Cleaning Validation

Submitted by aravindsai41 on Sat, 01/15/2011 - 04:05

               Webinar on validation-articles" class="alinks-link" title="pharmaceutical cleaning validation">Cleaning Validation

Webinar category: QA/GMP/Regulatory Affairs

How clean is Clean ?

“validation-articles" class="alinks-link" title="pharmaceutical cleaning validation">Cleaning Validation is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing of pharmaceutical products or active pharmaceutical ingredients (APIs).” – PIC/S

Cleaning validation is assuring that the cleaning procedures are working.

Importance of cleaning validation:

  1. To ensure no cross contamination
  2. A Regulatory requirement.
  3. Assures quality in product being manufactured.

This webcast covers:

  1. Cleaning validation introduction.
  2. Elements of cleaning validation protocol.
  3. Recommendations for carrying a cleaning validation.

Webcast by

Aravind Sai, M.S (Australia) and Pradeep Mahakala , Deputy manager at Gland pharma , Hyderabad.

 

Download
Sample Cleaning Validation Protocol
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Comments

praveen kumar tavva's picture

praveen kumar tavva

Sat, 01/15/2011 - 11:56

Its good. i am waiting for Jan 20 to attend this workshop......
Ankur sood's picture

Ankur sood

Sat, 01/15/2011 - 17:14

it is excellent . i am excited for attending this workshop.
dvsnaditya's picture

dvsnaditya

Sun, 01/16/2011 - 01:51

Some thing different, but very important for practical skills, eagerly waiting for 20th jan

Regards,    D. V. S. N Aditya   

Event co-ordinator RCP
jagadeesh jaggu's picture

jagadeesh jaggu

Sun, 01/16/2011 - 06:14

Iam so eager to participate in such programmes because it is so helpful to our future carrier & also we can get good knowledge over the validation process once again thanks a lot for conducting this kind of programmes sir...
jagadeesh
mridula's picture

mridula

Sun, 01/16/2011 - 14:10

just waiting for this workshop to start.
mridula jayaraman Pharma Wings
vanajaponnaganti's picture

vanajaponnaganti

Mon, 01/17/2011 - 07:32

i m waiting for this webinar on cleaning validation
cyril rai's picture

cyril rai

Mon, 01/17/2011 - 09:45

wanna atend dis....
cyrilrai
jitendrakumawat26's picture

jitendrakumawat26

Mon, 01/17/2011 - 13:12

i am waiting
jitendrakumawat26@gmail.com
sharath chandra's picture

sharath chandra

Tue, 01/18/2011 - 07:24

first of all let me thank aravind sir for organising such workshops and webinars which are very useful for the students.Eagerly waiting for the webinar....Warm wishes..... sharad.1486@gmail.com
swaroop kumar's picture

swaroop kumar

Tue, 01/18/2011 - 14:05

first of all let me tell thank to aravind sir & Pradeep Mahakala sir for organizing this type of workshops and webinars which are very helpful for the students & research scholar.we are waiting for this workshop.

swaroop kumar

leela's picture

leela

Tue, 01/18/2011 - 14:47

Thanking you sirs for spending your invaluable time for us and for your great concerns
Harsh bansal's picture

Harsh bansal

Wed, 01/19/2011 - 18:00

hello sir, its really good part of knowledge. its very good for us... thank you

harsh bansal

mukulkogata's picture

mukulkogata

Thu, 01/20/2011 - 07:36

it will be really very knowledgeable. Thanks
Mukul Kogata
Ankur sood's picture

Ankur sood

Thu, 01/20/2011 - 16:56

hello sir, IT IS A NICE PRESENTATION. , WITH REGARDS ANKUR
rabia naveed's picture

rabia naveed

Fri, 01/21/2011 - 09:38

very informative presentation..

rabia

mridula's picture

mridula

Wed, 01/26/2011 - 09:39

Dear Sir, Thank you for giving us an insight into what should 'real cleaning validation be'. This would help us while we join any industry or quality control experts in some organisation. Can I add one thing to this Sir? For manual cleaning validation process, not only supervision is necessary as sometimes the supervisor can also commit some mistake as human error is always possible in any field. So 'test checks' by authorised persons into the manual cleaning validation process would yield better results not only in terms of accuracy but also in terms of the fact as to whether the person who is doing the validation requires any training or the supervisor is competent enough to supervise. Test checks can also be done in automated process also just to see whether it is working properly. Do you agree Sir? Regards,
mridula jayaraman Pharma Wings
aravindsai41's picture

aravindsai41

Wed, 01/26/2011 - 09:42

Thats what we tried to say in the last slides, about analysis.
regards, Aravindsai
mridula's picture

mridula

Wed, 01/26/2011 - 09:46

Dear Sir, Thank you very much, Regards,
mridula jayaraman Pharma Wings
jaiseema's picture

jaiseema

Wed, 01/26/2011 - 13:02

Dear Sir, I am a lecturer. Sometime chromatographic results of our students are not upto the mark because of error due to the cleaning process not done properly. Our students also do not understand the importance of proper cleaning of apparatus etc. Only when they learn the procedure properly in college, they can apply it to the industry which they join. Your presentation has just demonstrated that. You have clearly explained all the aspects regarding the issue. However, Sir, do add some comments as to what our students should do in their college life also so that they are prepare to validate when they become professionals so that your message gets conveyed to them in a clear cut and precise form and they learn from it. Regards,
thanks SEEMA MEENA
aravindsai41's picture

aravindsai41

Thu, 01/27/2011 - 00:35

The principles doesn't change though it is a university laboratory or industrial. Implementing cleaning validation at college is a challenge, but not impossible. IMPACT: Major impact is "cross contamination" if the cleaning is validated. As a result the chromatographic results will be of contaminated product rather than of the product you are trying to measure. To do a cleaning validation at your laboratory suggest your students to: 1) Calucalate Maximum allowable carry over (or how much residue of the earlier process would impact the results of the next experiment) MAC check this link. http://blogsdm.files.wordpress.com/2009/11/4921944-taking-the-mystery-ou... 2)Considering the equipment design, define the sampling points. 3)Conduct analysis of cleanliness with suitable equipment available in your laboratory. "However to document your cleaning validation you need follow all the recommendations explained in the presentation".
regards, Aravindsai
jaiseema's picture

jaiseema

Thu, 01/27/2011 - 06:53

Dear Sir, Thank you very much for your valuable information using which our students will definitely benefit. Regards,
thanks SEEMA MEENA
Barkat Khan's picture

Barkat Khan

Tue, 11/29/2011 - 18:49

Dear Sir i think its a very basic and informative information on this kind of topic. barki.gold@gmail.com
Barkat A Khan PhD