8/9 June 2021
The IPQ Journal has published an interesting article which describes increasing deviations from the operative packaging area based on figures from the FDA and the Irish Medicines Board (IMB).
According to the FDA, around 30% of all recalls of tablets reported between 2008 and 2012 involved packaging and labeling. The main causes are: label mix-ups, incorrect packaging or incorrect product insert. In addition, "presence of foreign tablets" and "defective containers" also caused recalls. The increase of deviations is enormous. The FDA saw the field alert reports (FARs) tripled between 2009 and 2012. FARs are notifications from pharmaceutical companies addressed to the FDA in case of significant issues in the production.
At the same time, the IMB noted a comparable increase - but not so drastic - although in 2011, for the first time in years, "Packaging & Labeling" was not leading the top ten list. This is only due to the fact that the IMB subdivided this defect category into "Printed Text Error" and "Packaging Component" which came in at second and third place but taken together first place. The leader of the top ranking "Contamination" also earned his place mainly because of packaging problems. The packaging components were either introducing foreign contaminants, or indeed were the contaminants themselves (i.e. gassing-off). It is interesting to mention that the defects reported in the two new categories have different critical aspects. Whereas almost 20% of the deviations reported in the category "Printed Text Error" led to a recall, it was only about 6% in the category "Packaging Component Defects". The reason for this is the fact that the incidents allocated to the latter category were mostly isolated cases with no risks for other unities on the market. The errors of the first category named above "Printed Text Error" consist of mistakes in preprinted text - text that is preapproved as opposed to text that is being printed online during the packaging process. According to the IMB, this error is mainly due to the use of Copy & Paste when creating text. For example, if an update is required to a package leaflet, the company is making the same update per Copy & Paste across all strengths of the same product. In a talk, a representative of the IMB clearly defined this error to be evaluated as a systemic one (and not as a human one - as it is often the case). Finally, she recommends to companies to cut the use of Copy & Paste out.
The IMB also saw an increase of the incidents caused by non-compliance with the marketing authorisations and this although the responsibility of the batch release by the QP also includes the confirmation of compliance with the marketing authorisation dossier. Companies should ask themselves how their QP controls it and how to provide him/her with the information required. According to the IMB, the most common reasons are: complex systems in place for the storage of registered information, inadequate controls in place for the tracking of variations and for verifying their implementation.
The complete article is normally available only to IPQ subscribers and license holders, but has been made available by special arrangement with IPQ for ECA members in the members' area.
Source: This article is taken from the IPQ (International Pharmaceutical Quality Journal).
IPQ's monthly format keeps subscribers "Inside the Global Regulatory Dialogue"™ where the initiatives are being defined that will reshape the landscape. The IPQ is one of the most important Journals in the GMP and regulatory environment. In co-operation with IPQ the ECA publishes selected articles in the members' area on the ECA website. Members also benefit from a special agreement with IPQ´s Editor in Chief Bill Paulson: an exclusive subscription fee for the IPQ Journal. You will find more information in the members' area.
To find out more about IPQ, please visit the IPQ website.