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Pest control regulations for pharmaceutical manufacturing companies?


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#1 jursico

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Posted 23 January 2013 - 09:52 AM

Hi,

sorry if I'm not in place with my question. Is anyone aware of the up-to-date pest control guides/regulations for pharmaceutical manufacturing companies? Lately there were some new and quite important to follow requirements for food industry. Can we rely on those as the highest standard?

Thank You!



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#2 Charles.C

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Posted 23 January 2013 - 02:08 PM

Hi,

sorry if I'm not in place with my question. Is anyone aware of the up-to-date pest control guides/regulations for pharmaceutical manufacturing companies? Lately there were some new and quite important to follow requirements for food industry. Can we rely on those as the highest standard?

Thank You!

Dear jursico,

Welcome to the Forum ! :welcome:

Nice to get a post from Lithuania, first one i can remember.

Lately there were some new and quite important to follow requirements for food industry.


Can you clarify which requirements you are referring to ? :unsure:

Rgds / Charles.C

Kind Regards,

 

Charles.C


#3 jursico

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Posted 23 January 2013 - 03:07 PM

Dear jursico,

Welcome to the Forum ! :welcome:

Nice to get a post from Lithuania, first one i can remember.



Can you clarify which requirements you are referring to ? :unsure:

Rgds / Charles.C


Thank you for welcoming onboard :smile:

I have in mind those mentioned in Acheta article (attached, marked in red). They are not quite new actually but our pest controller (Rentokil group) started to implement them just recently for their local clients.
We've had external audit at our plant and some observations regarding trend analysis, more specific reporting, etc. We need to update our local pest control SOP, so I started to look for the guides that inspectors referred to. Contractor is offering field biologist service but I am not sure if it is obligatory for us and will be exactly what we need to improve ;)

Attached File  The_Acheta_guide_to_pest_control_compliance_with_BRC_6.pdf   857.61KB   141 downloads

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#4 john123

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Posted 23 January 2013 - 04:03 PM

Reading what you highlighted, I'm not seeing where a field biologist would be required and I can't see what it might help determine. We handle the majority of our pest control in house and it doesn't look like this standard would be too difficult to meet.



#5 Shyguy77

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Posted 23 January 2013 - 09:06 PM

Others have posted on the forum as how to meet the standards of BRC 6. Im not sure if these are highest standards, but this link shows what others on the forums have been doing to meet the standards you posted with the Acherta Guide.


http://www.ifsqn.com...-how-to-comply/



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#6 Charles.C

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Posted 24 January 2013 - 05:29 AM

Dear jursico,

Thks yr useful attachment.

I hv added some more (earlier) links below to maybe relevant threads here.

As you say, the interpretation of "expert", (eg XYZ Biologist) in section 4.13 has been a major (?) issue in current BRC food standard. It is obvious that auditors are exhibiting at least 2 major geographical variations in interpretation, ie UK/USA from where most of the posted input here has derived. UK auditors seem to have chosen to be very "diligent", USA more flexible (eg prev. quoted thread). It appears that "Lithuania" is following UK line (maybe also related to the service contractor?). Would be interesting to get more locations ?? :smile:

Operational variations seem to have also been foreseen in yr (UK oriented?) attachment's comments. I noted that compliance to the second standard mentioned in yr attachment is also recommended to include Field Biologist aspects although not actually specified. Basically the attachment looks to be taking a conservative viewpoint in advance of practical data which i suppose is understandable (??).

I have no idea how the expectations compare to other, specific, Pharmaceutical Standards but if the "borrowing" has become a general procedure, i am offhand not too surprised at an ultra-conservative interpretation but, in truth, who knows ? Is the contractor applying identical interpretations to all food companies also ?

