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Results for Cleaning validation

WEBThe acceptance criteria of cleaning validation studies should be based on HBEL Criteria, i.e. Health-Based Exposure Limits. The procedure proposed for the …

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URL: https://ask.pharmaguideline.com/t/results-for-cleaning-validation/7297

WHO TRS 1033 published in March 2021

WEBWHO TRS 1033 published in March 2021 can be downloaded from the provided link. It includes 11 newly approved Annexes. The most important of which are: …

Category:  Health Go Health

Health Based Cleaning Limit Calculation

WEBHello everyone, I found this formula for calculating product residues and I want to know if anyone else is using it? How is it working for you. Is FDA ok with this? …

Category:  Health Go Health

Standing Regulatory Members of ICH

WEBRup104 (Rupesh Patel Dept Of Pharma , Iit (Bhu) Varanasi) March 17, 2018, 6:58am 1. How Are Standing Regulatory Members of ICH different from founding …

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Why Fumigation is banned

WEBProduction. why Fumigation with formaldehyde is banned by different regulatory bodies? Corresive and due to the produce carcinogens with product and …

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In-Process and Bulk Drug Product Holding Times

WEBQuality Assurance. RYMpharma (RYM) April 20, 2021, 9:43am 1. Hello everyone. Can you direct me to the official text of the FDA which talks about the …

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Specific difference between FDA, MHRA, PICs and PDA guidelines

WEBcore of question not understood, regulatory authorities like US FDA, Indian FDA, MHRA, WHO, TGA etc. are working for respective country and region. they are …

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Health Technical Memorandu m 2010

WEBAbout this publication Health Technical Memoranda (HTMs) give comprehensive advice and guidance on the design, installation and operation of specialised building and …

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Autoclave requalification cycles

WEBNesreen (Nesreen) January 24, 2021, 5:40pm 1. What should i do when i have a temperature over shoot during the annual Autoclave re- qualification cycle? And what is …

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USP / BP compliance fo API

WEBDr.Prince (Dr.Prince Manta) July 22, 2018, 7:40am 1. Can API manufactures approval their product by mentioning USP/BP on COA. If their unit is not approved by …

Category:  Health Go Health

Integrity of Filter Integrity Test

WEBAndmentor (Andres) March 28, 2023, 2:06pm 3. Usually, during an inspection from a health authority (e.g. FDA, EMA, etc.), there is no need to prove that the information and data …

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DMF, CTD eCTD, Dossier

WEBThe API manufacturer must give the drug product manufacturer a Letter of Access allowing the Health authority where the DP is registered to review the closed …

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Validation for new AHU

WEBOnly for new two ahu. Sanket136 (Sanket kakadiya) June 13, 2018, 4:40am 3. Performe all AHU PQ bcoz area are modified. solankikishan885 (Er. Kishan Solanki) …

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Stability chamber validation

WEBStability. Sandeepmalyan (Sandeep malyan) October 5, 2016, 8:46am 1. What is the validation time of stability chamber & frequency of recording of temp & …

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Pharmaguideline Forum

WEBA discussion forum to help and answer the questions of pharmaceutical professionals.

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Piot batch, validation batch & commercial batch

WEBIn short: Pilot batch allows you to define the manufacturing process (parameters, controls, etc.), validation batches allows you to demonstrate that process is …

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Skipping test For raw material and packaging material

WEBQuality Control. micro.ezz (mohamed abdelrahman ezz) January 7, 2021, 7:59am 1. Dears. I wat to SOP For Skipping test for Raw material and packaging …

Category:  Health Go Health

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