Category Archives: Qualification

WHO’s Draft Guidelines on Validation May 2016

Hello good people of the world! On May 15, 2016, the World Health Organization released its draft Guidelines on Validation. It is available on the WHO website for download here.

This post covers my review of the guidance. Continue reading WHO’s Draft Guidelines on Validation May 2016

Commissioning and Qualification of Process Instrumentation

Pressure Transmitter

Hello good people of the world! Today’s post is on the commissioning and qualification of instruments used in process measurement and control. Instruments may be used to measure such things as flow, temperature, pressure, level, weight, conductivity, etc. In use, many of these parameters may be quality critical, so proper commissioning and qualification is key! Continue reading Commissioning and Qualification of Process Instrumentation

Quality During Construction

Construction Quality Assurance

Hello good people of the world! This blog post covers Construction Quality Assurance, based on an article that appeared in the Nov/Dec 2012 edition of Pharmaceutical Engineering titled “Assured Construction Quality Saves Time and Money.” All credit goes to the authors: Jay Lad of Skanska Pharmaceutical Group and Bruce Beck of Eli Lilly. Continue reading Quality During Construction

SharePoint 2013 in a GMP Environment

SharePoint

Hello good people of the world! Today’s post is about implementing and using Microsoft SharePoint 2013 in a regulated (GMP) environment.

Microsoft has published a comprehensive guide to SharePoint 21CFR11 compliance, which can be downloaded for free here.

Basic software requirements are:

Continue reading SharePoint 2013 in a GMP Environment

Container Closure Integrity Testing

Hello good people of the world! The present post concerns itself with Container Closure Integrity (CCI) testing. CCI testing is an integral part of packaging validation, involving primary packaging such as ampoules, blisters, bottles, vials, syringes, tubes, etc. Biopharmaceuticals are typically packaged in hermetically-sealed containers to prevent the ingress of any liquid or gas that could be reactive or carry microorganisms. Packaging may also by light-resistant, if light could affect the properties of the product.

There are three regulatory/industry guidelines typically cited in the U.S. regarding CCI testing:

  1. FDA Guidance for Industry (2008), Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
  2. PDA Technical Report No. 27 (1998), Pharmaceutical Package Integrity (not available for free)
  3. USP <1207>, Sterile Product Packaging – Integrity Evaluation

CCI testing is either physical (bubble, liquid tracer, vacuum/pressure decay, dye ingress, etc.) or microbial (microbial ingress).

Each has it’s advantages and disadvantages, as shown in the below from American Pharmaceutical Review:

When should these tests be performed? CCI testing is applicable to new container closure systems and can be performed on newly sealed containers to validate sealing performance, and then annually and at the expiration date to validate stability.

What are your preferred methods of Container Closure Integrity Testing?

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10 Easy Steps – Deleting a Point from a Qualified Building Management System (BMS)

Siemens APOGEE

Hello, good people of the world! This post covers the procedure for deleting a point from a qualified Building Management System (BMS), specifically the Siemens APOGEE® BMS. A template for your use is here: Deleting a BMS Point TEMPLATE.

  1. Deleting a BMS Point Continue reading 10 Easy Steps – Deleting a Point from a Qualified Building Management System (BMS)

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..