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• Cleaning-Validation-Protocol.docx‎ (106.1 KB)

We have a suite which manufactures several Pesticide formulations with different actives.

Has anyone got any suggestions as to setting a MACO for this product.

Hello ,

I would like to know some points regarding the formulation of Zinc Gluconate Tablet , I want to use these ingredients for formulation:
Zinc Gluconate, di-Calcium Phosphate, Microcrystalline Cellulose, Crosslinked Sodium Carboxyl Methyl Cellulose, Veg. Steric Acid, Veg. Magnesium Stearate, Acacia Gum.

please help me if I want to make a tablet with 70 mg Zinc Gluconate powder (equivalent 10 mg Zinc elemental)

Thank you all,
jack

Dear all, i have a question about sterilizing tunnel validation. When conduct the Depyrogenation Test, which Z value（54 or 46.4 ） should i take to calculate Fh value （take 250℃ as basic temperature）？
Is there any guidelines or standards to define the Z value？
Appreciate for your reply.

I would talk about validation of laboratory equipment.
In my Factory, the QC (Quality Control) decided to entrust operations about IQ, OQ, software, to external contractor who executes IQ and OQ of laboratory equipments (for example spectrometer FTiR). At the same time it isn't executed any validation by internal QC System; I would like to know your opinion.
Is this approach correct for you?
Is it maybe necessary to execute internal validation protocols by considering that qualification of external contractor is not enough?
My opinion is that there is differences between qualification vs validation, is it correct?
May anyone suggest me GMP correct approach by regulations?
What is the Regulations to follow?

What would be the best approach to go from an "NC" space to a "C" class room regarding gowning and MAL's from validation point of view?

ICH sends Q11 guidance to regulatory agencies like EMEA, FDA & Japan.

http://www.ich.org/fileadmin/Public_...Q11_Step_4.pdf

I am process validating a Pour-On for the Europe Market, the active is 0.5%w/v and a dosing gun will be used for administration.

Do I need to test Uniformity of Dosage units, should this be done by CU or MV?

Dear All,

can anyone updates on the requirement of specific temp and humidity conditions for UK-MHRA and USFDA for the oral solid dosage form mfg faciility and the supporting guidelines or reference for that.

Thanks in advance,
Vishal

Dear All,
Some of our finished product must be stored in "Dry Place", the USP defines dry place as;

"Dry Place:The term “dry place” denotes a place that does not exceed 40% average relative humidity at 20 (68 F) or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place or may be based on reported climatic conditions. Determination is based on not less than 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value does not exceed 40% relative humidity. Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered a dry place."
I am not able to figure out if the store temperature is 25 C, which humidity is accepted at that temperature

Regards
Mohammad Khmour

Dear All,

Whether Separate Risk assessment to be done for DQ, IQ, OQ, PQ for autoclave

If so wat and all points to be considered at the time of DQ, IQ, OQ, and PQ

Thanks and Regards,
S.Raghavasimhan

Dear All,

Can we start Phase-I water validation prior to area qualification of main plant.

Regards

Prashant Mhetre

Hi Folks......proposal here to allow parametric release of devices post completion of sterilisation cycle. In the event of issues with the sterilisation cycle a proposal by team is to qualify the option of a second sterilisation cycle. Current process runs on ETO x 1 cycle. In the event of issues the products will be processed to a 2 x ETO.

Orignal process validations were completed post 1 x ETO.........what is standard practice out there if a second cycle is made available (this is a non-API device)? Is process validation reexecuted? Bear in mind that a repeat of design testing will be completed......

Would appreciated your thoughts!

Hello Friends,

For new autoclave we are planning to do risk assessment. I am new to this topic. I want to know something about FMEA and other risk assessment tools