paulag

Quite Involved in Discussions
#1
Dear all,

One of our facilities manufactures primary packaging containers such as ampoules, their processes are GMP compliant, everything OK so far.

As a strategic vision, this plant shall be enabled to also perform pharmaceutical packaging / filling operations for the EU and US market.

How can we best perform a gap analysis on what we need to install, implement, qualify, train, etc, to avoid any noncompliance for future packaging operations?

Thank you in advance for every red thread I could follow...

Best regards

:thanx:
 

Marc

Retired Old Goat
Staff member
Administrator
#3
The first question is, have you determined all applicable standards and regulations, and do you have copies of them?
 

paulag

Quite Involved in Discussions
#4
Hi Marc,

They are ISO 13485 and 15378 certified, do pretty well in audits, follow the cleanroom and hygiene standards, - not sure about other technical standards, though...
 

Marc

Retired Old Goat
Staff member
Administrator
#5
<snip> How can we best perform a gap analysis on what we need to install, implement, qualify, train, etc, to avoid any noncompliance for future packaging operations? <snip>
Drugs are not my area of expertise, but as far as gap analysis - I assume it would be like other fields (my answer is thus general). I would make a matrix of all requisite standards, regulations, etc. and do the analysis against it.

I'm not sure how many pharm people visit here regularly, but hopefully one can be more specific.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
Having been audited nearly monthly by big pharma companies over the last 2 years, I can tell you that drug manufacturers in the US don't much care about ISO 13485 at this time.
They care far more about 21 CRF Part 210 for you're offering.

If I was in your shoes I would hire a consultant to do a gap analysis. Preferably a consultant who was once an FDA drug inspector.
 

Ajit Basrur

Administrator
Staff member
Administrator
#7
Hi Marc,

They are ISO 13485 and 15378 certified, do pretty well in audits, follow the cleanroom and hygiene standards, - not sure about other technical standards, though...
I think you are looking at wrong standards - ISO 13485 is purely on medical devices, while the ISO 15378 refers to primary packaging materials for medicinal products.

As Scott mentioned, refer to

21 CFR Part 210

21 CFR Part 211

Also refer to ICH (International Conference on harmonization) documents, namely

ICH Q8, Pharmaceutical Development

ICH, Q9, Quality Risk management

ICH, Q10, Pharmaceutical Quality System

The above documents will bring you closer to the Drug filling and packaging operations.
 
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