Why You Should Become a GMP Auditor and How to Do It

Today, most experienced pharmaceutical professionals want to become quality auditors, but they are not guided well or not having that much information about how to do it. By listening to this podcast, featuring Shoab Malek, you will get a clear idea about the role of GMP Auditor. You will also learn why and how to become one. 

Who Can Become a GMP Auditor

• All experienced professionals from any department of the pharmaceutical industry can become a GMP auditor or one who is having depth knowledge of Quality Management System (QMS), Guidelines & Process Flows.
• Every country has its regulatory authority, which is responsible for enforcing the rules and regulations and issue the guidelines to regulate drug development process, licensing, registrations, manufacturing, marketing, and labeling of pharmaceutical products.
• GMP Auditor must have knowledge of regulatory bodies of different countries like,
  • FDA – USA,
  • MHRA – UK,
  • TGA – Australia,
  • CDSCO – India
  • Health Canada – Canada
  • ANVISA – Brazil
  • EMEA – European Union
  • KFDA – Korea, PICs

International regulatory agencies like,

World Health Organization (WHO) and International Conference on Harmonization (ICH).

• Quality Assurance professionals have the advantage that they have an excellent platform to learn all things as they are the owner of all master documents.

How to Become Quality Auditor

• Read all guidelines, Master documents, and reference documents and keep yourself updated with all activities.
• Increase your document review power as an investigator.
• Upgrade your knowledge with daily regulatory updates.
• Once you become confident with experience of internal audits, then prepare yourself for vendor audits.
• After performing independent vendor audits, one can go for a certification training program on a certified Quality Auditor.
• IRCA, NSF Pharma, American Society of Quality (ASQ), and many more institutes conduct such training.
• After certification also, you have to read and review guidelines daily and have to grow your knowledge and skills.
• Technical, as well as professional skills, will help you to become as successful Quality Auditor.

The Biggest Challenge as an Auditor & How to Overcome

During an audit, the auditor may encounter deviations and critical issues. Because of the sensitivity of some of the problems, the auditees may react negatively to the findings. That may lead to a conflict, and the auditor would have to defend his position.

In this case, you could reference guidelines or compare their routine practices with high GMP standard guidelines. That could help justify the finding.

Google PodcastsApple PodcastsRSSCastBoxAnchorSpotifyRadio PublicEmail

Must-Have Skills for Becoming an Auditor

Apart from technical knowledge, soft skills are critical requirements for this role.

• Remain calm during audits
• Confidence
• Convincing power
• Decision Making
• Positive attitude

Tips for Success in Becoming a Junior Auditor

• Attend job & external training to increase your knowledge.
• To become a GMP Auditor, start to take part in an internal Audit and become an excellent internal auditor first.
• It’s quite hard for other departments (QC, Engineering, ADL, R&D, etc.) experienced professionals for becoming a GMP Auditor.
• You can move to the QA dept if he/she is from another department and learn the whole process and role of a cross-functional department.
• One can upgrade his/her knowledge by reading about all guidelines from websites.
• Attend maximum training to grow your technical knowledge.
• Regular reading and self-learning help a lot in gaining knowledge.
• Group discussions with seniors may help.

Advice for People Starting as Lead Auditor

• Update your knowledge with regulatory changes as one can have to face an audit with experienced persons.
• At that time, one can represent him/herself with a proper understanding of current guidelines.

The Biggest Mistakes New Auditors Do

• Lack of confidence/regulatory knowledge during audits can create an unnecessary discussion that can be difficult to handle.
• Only take responsibility if you are fully confident to do it independently and once you have depth knowledge of regulatory requirements and systems.

Please find below links for more detail about certification:

https://asq.org.in/certification/quality-auditor/

https://www.nsf.org/training-education/

http://www.quality.org/

Abbreviations:

1. FDA: Food and Drug Administration
2. MHRA: Medicines and Healthcare Products Regulatory Agency
3. TGA: Therapeutic Goods Administration
4. WHO: World Health Organization
5. ICH: International Conference on Harmonization
6. PICs: Pharmaceutical Inspection Co-operation Scheme
7. IRCA: International Register of Certified Auditors

[simple-author-box]