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As outcomes of regulatory inspections are variable and uncertain, we share 5 key takeaways, from our analysis of European Non-Compliance Reports (NCRs) of the last three years, to help you succeed in inspections.
As facility audits involve multiples areas, we provide our takeaways to assist
organizations not to miss the woods for the trees.
1. Trash course on Data Integrity
Inspectors go everywhere, especially where you don’t expect them to go! Whether it is in India, China or Saudi Arabia, inspectors have found materials and quality documents in areas ranging from: “a scrap yard outside the main building of the company”, “inside the neighboring company’s building”, to different departments or rooms, in the facility being inspected.
Data integrity lapses have been discovered when reviewing documents, like product stability data, critical starting material, employee training records, environmental log sheets, regulatory information requested during assessment of dossiers and sample retention log-books.
2. Secure Quality Control
The operations of the Quality Control (QC) unit have always needed Swiss clock like precision and deep scientific understanding. However, what has now become extremely critical is the access controls to their computer systems, which should be as secure as the Pentagon!
Most non-compliance reports had a quality department, which had inadequate knowledge of phrases like: privileges, audit trails, computer system validation, controlled access, traceability, archiving practices and restrictions on data deletion. Even if the phrases were understood, the implementation was found wanting.
Management at all levels needs to understand that any Quality-Control-failing result CANNOT be considered a trial run, and trials cannot continue until the desired result is achieved.
3. It is all about facility design
The European inspectors are extremely serious about contamination risk.
The observations, which far outnumbered those in any other category were related to: poor facility design, unacceptable condition of equipment, inability to demonstrate sterility, manufacture of toxic substances with non-toxic ones, potential microbial contamination, inadequate cleaning of equipment, lack of maintenance and/or operational problems with the air handling units.
4. Focus on deviations & training, not change controls
After contamination and data integrity concerns, improper investigations into deviations and inadequate staff training found most frequent mention in non-compliance reports.
While change control observations were cited, they were infrequent and linked to a larger concern of either data integrity, improper investigation closure or potential product contamination.
5. Lying is disastrous
The possibility of getting a compliance report disappears when inspectors find any of these:
- Sharing people between facilities located miles away.
- Giving passing certificates to failing batches.
- Not having a QC laboratory.
- Declaring that manufacturing will be stopped only for inspectors to find “no documented evidence that this stop was effective”.
While there are observations listed related to water systems, inadequate detail in batch records, unclear validation strategy etc. The ones mentioned above were the ones, which were the most recurrent.
As Peter Saxon, an expert assisting companies around the world with GMP compliance told us in an email: “European inspections start by first checking the quality of the product (product vs. facility) followed by a review of the Quality systems. For this reason it is not surprising that facility observations are the most common. But the quality systems observations usually are the most serious.
Top on the list is data falsification, no matter where it is found. You can fix anything to meet cGMP except a lie.
However, the definition of a critical observation is a moving target, since what is a verbal observation to one inspector may be critical to another and vice-versa.”
No single document can ever prepare you completely for a GMP inspection.
While the list above may be obvious to seasoned practitioners of GMP, for
others, it can serve as a guide for areas to look at prior to an
upcoming inspection.
NB: Contact us HERE if you want to receive a list of all the observations to form your own conclusions and/or read our previous analysis “Are assessment of foreign regulatory inspections (FDA/EDQM) fair?”
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