management </li></ul>
  10. 10. <ul><li>Are documents written by qualified personnel? </li></ul><ul><li>Are documents approved? </li></ul><ul><li>Is revision control in place? </li></ul><ul><li>Is documentation adequate? </li></ul><ul><ul><li>Does it cover all processes? </li></ul></ul><ul><ul><li>Are there records of past execution? </li></ul></ul><ul><li>How is production process traceability achieved for shipped products? </li></ul><ul><li>Documentation </li></ul>
  11. 11. <ul><li>Is Quality Control function independent of Production? </li></ul><ul><li>Is sampling process adequate? </li></ul><ul><li>How is stability testing performed? </li></ul><ul><li>Are equipments in QC lab calibrated? </li></ul><ul><li>How are reference standards and controls managed? </li></ul><ul><li>Is a separate quality assurance system in place? </li></ul><ul><li>Quality Control </li></ul>
  12. 12. <ul><li>Do not document what you do not do. </li></ul><ul><li>Do not do what you do not document. </li></ul><ul><li>If it is not written down properly, it did not happen properly. </li></ul><ul><li>Quality of records reflects consistent product quality. </li></ul><ul><li>Attention to detail is everything </li></ul><ul><ul><li>The devil is in the details </li></ul></ul><ul><li>You are smart, but auditors are smarter </li></ul><ul><ul><li>Never try to fool them </li></ul></ul><ul><li>Disclaimer </li></ul><ul><ul><li>This is only a high-level overview </li></ul></ul><ul><ul><li>Follow a full GMP check-list for preparation </li></ul></ul><ul><li>Things to remember </li></ul>
  13. 13. <ul><li>ubiquitous . biology </li></ul>www.ubio.in

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