Production Audit Check list

GOOD AUDITING PRACTICE (cGAP)
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Check list attached

production audit checklist.doc (40.0 KB)

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I don’t mean to come across as picking on you - I really do appreciate the fact that you’re willing to post the material. But I have some questions / recommendations on this checklist as well.

One of the big things in auditing is to see objective evidence. Maybe you already do this but your checklist just has a column to indicate yes or no. That’s a very easy trap to fall into.

I presume you use this for internal auditing. If so, I would recommend that you at least document how you arrived at the yes or no conclusion. For example, “Do employees understand the basic points of the quality policy?” How does an (internal) auditor assess this? At best, this is still going to be a subjective assessment. The auditor can query them but comprehension is going to be very difficult to assess in an audit. At a minimum, I would recommend that the auditor document who was interviewed, what questions were asked, and then try to show how the responses allow the auditor to draw conclusions.

Objectives are going to be a similar challenge.

For Product ID, again, I would recommend you document what products / materials were reviewed and what the identification scheme was. This SHOULD map to an SOP so you can then assess if those materials are identified in accordance with the SOP. Note that it’s very important to tie these questions to something. As worded, material could be identified at the whim of whomever held the material. If you have a functioning quality system, the materials will be identified consistently according to procedures.

That pretty much summarizes my concerns about this checklist. The biggest point being to ensure that auditors document what they reviewed. This is invaluable after some time has passed and you’re trying to figure out why the auditor noted what he/she did.

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You are 100% right.
This is for internal auditing and I missed to mention.
I have another production audit check list under development which runs around 13 pages and it contains many points and certainly answers many questions.
In next few weeks I shall post that too.
Regards

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Can anyone provide the list of documents that an auditor review during their audits (FDA / MHRA / TGA?

Can any one provide the checklist for the preparation of regulatory audit?

Thanks & Regards,

C. Suresh

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There is not standrad format what an Auditor will also you when they inspect your facility. I have posted general document requirement earlier in this same forum. It gives you a basic idea what they look in general about Facilty, Equipments, Processes, Quality Unit, Packing & Release and other aspects of Quality Management Systems (QMS).
It is dependent up on the Auditors expertise in a particular area and his previous experiences in similar industry.

Change Control
Annual SOP review
CAPA, OOS, OOT,Complaint handling.
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.
Product Recall Handling.

Regards

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The specific requirements are described in Part II of the EU GMP guidelines, and are identical to the ICH guidelines used also in US and Japan.

Qualified Persons must confirm that drug substances were manufactured according to GMP as a part of their release of the finished dosage forms.

Marketing authorisation holders must carry out regular (every 2-3 years) audits of all of their drug substance manufacturers and suppliers. Inadequate audit programmes has been cited as a GMP deficiency in a number of regulatory authority inspections.

All manufacturing, packaging and labelling steps, from the introduction of the starting materials through to delivery to the dosage form manufacturer, must be carried out according to the GMP guidelines.
This includes:

•Synthesis
•Other procedures, eg milling, micronising, irradiation etc
•Packaging
•Breaking bulk and repackaging
•Labelling (including simply adding an “imported by” label without opening or sampling the packs)
This is a considerable workload for companies that source drug substances from many suppliers, and in-house Qualified Persons may not have the time to carry out these audits.

Many marketing authorisation holders are resolving this problem by employing contract auditors who have the resource and expertise to cover all areas of the manufacturing process. The EMEA has confirmed that this is acceptable as long as the auditor:

•Has no financial or commercial relationship with the drug substance manufacturer
•Has not been employed by the drug substance manufacturer during the previous three years
•Is contracted to, and instructed by, the drug substance user

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Thanks for sharing the check list.