Tuesday, April 26, 2016

Audit readiness in Pharma industry and facing a regulatory audit

Audit is always additional headache for Pharmaceutical industry.  People from lower level to higher management are afraid for any regulatory audit. But facing of audit is not like a rocket science. As we are working for our organization same way auditors are working for their regulatory authority.
We are the knowledgeable fellow of our organization, because we are handling the process/ system routinely. Auditor who is not a part of our organization and even they know less and understand less about our organization. How can they able to find a single fault of our system? If it is so, then it is a big question on the understanding of our own system.
Some time in my experience I have observed that when auditor ask any SOP, we read it in front of auditor and struggle to get the information what the auditor ask. It seems that first time we are reading or we have seen that SOP. Try to explore the people those who are handing the procedure every day. Don’t try to justify more in front of auditor or don’t do more knowledge sharing in front of auditor. Just be with your written approved procedure only. The main principle of audit is tell whatever written in your approved procedure and show whatever evidence you have.
Give clarity to auditor but not to share unnecessary information to them. If you observed what auditor is asking you don’t have, so don’t try to justify wrongly. But you can take an attempt if you think whatever you are doing that you can justify scientifically. After your given justification if auditor satisfy then well but he is not satisfy, then don’t do unnecessary argument with him. It better to write a respond against an observation.
Today we will provide an example of ,How to face auditor ?, when he/she asking about the Utility system in your facility? What are the document you should show him/her? and what will be the flow of document? What are the document come in to picture when we talk about Utility?
 Now a days pharmaceutical industry are facing lots of trouble with facing audits. But once you have gain the higher confident level with auditor, it will be helpful. The main problem of audit observed that is following,  
  • Integrity issue 
  •  Lack of process/product/system  
  • Improper presentation
  • Communication problem
Here we will discuss about the problem related to Presentation. Whenever auditor asking about the utilities , first thing in our mind is that where from we should start. Here we will provide brief idea On handling of audit of utility area. Following document need to be ready for utility audit: 

·         Water:
    • Diagram containing purification steps: A clear diagram is required showing the each and every steps for purifications.
    • Distribution system, using and sampling points: All the sampling point details
    • System maintenance:
·         Pure Steam:
    • Points of use, Specification,
    • Routine Monitoring Program (Micro and Chemical) and
    • Last Annual Review. System maintenance.
·         Water system documentation:
    • Specifications of the different water grades used by the company.
    • Routine monitoring procedure and results obtained last year.
    •  Trend analysis.
    • Sanitization procedures and records.
·         HVAC:
    • AHU distribution,
    • Pressures differential;
    • diagram showing rooms classification and
    • Activities performed in every room.
    • System maintenance.
·         Gases for pharmaceutical purposes:
    • List of Gases that are in direct contact with products.
    •  Specifications and Routine Monitoring Program (Microbiological and Physicochemical).
    • System maintenance.
·         Environmental monitoring :
    • Frequencies,
    • Sampling points,
    • Sampling techniques,
    • Testing,
    • Evaluation and results obtained within last year.
    • Specifications for viable and non-viable contamination.
    • Trend analyses.
    • Periodical Re-qualification approach and records.

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