More than one analytical laboratory within a company without clear definition of responsibilities and goals creates issues. This is particularly true if these labs are at different sites, but can also occur if they are within the same site. This can function satisfactorily if these different labs are part of one organization under the same head. However, without this each lab has its own responsibilities that are usually separate from the common goal.
Without a common head of the labs that these separate labs report to, the labs will typically go their own directions with regard to SOP's and how they plan to implement cGMP's. This includes instrument selection in order to facilitate method transfers and equivalency of testing. This is a case where one lab has all HPLC's while a newer lab starting up chooses to implement newer technology in purchasing UPLC's. One site may be more development oriented, while another is more production oriented. The lab that is more development oriented may have little interest in fully implementing cGMP's. Yet, when it comes to releasing clinical supplies, the development lab may be the only lab that has the necessary methods to test these products. Then the question comes up whether the appropriate standards have been implemented.
In the case of 2 labs conducting QC testing, there may be a difference in rounding and reporting results, particularly when it comes to impurities. These minor differences may not seem like much, but it is likely that if an auditor picks up on these differences the logical question is why are the 2 labs performing differently and which is right.
If it is possible for the different labs to come to an agreement on who will do what, how will cGMP's be implemented, which SOP's will be implemented (wording and language included depending on country), and what are the priorities?
It may, ultimately, make sense to have local laboratories with the R and D or production facilities. Responsibilities must, however, be clearly defined. It is unrealistic for different sites to constantly have to coordinate testing of products and materials. It is much better to have all of one type of testing at one site, a local manager at each site, with all analytical labs reporting into one Director.
Without a common head of the labs that these separate labs report to, the labs will typically go their own directions with regard to SOP's and how they plan to implement cGMP's. This includes instrument selection in order to facilitate method transfers and equivalency of testing. This is a case where one lab has all HPLC's while a newer lab starting up chooses to implement newer technology in purchasing UPLC's. One site may be more development oriented, while another is more production oriented. The lab that is more development oriented may have little interest in fully implementing cGMP's. Yet, when it comes to releasing clinical supplies, the development lab may be the only lab that has the necessary methods to test these products. Then the question comes up whether the appropriate standards have been implemented.
In the case of 2 labs conducting QC testing, there may be a difference in rounding and reporting results, particularly when it comes to impurities. These minor differences may not seem like much, but it is likely that if an auditor picks up on these differences the logical question is why are the 2 labs performing differently and which is right.
If it is possible for the different labs to come to an agreement on who will do what, how will cGMP's be implemented, which SOP's will be implemented (wording and language included depending on country), and what are the priorities?
It may, ultimately, make sense to have local laboratories with the R and D or production facilities. Responsibilities must, however, be clearly defined. It is unrealistic for different sites to constantly have to coordinate testing of products and materials. It is much better to have all of one type of testing at one site, a local manager at each site, with all analytical labs reporting into one Director.
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