Category Archives: Advice Provided
Developing My Writing While Helping Others
I am a microbiologist with over 15 years’ experience in the pharmaceutical realm. I have a strong interest in regulatory compliance and developing others. Recently I have been working closely with data security. I have an arty streak, have been a work place trainer and have an affinity for computers.
Lately I’ve been thinking of ways to share my knowledge with others outside of my cycling and science blogs and have decided to write 12 LinkedIn posts over 12 months. I will limit the post size to between 500 and 1000 words (1-2 A4 pages). Continue reading
Microbiological Trending of Environmental Monitoring Data
Microbiological trending of environmental monitoring data serves multiple purposes:
- Trending helps to define and hone your limits
- Trending helps to determine if control of your processes has been lost (or is heading that way)
- Trending helps to identify the effectiveness CAPA and process ‘improvements’
Does anyone use Evernote as an ELN (electronic laboratory notebook)?
The Question posed on LinkedIn:
“Does anyone use Evernote as an ELN (electronic laboratory notebook)?
Evernote seems to be a powerful, extensible cloud based application. I am curious if anyone in the group uses it in their lab and how do they use it, for what purpose and how well does it work for your needs?/”
My reply to this was:
I’d not advise it. Besides a vendor audit to ensure availability of the system and backups you’d need to ensure Evernote data cannot be obscured or changed, make sure time, date and user stamps are in place and the data integrity is maintained for the duration of the retention period.
Using MS Excel or MS Access for Tracking
The Question posed on LinkedIn:
“Quality Assurance of Excel-Tables or Access-Databases used for tracking Change Control Procedures , Deviations, or Complaint handling
While larger companies nowadays use validated systems such as Trackwise, SAP modules and the like for following-up on their CCPs, deviations, CAPAs etc., in GMP inspections of smaller companies I usually encounter some sort of electronic Access- or Excel-based lists that are used (typically by QA) for this purpose, i.e. entering cases, assigning event ID’s, and supervising the progress of investigations / implementation measures until approval / close-out.
These lists a quite critical, especially when many events have to be dealt with, a.o. because of the risk that certain events might get ‘forgotten’.
Nevertheless, I see quite often that little is done to ensure that entries in these lists are correct and uptodate. Another issue is controlled handling of hardcopies of these lists which often, not astonishingly, are outdated as soon as they come out of the printer.
Any ideas what it makes challenging to deal with these lists? What are proven good practices worthwhile to share?”
My reply to this was:
Just like for word, Excel has a revision tracking feature.
There are ways to log changes to tables data in Access, but none are particularly robust.
It all boils down to using the right tool for the job. Is Excel or Access a suitably regulatory compliant solution or do you need to use something else?
The last line of the my comment sums things up nicely.
TGA Inspection Trends
My reply to a post on LinkedIn.
Current TGA Inspection trends: This presentation will focus on the common types of deficiencies found by the TGA’s GMP Inspectors as well as some data on the number of inspections performed both locally and overseas and compliance rating outcomes for the inspections performed.
Comment 1 stated “…there are patterns that seem to repeat year after year. Poor QMS, inadequate investigations, lack of training.”
My reply to this was:
“The PIC’S guide to GMP stresses the need for a robust QMS and repeats over and over again the need for documentation, solid investigations and adequate training and retraining. It is a wonder why citations regarding a lack of these keep being given.” Continue reading
GMP Manual
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?
Environmental monitoring: viable particles
The Question posed on LinkedIn.
“Hi all, I would like to ask you about how to perform cleanroom microbiological environmental monitoring. Is it clearly defined in guides?
TSA and Sab at different temperatures or only TSA? If only one TSA plate, do you incubate at 20-25ºC and then at 30-35ºC, or only at one temperature?
Do you performe growth promotion test in same conditions?
Thank you for your comments!”
My advice:
USP <791> Environmental Monitoring Program Design and Application
USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments states “….time & incubation temps is made once…media have been selected. Typically…22.5 ± 2.5 and 32.5 ± 2.5…incubation time of 72 & 48 hrs, respectively. Sterilization processes used to prepare growth media for the environmental program should be validated &…media should be examined for sterility & for growth promotion as indicated under Sterility Tests 71. In addition, for the Growth Promotion test, representative microflora isolated from the controlled environment or ATCC strain preparations of these isolates may also be used to test media. Media must be able to support growth when inoculated with less than 100 colony-forming units (cfu) of the challenge organisms.”
So, pick your media. Test it. After that, validate your sampling recovery methods.
Air Shower Qualification
The Question posed on LinkedIn.
“Can any body guide me how to perform the air shower qualification in potent drugs manufacturing? Is there any guidance for the same? Which test needs to be covered during qualification? ”
My advice:
Having worked in sterile production facilities, I’d consider an air shower a bad idea (increased particulates, impact on pressure differentials, ineffective removal of static particles (even creation of static particles) etc risk of forcing particles through PPE onto operator, cross contamination of surrounding de-gowning area/airlock).
I’ve found an old (2002) article that might help you with any URS and subsequent validation activities you develop:
https://www.alnmag.com/article/2002/12/how-do-air-showers-fit-contamination-reduction-plan
There are also two old (1999 and 2002) references at the end of the (linked) article.
Data Retention
My reply to a post on LinkedIn.
“When choosing Cloud vs on-premises, we need to be reminded that a “no decision” is a decision and the risk should be assessed. ”
My comment:
A good reference for such data’s retention is the FDA’s Guidance for Industry 21 CFR Part 11; Electronic Records;Electronic Signatures; Maintenance of Electronic Records.