We are subcontracting our first Internal Audit. What documents/forms should we be able to provide to the Internal Auditor that they would need to conduct a thorough audit?
Here is what I plan to give them. Please add any additional documentation:
Quality Manual
Audit Nonconformity Report (auditor can list single nonconformities, their corrective actions, and their follow-up actions)
Internal Audit Summary Report (contains: audit date, department/processes audited, auditor, audit team members, list all minors/majors, strengths, post audit review, and items to address for next audit)
Should there be more? And, should we give these documents/forms to the Auditor before he asks for them or only after he asks for them?
Documents #2 and #3 I presume are your internal forms? If yes, no problem for the external auditor to use them… suggestion, ask to see so you can do a little Benchmarking…
Has your contracted auditor asked for anything? Does he have any experience with your company? processes? If I where him, besides the QM, I´d ask for the procedures, process mappings, last two internal audit reports (+plus any CAPA´s generated) and the last CB report (if you are at liberty to send it out)… just for starters…
If your blending formula is not robust or not validated it extends to different time. Then you have write a Change control document.
This is the reason now a days the company’s are performing a Validation process as SHORT TIME PRODUCT MANUFACTURING.
That means you will keep everything ready and start the batch manufacturing process and ensure that no where it is stopped or a delay occurs. You will chose batch as per capacities of your equipment.
This is performed before the regulatory audits as this question is frequently asked by Auditors as per new GMP schedules.
Secondly as per your question if normal time from 10 min is extended 15 minits : there is a FROM TIME to TO TIME column in your batch manufacturing records. The auditors will compare that with your Master Formula records. If there is any change or Deviation you are caught on the wrong foot.
Dear Chandra,
You must give following Documents to your internal auditor during Internal audits or Self inspections:
Change Control
Annual SOP review
CAPA, OOS, Complaints, Recalls
Quality agreements
Vendor qualification
Material sampling reports
Auditing report regarding consistency of inward Raw materials
Cleaning & Validation reports
Risk management reports
BMR & distribution records
BPR’s & Product reconciliation documents
In-process checks reports
Past Internal audit reports or Self Inspection reports
CAPA of past complaints, Status
Laboratory records & Log books
Calibration Master plans and all calibration records
Master records regarding contract services & their Sop’s
Ware house records, Sops , Log sheets
Environmental, Safety & Hygiene records.
Water treatment & waste water analysis
Microbiology Records & Environmental monitoring records
Training records , Evaluation ,Performance records
Health records of Company staff, Contract Staff, Operators & Contract labour.
Annual Product & Packing review records.
The main reason for submitting such records is that when ever FDA officials come they will look into these audits and will have a first impression about your internal procedures, controls & risk planning.
[b][COLOR=“black”]Why you have to increase the blending time?
Is there a insolubility or partial solubility of the product in the solution-Solubility issues?
Is the process is not stable?
Did you find a precipitation in your packed product after packing or long time before expiration in your IV pouches-- PARTICLE OR POST PRECIPITATION ISSUES?
Or any supernatent formation if you filter in sparkler filter–that is a residue over filter media?
Is it due to stability or clarity?–HAZINESS Formation[/color][/b]
You must find the why this deviation was implemented at first place-- and write a Process deviation form.
If we are reffering in blending and manufacturing operation in an IV fluid, such a variation time have to be examined and validated properly. The reason is that the previous 30 minits that was a validated parameter deviated because of a cause.What is your RCA (Root cause analysis) outcome?
To maintain the stability of changed process without any further deviation this Blending process must be examined and the batches must be kept for accelerated stability.
Keeping accelerated stability for this particular cause is always good and better. This gives a clear view if you have a regulatory inspection with short intimation time.