If ambitious pharmaceutical companies tested their operations and quality personnel, they might pose the question: Is there
a reason why batch records cannot be reviewed and approved within one business day? This question is not just important from
an operational point of view, but it is also important from business and regulatory points of view.
If there are delays in processing batch records (BRs) then product cannot be released into the supply chain. The waiting time
results in excessive work-in-progress being held.
There is considerable operational benefit in decluttering and creating a fast flow environment. In these days of cost scrutiny
and efficiency focus, it is necessary to streamline non-value adding processes such as batch record reviews. Slow processes
signify inefficiency and unnecessary cost. If streamlining is not achieved, the risk of non-compliance and quality system
failures can heighten with overly bureaucratic BRs and tortuous review and approval cycles. Auditors and inspectors may focus
on incomplete or nonstandard paperwork leading to even more problems. In other words, the business case for making sure there
are no barriers or impediments to a one-day approval of BRs is clear.
So, if this is important, why do these processes take so long? The most popular reason would be that investigations resulting
from manufacturing deviations are often required; these take time and until these investigations are complete, the BRs cannot
be signed off.
There are a range of well-known tools and techniques for optimizing the deviation-management process so that it runs quickly
and effectively. Rapid root-cause investigations teams trained to use Define, Measure, Analyze, Improve, Control (DMAIC) approaches,
are armed with standard ways of categorizing deviations supported by black-belt facilitators. Appropriate tools and a well-trained
team should be brought into play as soon as any critical deviation is identified. Such an approach is now considered best
practice across the industry.
Another commonly cited reason given for why a one-day close cannot be achieved is that key people are not available to immediately
execute a task in the process and the process then has to wait until they are available. Quality assurance (QA) department
personnel, for example, may be located away from the production floor and work in a way that is not aligned to the needs of
the process. The reason for delay can be completely eliminated by finding a way to have QA embedded into the team where and
when needed. This setup might be enabled by a shift to process-oriented organization principles or simply by moving the desks
of the QA team into the production office. Nonaligned shift patterns are a bit trickier but can be tackled.
To further streamline BR review, QA should only focus on critical parameters and review each parameter once. Capturing errors
and omissions on the same shift reduces risk and improves quality of resolution. BRs, therefore, should be reviewed and corrected
immediately, and with the people who are executing the production task. Setting a rule that the personnel do not leave until
the batch is cleared is a good approach.
Poor BR design can also lead to overly lengthy review and approval. For some companies, compliance and completeness are the
only concerns in the design of the BR. There is little or no consistency in the way requirements are stated in the document,
and the entry format and location are not clear to the operator. The document and work sequence differ, confusing the operator.
The operator must regularly interpret tolerances in the BR and make many transcriptions. These procedurs are a recipe for
error and delay.
To achieve a one-day BR review and approval, a right-first-time (RFT) culture must pervade the organization. This means that
95% of batch records should be RFT.
Best practice dictates that the BR be error-proofed, based on a clear methodology to make the person and document interface
error-free. There should be an obvious pattern to the way requirements are stated and laid out that helps the user. In addition,
the BR should mirror the operator work sequence. No mental calculations and few transcriptions should be needed to complete
the BR. Only the required information should be entered. Crucial or license-related parameters need to be highlighted so they
are clear to the operator. There should be an obvious distinction for parameter outputs between target and required. In addition,
there needs to be a statement of policy and principle that protects BR simplicity and effectiveness from being eroded over
time with additional statements, checks, and signatures from poorly-constructed corrective action and preventive action changes.
How novel is this? If one pulls out benchmark research showing where companies have actually streamlined their BR review process,
they would see lead times coming down from tens of day (30 is common) to single figures, then pushed on to achieve one day
(or less) for a significant percentage of batches (> 90%). For investigations, common industry practice is now 80% complete
within eight working days.
The pharmaceutical industry is packed with highly skilled and educated people with years of experience making product and
getting the paperwork correct. Industry personnel should be able to find a way of filling in a pack of documents within a
reasonable timeframe to achieve a one-day BR signoff.
Simon Chalk is director of the BioPhorum Operations Group, firstname.lastname@example.org