The Role of Culture in GMP Compliance

The role of culture in GMP Compliance

Two manufacturers of active pharmaceutical ingredients (API), one in Asia and the other in Europe, recently failed inspections for the way they handled customer complaints. However, the similarity ends there, since their approach towards handling the same problem was completely different. We wonder this week, if there is a role of culture (country or corporate), which impacts the compliance of companies?

Polydrug Labs, an API producer in India, received a non-compliance report from the EDQM and the concerns observed varied from “customer complaints deliberately unregistered in the official logbook” to “storage of quality documents in an uncontrolled location, involving staff from Quality Control, Quality Assurance, Maintenance and Production”.

During the same period, Czech based API manufacturer, VUAB Pharma, received an FDA warning letter in which, “failure to adequately investigate and resolve all quality-related customer complaints” was highlighted as one of the main observations.

While customer complaints were the common thread, there seems to be an interesting difference in the way the problem was ‘managed’ at the two facilities.

What is the difference in compliance approaches between Europe and Asia?

Our review of the latest available non-compliance concerns posted by the FDA, EDQM and ANVISA led to an interesting discovery: the single biggest compliance concern today in Asia, evidence of flagrant data falsification, wasn’t reported in any of the European inspections.

The observations at Polydrug Labs are consistent with other Asian facilities where observations of documents found in scrap yards, rewriting of original documents or paperwork filled by personnel absent when they said they were present are common.

Hospira’s Italian plant was however found performing trial sample injections “prior to official testing. Immediately after the trial injections were completed, the official samples were analyzed.” (more on Hospira later).

If data integrity isn’t the problem, what are the severe non-conformities observed in European inspections?

Whether it be Hospira’s facility in Italy, which had 103 complaints related to product changing color, Wyeth Lederle’s unit in Italy, which had water infiltration in a sterile room or UK’s SCM Pharma, which identified microbial contamination in their product, in all cases the investigations “did not sufficiently pursue or determine root causes” (from the FDA warning letter issued to VUAB Pharma).

Our review concluded that the single most consistent reason for European companies to have non-compliances is deviations are not sufficiently investigated, documented and explained.

What about Hospira, which is a global company?

The warning letter issued to Hospira’s facility in Italy makes two references that the violations observed are similar to those found during the inspection of Hospira’s Indian operations.

Hospira, a global generic giant, has had facilities fail in United States, Australia, India and Italy, which indicates a role of “corporate culture” in the approach towards compliance.

If Hospira has a ‘corporate culture issue’, how can we explain the difference between Polydrug Labs in India and VUAB Pharma in Czech Republic?

After speaking to industry veterans, with global pharmaceutical experience, the conversation often comes up regarding the difference of cultures between Asia and the Western countries. The differences are so well known in other industries that global bank HSBC has run advertising campaigns built on the subtle differences in culture for years.

In view of these differences of cultures, how does the approach towards GMP change?

We wonder if elimination instead of investigation of deviations in some companies in Asia, is an outcome of the intimidation subordinates feel about asking clarifying questions. In the Asian culture, it may either challenge a higher authority and/or risk loss-of-face.

How does the loss-of-face risk play a role when Asian companies need to take positions? Would an Asian company be comfortable to refuse an inspection like Ethypharm did with ANVISA, or tell the inspectors that data is simply not available like VUAB Pharma told FDA inspectors who requested back up electronic data?

Foreigners, in Asia, are usually given a special and somewhat exalted status. Does this impact the confidence with which Asian companies approach Western inspectors? Especially when there is a communication gap created because of the difference in languages?

At the same time, is the European problem of not digging into issues deep enough a result of trying to solve problems as efficiently as possible even if it does not factor in the thinking of others?

While the observations listed in most reports are consistent with our previous analysis, “Where companies who fail EDQM inspections go wrong”, we believe that there is a cultural element, which also needs to be factored in, when developing a strategy for compliance.

Here is an entertaining explanation for those interested with the concept of differences between the West and the East: http://www.elainer.com/2010/06/the-fundamental-cutural-differences-between-east-and-west/

Annexure

Table// Inspection reviewed for this report:

Inspections reviewed for this report
Company Name	Country	Date of Inspection	Health Authority
VUAB Pharma	Czech Republic	June 2014	US FDA
Hospira S.p.A	Italy	May 2014	US FDA
IDT Biologika GmbH	Germany	December 2014	US FDA
Wyeth Lederle s.r.l.	Italy	November 2014	US FDA
Ethypharm	France	June 2015	ANVISA
AGEPHA	Austria	March 2014	Austrian Medicines and Medical Devices Agency
Relonchem Limited	United Kingdom	February 2015	UK MHRA
Manuel Riesgo S.A.	Spain	October 2014	Spanish Agency of Medicines and Medical Devices
SCM Pharma	United Kingdom	March 2014	UK MHRA
Moorfields Pharmaceuticals	United Kingdom	May 2014	UK MHRA

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Image Credit : People on Different Continents by Roy Blumenthal is licensed under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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