Production Batch Documentation based on Filling

[kamjcs]

I have a need to create production documentation similar to either the cosmetic OTC (no actives) and/or the dietary supplement gmps. The challenge I face is in the batching of the fill. We fill products of varying sizes with the identical batch of ingredients. In my thinking, which may be flawed, the critical ingredient is what I wanted to issue the batch number based upon. That way when we fill, production stages the containers from large to small and fills, then labels, then packs into a retail package. The problem I am having is how to accomplish this without creating unnecessary specifications that change based upon the particular production fill, and the creation of unnecessary paperwork that affect efficiency, not to mention the lack of staff to do it all.
Any help is appreciated and welcome. Thank you.

 

[Stijloor]

Re: Need help with Batch documentation based on filling

A Quick Bump!

Can someone help?

Thank you very much!!

 

[kamjcs]

Re: Need help with Batch documentation based on filling

Thank you

 

[El Capten]

Re: Need help with Batch documentation based on filling

I have a need to create production documentation similar to either the cosmetic OTC (no actives) and/or the dietary supplement gmps. The challenge I face is in the batching of the fill. We fill products of varying sizes with the identical batch of ingredients. In my thinking, which may be flawed, the critical ingredient is what I wanted to issue the batch number based upon. That way when we fill, production stages the containers from large to small and fills, then labels, then packs into a retail package. The problem I am having is how to accomplish this without creating unnecessary specifications that change based upon the particular production fill, and the creation of unnecessary paperwork that affect efficiency, not to mention the lack of staff to do it all.
Any help is appreciated and welcome. Thank you.

If your needs are small, a paper-based record system should work. All you need to do is show the link from the master batch to the filled containers.

Chances are that the product you want to use to fill the different containers was made up of various raw materials. Systems I have seen and worked with tend to use a master batch record, like a master recipe, and assign it a number. For example, batch number AB0001.

The master record contains a listing of what individual components or raw materials were used to make up that batch, consisting of, for example, 100 lbs of finished product XYZ.

When you then use batch AB0001 to fill containers, you need to track how many containers of each size ( 1 oz, 16 oz, etc) that use this batch of product via a package code. (I assume that you code your finished containers.) Your system would record how many containers of 16 oz product, lot coded 12345, contain batch # AB0001.
If you do any quality control checks on your product during filling or after production, your system should be using the batch numbers and package code numbers to maintain the traceability needed to demonstrate conformance to your specifications and determine where is was shipped to in the event of a recall.
Hope that answered your question. If not please be more specific on what you need to know.

 

[kamjcs]

Re: Need help with Batch documentation based on filling

Thank you for the response. Just so that I can bounce this back and am on the right track.

Our company engages in two differ types of manufacturing. We have our own retail line and we do custom, or customer, specific lines. Have spent most of my time in the custom business, I am confident in the processes required to meet the regulatory requirements. This can not be said for the make to stock or inventory retail part.

Specficically for the make to stock items, we currently do not issue any form of work order or batch record. It has been left up to the production manager what to make and how many to make. This is, for obvious reasons a problem. That said, If I were to initiate a Master record and then subsequent back records. would it be true to say that the master record contains only the recipe for the mixing of the filling ingredients and does not contain the various sized containers and other components? Then when the product was filled, there would be a separate Fill Record detailing the number of units filled with the batch/ recipe, the packaging and labeling components for each size and any in process and final inspections required? If this is the best method, I'm open to hearing how to best accomplish this and knowing who would generate these types of documents. My main cause of aggravation is a manager who refuses to document anything. Blames everyone else for the issues and has on more than one occasion hidden/ put aside in sealed boxes, items that were made incorrectly. Yes this is a huge problem for this company, but until I can demonstrate something that will provide a sense of control, I'm stuck dealing with this manager. I have only been with this company for 2 months and I'm at the point where I have to either figure this out or move on to better opportunities. Sorry to vent. Any feed back is greatly appreciated and thank you again for taking the time to read and respond to my question.

 

[El Capten]

Re: Need help with Batch documentation based on filling

Without knowing how your company management structure is setup and how many employees are available in each specific department, I can only give general guidelines.
My first recommendation would be to discuss the documentation problem with your immediate supervisor so that the manager who does not wish to follow documentation requirements is brought into line and agrees to work with the system that you will design. You need the upper management support to be behind you in your documentation effort, otherwise you will not get anywhere.

Implementation: again , I dont know who and how many people are available to carry out the activities. Your master batch should contain the formula or recipe for making the product. It should also contain a record of how much of each ingredient was used - think of a checklist. The recipe call for 100 lbs salt. The person that actually weighs the salt when making the batch uses 100.6lbs, and records the amount used and also the manufactures lot number from the bag or box it came from into the master batch record. Do this for each ingredient. If the batch needs testing or approval prior to its being packaged, the test sample will use the batch ID AB0001.

The container that holds the entire contents of that batch is identified with the batch number AB0001.

Now it's time to fill. The production manager needs to make 1000 units of product.
He would have to record in his production records when he started using batch AB0001. For example - the batch was used from cans coded F3456 through cans coded G1234 (for example). When he uses up batch AB0001 and has to start using the next batch AB0002, his production records should show when he made the change.