Transfer Machines From Penicillin area to none Penicillin area

GOOD MANUFACTURING PRACTICE (cGMP)
1

What are the requirments to be followed to transfer the machines from penicillin area to none penicillin area if I cleaned well the machine.
BR
Eid

2

Cleaning thorough decontaminating the entire equipment with the established validated method that removes the contaminants.Various chemicals are emloyed for the process & one can be used by cleaning with 10% NaOH solution.

3

If decontamination done satisfatorily & also being confirmed,then there is no stringent requirements,just follow the normal course of shifting.

4

Dear Dr, Eid

for this process, you have first to concentrat on the cleaning validation and the detection acceptance limits for cleaning validation. then if your equipment are qulifide you have to re-qualified them again.

many thnaks

jalal abed al ghani

head of validation

mobil # (0799500074)

5

It is better to have separate facility for pencillin products, otherwise u will face lot of problems in USFDA audits.

6

Dear All,
There were some discussions on Pencillins issues previously. The same can be found at cGMP Notes.

You can also download the same at the following link.

7

Dear All,
I appreciate Mr.Noor for providing a good information on Pencillin Issues.

I have some questions, about the cleaning of equipment for this case…

a) Where do we clean the equipment? Pencillin / Non-pencillin facility?

If the cleaning is done in Pencillin area, how do we transfer the equipment into non-pencillin facility?

If we clean the equipment in pencillin area and getting the limit of Less than 0.006 ppm (as per the cGMP notes), then again we need to clean the equipment in non-pencillin area and we will get the problem of transfer…bcoz it contaminates other areas of this non-pencillin facility…

NOTE: a) We require the detection limit of less than 0.006 ppm for HPLC system.

b) We require a separate cleaning validation for this case…and triggers lot of questions during Regulatory agencies audits.

b) How to transfer the equipment… and what procedure we follow, when we transfer. Because, we need to have a procedure for handovering the equipment to non-pencillin area personnel. For that, pencillin personnel can not enter the area of non-pencillin areas…

NOTE: It requires a Company Policy / Corporate Procedure which includes Transfer of Equipments, Accessories, Material, Personnel, Documents…

c) Does bio-assay required validation, for detecting the traces of pencillins (plz check the below mentioned statement of cGMP Notes)…then how to link it with Cleaning validation. Because, in cleaning validation, we don’t rely on bio-assay.

cGMP Notes:
The bioassay referenced in 21 CFR 211.176 can be used whenever there exists a reasonable possibility that a non-penicillin drug product has been exposed to cross-contamination with penicillin. The non-penicillin drug product should be tested for the presence of penicillin and not marketed if detectable levels are found when tested according to procedures specified in “Procedures for Detecting and Measuring Penicillin Contamination in Drugs”, which is incorporated by reference.

So, what I understood is…better we dedicate the facility & equipments of pencillins, to that only.

With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com

8

It is better to have separate facility for penicillin and non-penicilline. It is very difficult to satisfy auditors,specially USFDA.

i think major issue will be cleaning,because cleaning procedure for penicillin and non-penicillin facility is all together different…

Prasad Aparajit
Nicholas piramal