Foolproof Batch Records - Introduction

It’s one thing to write a GMP batch record, but it’s another thing to make it clear, concise, unidirectional and above all, foolproof.

At PCS we perform a lot of GMP audits. Obviously, the BPR (batch processing record) is at the top of the list of documents we would normally like to inspect. What we observe in many cases might not surprise you. Batch records which exceed FIVE-HUNDRED pages are no stranger to us, in comparison, the code that navigated Apollo 11 to the moon and back was just 1,132 pages long. If size prohibits you from being compliant, you might want to rethink your batch record, especially if the record is needed at multiple locations at the same time. The possibility for a paragraph to be left incomplete can be seen as a minor error, but operator error due to impractical batch records is unacceptable. After all, the batch record is the direct source for an operator to see what has to be done.

It’s not the operator’s fault

But it’s not just sheer size which complicates matters. Processes change over time, if the batch records are not updated accordingly, operators will find ways of making the batch record work. One way or another.

We have yet to meet an operator who loves to do a bad job at filling in batch records, we’ve seen plenty of bad batch records though, forcing the operators to do a bad job.

We observe comment sections containing data which should be recorded in distinct columns. If a comment section is missing, operators will simply use empty rows to record the data. The result? Frustrated batch reviewers and unhappy operators. We have yet to meet an operator who loves to do a bad job at filling in batch records, we’ve seen plenty of bad batch records though, forcing the operators to do a bad job.

Preventing common mistakes

So how to prevent all these common mistakes? We’ll start off with a simple approach, the EudraLex. Chapter 4.20 of Eudralax Volume IV (GMP Guidelines) provides some essential guidance for the Batch Processing Record: The BPR should be based on the relevant parts of the currently approved Manufacturing Formula and Processing Instructions. The guidance even includes a list of items which should be included:

• The name and batch number of the product

• Dates and times of commencement, of significant intermediate stages and completion of production

• Identification (initials) of the operator(s) who performed each significant step of the process and, where appropriate, the name of any person who checked these operations

• The batch number and analytical control number, as well as the quantities of each starting material, weighed (including the batch number and amount of any recovered or reprocessed material added)

• Any relevant processing operation or event and major equipment used

• A record of the in-process controls and the initials of the person(s) carrying them out, and the results obtained

• The product yield obtained at different and pertinent stages of manufacture

• Notes on special problems including details, with a signed authorization for any deviation from the Manufacturing Formula and Processing Instructions

• Approval by the person responsible for the processing operations

So what does this list teach us? It states that significant intermediate stages should be recorded. When we observe the five-hundred-page batch records, we raise the question: Are all the steps in the batch record significant? Obviously, these huge batch records are just an example. We would, however, like to invite you to have a look at your company’s batch records, is all information being requested because it is significant or because of fear of leaving out something which might be significant?

The latter could point to a lack of process understanding, which we’ll talk about in our next blog!