Category Archives: PQ

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

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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Parts Washer Qualification – PQ

Parts Washer

This post is about Parts Washer qualification. This covers any manner of automated system that cleans parts out-of-place (Clean-out-of-place = COP). This includes process parts washers, glassware  washers, laboratory parts washers, etc. all of which may be termed COP washers.

The scope of a performance qualification of a washer is the performance of the equipment with defined recipe(s) and load(s). Be sure to capture the recipe and load configuration in the protocol prior to execution or as part of the execution itself. This is how the recipe and load configuration become “validated.” The recipe includes all steps and parameter values, and the load includes what parts or components will be washed and how they will be arranged. You’ll need to include a picture or diagram. Continue reading Parts Washer Qualification – PQ