Maybe there are no Field Biologists in Lithuania so > Money issues also ?

http://www.ifsqn.com...dpost__p__55426

http://www.ifsqn.com...-expert-survey/

http://www.ifsqn.com...ontrol-surveys/

Rgds / Charles.C


Kind Regards,

 

Charles.C


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#7 jursico

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Posted 24 January 2013 - 07:45 AM

Dear Charles.C,

thank you for the links, will spend some time browsing there :smile:
I will try to clarify what exactly I am trying to figure out. Our contractor says biologist inspections are mandatory for food producers and they offer this service but they are not aware if it is obligatory for pharmaceutical companies as our national regulations in this field (pest control) are a total mess Posted Image . We are following national standards, GMP guides, FDA regulations, not sure about the rest (I am not QA). If biologist inspections is a requirement then probably they could perform pest activity trend analysis, more detailed reporting and thus we comply with observations of the recent audit (Japanese). If not, probably we could do this ourselves. I need to define that clearly in our SOP and give references to the guides. Also, not sure about the trend analysis - is it a regulation or recommendation?

Dear john123,

biologist is a requirement as I can see in Comments (page 4). Unfortunately, couldn't find to read and check BRC itself. Other requirements are ok, we are following. Actually, our contractor performs general inspections quarterly (besides regular ones twice a month) but they are carried out by their technician, not biologist.



#8 Charles.C

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Posted 24 January 2013 - 08:15 AM

Dear Charles.C,

thank you for the links, will spend some time browsing there :smile:
I will try to clarify what exactly I am trying to figure out. Our contractor says biologist inspections are mandatory for food producers and they offer this service but they are not aware if it is obligatory for pharmaceutical companies as our national regulations in this field (pest control) are a total mess Posted Image . We are following national standards, GMP guides, FDA regulations, not sure about the rest (I am not QA). If biologist inspections is a requirement then probably they could perform pest activity trend analysis, more detailed reporting and thus we comply with observations of the recent audit (Japanese). If not, probably we could do this ourselves. I need to define that clearly in our SOP and give references to the guides. Also, not sure about the trend analysis - is it a regulation or recommendation?

Dear john123,

biologist is a requirement as I can see in Comments (page 4). Unfortunately, couldn't find to read and check BRC itself. Other requirements are ok, we are following. Actually, our contractor performs general inspections quarterly (besides regular ones twice a month) but they are carried out by their technician, not biologist.


Dear jursico,

I think you will find BRC6/Food does not mention "biologist", only expert, see this (UK origin) post in post # 5's referenced thread - http://www.ifsqn.com...dpost__p__56670

But it was apparently mentioned in BRC's "guidances".

Hence some of the the issues. :smile:

The tabular content of BRC6 is summarised within a so-called "BRC self-assessment checklist tool" (available here somewhere and used to be freely available on BRC website, not sure if currently there.) The (pest control) material in yr attachment looks quite comprehensive to me.

Rgds / Charles.C

Kind Regards,

 

Charles.C


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#9 Charles.C

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Posted 24 January 2013 - 01:11 PM

Dear jursico,

Some additional to previous post -

You queried what requirements as stated by yr contractor were mandatory.
This necessarily relates to the choice of standard used as a reference.

For example, i attach below the pest control requirements / suggested related guidance procedures of another well-known FSMS standard, SQF2000 (this is previous version to current [issued 2012] but the list looks very similar to me although I am not a user).

I see no sign of the "Expert/Biologist" function in SQF :smile: . BRC also tends IMO to be considerably more explicit in demanding details of every aspect of the operation and is well-known for its annoying fascination with asking for "risk assessment" frequencies wherever possible (eg 4.13.8). Otherwise the differences are perhaps not that great, eg trend analysis is explicitly stated in BRC but also implicitly expected in SQF also (according to Guidance notes anyway). [I daresay both standards' originators watch each other to some extent :smile:. ]
If anyone here is using both standards they are welcome to agree/disagree/expand my opinion. A detailed comparison may already exist on this forum somewhere ?.

One continuous bonus in using a reputable contractor is that it automatically transfers/solves a lot of the basic requirements, at a price. In your specific case I expect (cynically) that the expert/biologist issue is regarded as a business opportunity but maybe there is no option unless you wish to launch a probably (?) non-simple project to do it on yr own (or seek a contractor with a more amenable reference standard of course.) This presumably depends on local capabilities / cost again.

I noticed there is a lot of competition for Pharmaceutical Production / Vermin Control on the net, looks like a profitable area. :biggrin:

Attached File  sqf 2000, pest control, requirements-guidance.png   387.66KB   24 downloads

Rgds / Charles.C


Kind Regards,

 

Charles.C


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