According to an article on Bloomberg J&J is “taking over” production at one of the vendors making the J&J vaccine after a reported manufacturing error resulted in the loss of a large batch of vaccine component. The article implies that J&J personnel will now have primary responsibility for activities at their vendor. This is consistent with the idea that when an employee makes a serious mistake, he/she is replaced with another employee who is expected to do better. While this concept is applicable to pharma just like other businesses, it is not the full or adequate way to address serious problems in production or drug development. That is because the quality of the final product, whether a drug product or a new drug application, should never be dependent solely on the perfect performance of employees nor on perfect testing/evaluation of the final product.
This kind of quality should be primarily determined by production procedures. Adequate standard operating procedures, safety interlocks built into the production procedures and machinery, and physical isolation of machinery and intermediate materials, should minimize the potential for errors like cross contamination happening in the first place. So, while quality testing/auditing, etc., are important, the “system” must be set up to be as “foolproof” as possible from the beginning.
So, when an error occurs, it is standard practice not to just replace or retrain whomever made the mistake, but also to initiate a “corrective and preventive action plan” or CAPA aimed at, among other things, preventing the error from recurring. Anyone who has worked in drug development for a significant period of time will be familiar with CAPAs.
Given the complexity of drug manufacturing and what I think is the greater complexity of drug development, it is inevitable that mistakes will be made. The key is to employ people who are familiar with the common problems that arise and therefore can set up systems that minimize the chances for common problems. Experienced people can also set up systems for evaluating quality on an ongoing basis. Once this is done, it is important not just to correct mistakes, but also to alter systems so as to minimize the probability of recurrence.
As I tell the teams I lead, mistakes are inevitable and their consequences tend to grow as time goes by. So, it is important to identify mistakes quickly so they can be corrected before their consequences become more dire. Once identified, it is equally important to modify procedures to minimize the chance of recurrence; i.e. “let’s make different mistakes and not keep repeating mistakes of the past”. The actions taken as a result of a CAPA should be fully documented. The objective is to continuously improve quality as time goes by and to document the organization’s commitment to quality work.
It will be interesting to see what happens at another company that has had very public apparent missteps related to their vaccine. Will they blame a single individual or a few people or will they recognize that systems vulnerable to mistakes by singe individuals or small groups are inherently weak and thus require strengthening via comprehensive CAPAs?
Update: According to a report from the New York Times, problems at the vendor were apparent before the latest batch failure. This would be especially unfortunate because it is at least theoretically possible that the recent failure could have been avoided if earlier actions, presumably via CAPAs, had been taken.