Was your biopharm manufacturing facility prepared for last week’s dock workers strike?

If there is anything the last few years has taught us, is that havoc can strike at any time on your supply chain.

Everything from active ingredients to plastic pipettes could suddenly have no longer been available had the strike dragged on.

What’s your contingency plan for supply chain disruptions?

Where are those spare parts when you need them?

It’s always going to be a balance between the cost to establish, organize and maintain a robust spare parts system, and being prepared for when – not if – a piece of equipment breaks down.

One way to “split the difference” is to focus on the critical pieces of equipment in your biopharm manufacturing facility.

Leaning in on your vendors can also help in understanding what they’ve seen with other peers in the industry when it comes to maintaining adequate spares.

When it comes to running a biopharmaceutical manufacturing facility, you need supplies. Supplies can be broken down into 4 general categories:

1. Consumables
2. Raw materials 3
3. Spare parts
4. Utilities

In today’s episode of Q&A with QuneUp, I introduce each of these general categories of supplies.

I’ll take a deeper dive into each one separately in the coming weeks.

Stay tuned!

Consumables refer to anything used in the biopharmaceutical manufacturing facility that is typically only used one time on the production floor.

Using consumables is one way to fight against contamination risk.

Consumables can be items used by personnel in executing tasks on the production floor.

Consumables can also be items needed to run a bioreactor.

Listen in for more details on the various types and uses of consumables on the production floor.

It’s always a good idea to add images, diagrams and other visual aids into your SOP to help your reader fully grasp the content. However, it’s important not to go overboard, or else you’ll run the risk of cluttering the SOP, and losing your reader’s interest.

That’s where the Appendix section comes in. That’s where you put everything that adds context to the reader, but is not absolutely necessary when it comes to actually executing the SOP.

Things to stick in the Appendix:

• Pictures of fully assembled hose connections
• Aerial view of the process area
• Calculations
• Detailed graphs

To understand the “why” behind what’s going on the production floor at a biopharmaceutical manufacturing facility, we turn our attention to a document called The Process Description.

This document is packed with tons of information on topics including:

• Test results from R&D and pilot studies
• Why a particular cell line was chosen
• The composition of the cell media and its effectiveness during cell growth studies
• The number of cell culture passages needed for scale up
• The duration for the runs for the seed reactor and production bioreactors
• Optimum conditions for operating the bioreactors
• Separation conditions
• Downstream separation best practices
• Optimum conditions for short and long term storage

The Process Description helps you go beyond just the surface of the equipment and takes you on a deep dive into the process going inside the equipment itself.

In today’s episode of Q&A with QuneUp®, we’re taking a closer look at the Prerequisites section of the SOP. This is where you let your readers know what other things, steps, procedures, or access levels the reader needs to obtain before they can get into the meat of the SOP. You don’t want your reader to get halfway through the SOP, only to realize they’re missing some critical info to complete the SOP. Give your reader the tools they need with a well thought out Prerequisites section.

In today’s episode of Q&A with QuneUp, I’m taking a deeper dive into the Safety Considerations section of the SOP. The safety considerations section needs to clearly identify any hazards in the area and list all safety precautions necessary to execute this SOP.

A few things to consider for the Safety Considerations section:

• Mobile equipment cross traffic
• Elevated heights
• Lock Out Tag Out
• Machine safety guards

This list is not meant to be all inclusive, but to get you thinking of how detailed the SOP needs to be from a safety perspective.

At the end of the day, the goal is that everyone leaves the facility the same way they came in.

What’s in a title? When it comes to SOPs in biopharmaceutical manufacturing facilities, the title is everything. You want your reader to quickly figure out what this SOP is all about from just a few words in the title.

Why do I need to read this SOP?

In today’s episode of Q&A with QuneUp, we’re taking a deep dive into the Purpose section.

I know sometimes we tend to gloss over the Purpose section, but it’s critically important. The Purpose section is meant to quickly orient the reader as to what this SOP is all about, and why they should be reading it in the first place.

The Purpose section also needs to be short and sweet. Listen in for more details.

In today’s episode of Q&A with QuneUp, I’m spending some time talking about what an SOP – Standard Operating Procedure – is NOT.

Today’s episode of Q&A with QuneUp is here. I’m taking a closer look at the key words that occur most frequently in the FDA 483 Warning Letters issued in 2023.