EU Guidance Revision: EudraLex Volume 4, Annex 15, Qualification and Validation

 

European Commission

Hello good people of the world! On February 6, 2014 the European Commission released a draft revision of EudraLex Volume 4, Annex 15 “Qualification and Validation” for comments.

The previous version (latest approved at the time of this blog post) is available here.

The new draft version is here.

Differences:

General: the guidance has increased from 11 pages to 17, with added sections on “Verification of Transportation,” “Validation of Packaging,” “Qualification of Utilities,” “Validation of Test Methods,” and “Cleaning Validation.”

Detailed differences in each section are highlighted below. Continue reading EU Guidance Revision: EudraLex Volume 4, Annex 15, Qualification and Validation

Good Numbering Practices

Numbering

Hello, good people of the world! In industry, we have a lot of cause to number things. We number equipment, documents, instruments, SOPs, processes, etc. so that they can be easily identified and referenced. What are the cGNPs (current Good Numbering Practices)?

  1. Identification numbers should be unique. This is critical and fundamental. Whatever you’re numbering, each item in the collection must have a unique number so that it can be identified and not confused with something else. This may sound trivial, but it can be difficult when a collection gets large if you don’t have a robust way of managing numbers (e.g. a relational database).
  2. The numbering scheme should be scalable, meaning adding additional numbers should not cause undue burden, even if  you have to add a large amount.
  3. The numbering scheme should be informative. You want the number to immediately tell a person something about the item being numbered. A sequential number is meaningless. A random number even worse.
  4. The numbering scheme should be reasonable length. You want to convey as much information as possible in the number without making it too long. What’s too long? Any more that 15-20 characters is getting too long.
  5. Most importantly: define your numbering scheme. Make it easy for anyone to know what each part of your numbering scheme means, and how new numbers are determined. Your numbering scheme should not be mysterious!

Examples of good numbering schemes I’ve seen in industry:

  • For equipment: T-0310-1, where T stands for tank, 03 is the building number, 10 is a functional area (e.g. fermentation, purification, etc.) defined in an SOP, and 1 is a sequential number
  • For validation documents: AREA-TYPE-YYxxx.00 where AREA is the functional area, TYPE is the document type (.e.g. IOQ, PQ), YY is the two-digit year, xxx is the next sequential number for the unique AREA, TYPE, YY combination, and 00 is the revision (starting at 00 for initial version).

What numbering schemes do you like? Leave a comment below and please share this post with whomever you think would benefit.

Fill Line Qualification

Aseptic Liquid Filling Line

Hello, good people of the world! This post is about aseptic liquid vial fill line qualifications. I’ve seen a few of these in my time, and in some ways they’re easier to qualify than other systems, in some ways more challenging. Fill lines may be easier because these systems are typically off-the-shelf with less customization. They may be more complicated because you’re dealing with a lot of interconnected equipment and automated control.

I’ve worked with Bausch-Stroebel (bausch-stroebel.com) and Bosch (bosch.com) fill lines, but TurboFil, Marchesini, and IMA are also common vendors.

The standard components of an aseptic liquid vial fill are: Trayloader/Unloader, Vial Washer, Depyrogenation Tunnel, Filler, Checkweigher, Stopperer, and Capper.

What considerations do you always keep in mind? Leave a comment below and please share this post with whomever you think would benefit..

The Validation Department – a Producer of Data

Data Production

Hello, good people of the world! So you’re in Validation. Or any part of the Quality department. You don’t manufacture anything, you don’t sell anything – what is your role?

You are in the business of information, and you have many customers. Your first and most important customer may be the regulatory agencies your product(s) are subject to, but you’re also serving Manufacturing, Engineering, and the company owners and shareholders. That means you better be good at handling information. Continue reading The Validation Department – a Producer of Data

Recovery Studies – What the Heck?!

Recovery

Hello, good people of the world! Recovery studies are studies to support surface swab processes. They typically involve “spiking” a “coupon” made from a particular material with a known amount of the contaminate you’re interested in, and then systematically quantifying the amount recovered via the swab process.

You’ll need to perform recovery studies for all product-contact materials you have in your manufacturing process. These typically include 316L stainless steel, PTFE, glass, etc.