Tag Archives: GMP

Questions on Cleaning Validation Swab Area

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The Question posed on LinkedIn: (seems to be a dead conversation now).

“In a cleaning validation program, Which swab area is preferred ?

In any cleaning validation program, two common sample methods usually used.
One is rinse sampling and the other is swab sampling.
For swab sampling, some companies choose to use a 25 cm² swab area, others are using a 100 cm².
As per my limited info, no regulation ask to use a specific swab area.
But since you choose to use one of them, there must be a scientific rational/ justification, right ?

is it because, the larger is your swab area, the greater residues you can swab and recover ?

practically, some factors affect and effected by determining a swab surface area, Like ; recovery, the swabbed equipment part, residue limit..etc.

so, what is yours ?

“

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Questions About What To Do With Lids When Air Sampling

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The Question posed directly:

“Hi. I have a cleanroom question. When collecting an air sample with an air sampler device can you put the impactor head down when changing the plate.  Can you put the lid of the plate down when you change the plate.  What do you do with the two lids when changing the plate as I thought you could not put them down.

Thanks“

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Questions on Depyrogenation and Viable Environmental Monitoring

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The Question posed on LinkedIn:

“Hi all, I need your support to find the answers of the following questions:
1. Using manual cleaning of glass vial before sterilization in dry oven in aseptic process for lyophilized product which means no depyrogenation , is it acceptable? and if yes, what is the requirement that should be provided to the inspector as evidence of no contamination (as documents / studies/ gown).
2. Is it mandatory to conduct viable and non-viable monitoring in the ascetic process during the capping and crimping?
Thanks in advance…“

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Question on Microbiological Testing of Finished Goods

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The Question posed on LinkedIn:

“I have a question on microbiological testing of finished goods. We normally do TCP and Yest and Mold, however some customers are saying that pathogenic bacteria test is required after an enrichment is done. Is this really necessary if the PET passes and the TCP and Yest and Mold are less than 10 cfu?”

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Notes on PIC/S Guide for Good Manufacturing Practice for Medicinal Products (2009)

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When I was working in the sterile pharmaceutical industry, I reviewed the The Australian Code of Good Manufacturing Practice for Medicinal Products (2002) as part of my self-development.  This code was  revoked effective from 1 July 2010 and replaced by the PICS Guide for Good Manufacturing Practice for Medicinal Products 2009, as adopted in Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009.  Here’s the original review.

I have now reviewed the PICS Guide for Good Manufacturing Practice for Medicinal Products 2009, from the stand point of a microbiologist working collaboratively in a sterile pharma plant.  What my review does is make note of the salient points and I add comments to some.

Both the revoked 2002 Australian GMP code and the 2009 PICs guide are based on ICH Q&A Good Manufacturing practice Guide for Active Pharmaceutical Ingredients which was last modified in 2000.  In 2015 21 pages worth of clarifications were published to clear up some technical questions and to remove ambiguities.  Looking at them, I’m not sure why clarification was needed as they all seem straight forward and answerable by anyone experienced working within a pharmaceutical manufacturing environment.  This means that despite having “no recent experience” as deemed by some potential employers, my knowledge is still bang up to date. Combine that with my fantastic memory and impressive technical skills and I’d be an asset to your company. Continue reading →

GMP Manual

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The Question posed on LinkedIn.

“Dear experts..
Is there any links to get the chapters of the GMP manual ?”

My advice:

The ICH link is good as you’ll be able to download the documents various GMP guidance such as PIC/s recommendations and regulatory guide lines such as the Aust Code of GMP (as an example) are based on.

You can then find valuable information on recommendations from sources such as the FDA, eg http://www.fda.gov/downloads/Drugs/…/Guidances/ucm073517.pdf

So we might provide a less general answer, what specifically are you looking for?

Notes on Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002)

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When it was current, I reviewed the Australian code of good manufacturing practice for medicinal products (16 August 2002) so I was aware of the pertinent details in relation to viable environmental monitoring and testing.

The Australian Code of Good Manufacturing Practice for Medicinal Products 2002 was revoked effective from 1 July 2010 and replaced by the PICS Guide for Good Manufacturing Practice for Medicinal Products 2009, as adopted in Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009. The 2002 GMP Code for Medicinal Products remains available here for comparison purposes. Continue reading →