Hello Everyone,

I am in need of some guidance regarding change control for a drug manufacturer - but not for document changes.

I have recently been asked by my company to re-vamp our cc process. There have been a lot of meetings to discuss when a change control needs to be initiated for equipment and facilities.

I have purchased and read through David N. Muchemu's book and I guess I am hoping to hear from others on a way to define what needs a change control when dealing with equipment and facilities.

I am looking forward to hearing how others in the industry have implemented.

I don't want to swamp the cc system with unnessary requests, but at the same time, I want to make sure I understand (and my company) why (or why not) a cc is needed.

Thanks!

kk

what needs a change control when dealing with equipment and facilities.

This is how we deal with change control:

1.0 SCOPE:

1.1 This document defines the procedure to request and obtain approvals for changes to products, raw materials, packaging supplies, specifications, processing operations, vendors, written procedures, controlled forms, and any other practice or attribute that affects the quality, purity, strength, identity or safety of finished products.

So if the equipment or facilities being changed could affect the "quality, purity, strength, identity or safety of finished products", we would initiate a change control.

If we're painting the walls, or putting in a new ceiling - no change control.

If we're installing new mixing tanks - yes change control.

Do you use any sort of risk methodology to determine if the change impacts the quality, purity, strength, identity or safety of finished products of the product?

Determining if it will effect seems to be the hardest part. For example, you stated that you would issue a cc to replace a ceiling - but would you if the ceiling was not constructed of the same materials so you could determine IF it would impact SQIPS?

I really appreciate the feedback :)

SQIPS?

I knew there had to be a suitable acronym.

Do you use any sort of risk methodology to determine if the change impacts the quality, purity, strength, identity or safety of finished products of the product?

Sure, a risk analysis would be performed. We don't have a flow chart or anything like that to do this, however. It would be determined on a case-by-case basis.

Determining if it will effect seems to be the hardest part. For example, you stated that you would not issue a cc to replace a ceiling - but would you if the ceiling was not constructed of the same materials so you could determine IF it would impact SQIPS?


If we think there was a chance to impact SQIPS, we would start a change control, which would most likely lead to a validation to show the change will not impact SQIPS.

Scott Catron:
i agree with the scope you have mentioned; although not a verbatim, our scope-statement used to be something like this "...all the processes/procedures defined from product development to the distribution...and having impact on quality, purity, strength, identity or safety of product".. a separate overview for list of processes along with the examples of inclusions and exclusion criteria was included in the SOP,

[only that we used to summarise the above characteristics as SISPQ..sounds to be rhythemic! ]

1. let me just clarify/add to the example you have provided on the 'ceiling replacement/painings' work; it will depend on the area where the activity is being done; if its done in 'controlled-area' then obviously it has to go through change control.

2. coming to the risk assessment, i think its an integral part of the CC process.[ not otherwise, where risk assessment of a change triggering CC!]

and eager to hear your thoughts on above feedback

in summary, i feel that there should be proper evaluation mechanism of proposed changes and it should be documented appropriately about the decision and the follow-up activities for implementation of changes.

though it may increase the load on the QA activities, it makes sense to trigger a CC and evaluate the impact of it before clearing the change for implementation.

also, have a look at following website for an example of CC procedure from FDA
http://www.fda.gov/cdrh/qsr/09docnt.html

hope it helps.
thanks