Auditing API Facilities

Frank Settineri, Veracorp LLC

The current guideline for API facilities is Q7A1 which lists seventeen (17) areas to audit. How do you find the time to observe, review, interview and dig deep into a company’s operations?

First, be efficient. Send the company an agenda, requesting documents (organizational chart, plant layout, SOP list, deviations/failures); you can start auditing from the moment you arrive.  Second, prioritize the seventeen areas, spending most of your time on the three or four top priorities. Third, decide what areas you will not cover if time is short (if your API isn’t being used in a clinical trial, don’t audit that area).

Next tour the plant, starting where materials are first received and continuing along the route your API takes. Visit all areas including manufacturing, receiving, tank farms, loading and shipping docks and the warehouse.

Concentrate on what’s important: people and cleanliness. Are the people well trained and can they prove it? If you ask different people the same question do you receive similar answers? (The same answers indicate a good training program). Do the people work in a calm controlled manner or are they running around frenetically? Calm is good; running around indicates problems. How about cleanliness? If the facility is neat and clean, chances are the company is “neat and clean” about other aspects, such as paperwork, calculations, training, etc. A neat and clean plant is less likely to become contaminated. Look up at ceilings, down at floors and around the area to ascertain not only how clean the place is but also how assiduous the personnel are in maintaining its integrity.

Third, find proof that the people and facility are capable of producing compliant APIs. Review batch records, laboratory results, cleaning records, training records, preventive maintenance, deviations/rejections/customer complaints/recalls. They should be complete, correct and the data should be easily cross referenced. Digging deep into these areas will reveal problems the company has or is trying to hide; the documents should support what you observed in the plant. Also, revisit the plant after reviewing documents to clarify questions and to “catch” the company off guard. Let’s face it, when people are being audited, they know the auditors will tour the first day and not go back thereafter. Returning the third day, when work is actually being done, can be very revealing.

When done you should know about its people, cleanliness, maintenance, record keeping and problem solving abilities, which is imperative because the plant probably runs somewhat smoothly most of the time. But what happens when there is a problem? Digging deep into the paperwork and following up with additional manufacturing/laboratory visits will reveal how compliant they really are. The essence of auditing an API plant is to discover the problems they have and find out how they solve them. Needless to say (but I’ll say it anyway) if they handle problems empirically and honestly, they will likely be a GMP compliant plant. And that’s where you want your API manufactured.

1 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129098.pdf  

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