Very informative video... Thank you sir...

Good presentation. How to classify pharma products under different oel class?

Sir how can I become auditor

Thank You Sir you are giving time to us

Sir Please guidance on astm e2709/e2810 guideline especially how to use excel sheet for BU and CU

I will attend the session

Sir

Hello

I have a question. The suppliers that we have not all want to colaborate to write this times. Despite the data loger, the container plastic seal, is there any system that we can integrate and buy to have this data that can truck the containers and the movemant process?? What is your experince ?? I have read some articles about systems with rabiowaves that can truck. Do you have any suggestion??

sir

Hello

I have joined

I will join

GE Sir

Good evening sir

Sir- Is individual rinse sample acceptable for cleaning validation or verification? Is there any guidelines requirement? Please give the reference of any.

According to ICH Q7 or other relevant guidelines, is it permissible to blend two continuous batches of API without testing the individual dried batches beforehand?

Sir what is the difference between 5th and 6th step both are same na sir

During cleaning validation time, which samples should be collected first: swab samples for microbiology, rinse samples, or swab samples for chemical residuals?

Please share the questions and answers

Thank You Sir Providing lot of information to us

Helpful and very nicely explain in short time

Is AMV required for those specifications and test procedures which are used during water system qualification.

Sir- As said please provide the reference link for each guideline.

Very helpful Sir..

Greetings. Thank you for taking the time to create this short teaching. Feedback - real-life industry examples would make this material more interesting rather than a rehash of the Agency's Jan 2011 Validation Guidance. Regards

Thank You arrange the training

Does ICH Q7 expect that the quality unit performs API release testing? Yes, ICH Q7 emphasizes that the Quality Unit (QU) must ensure that APIs meet established specifications and are released after thorough review and approval. However, the actual testing may be performed by a QC. Can other departments outside of the quality unit be held responsible for releasing raw materials and intermediates? No, the responsibility for the release of raw materials and intermediates lies with the Quality Unit, as per ICH Q7. However, other departments can assist in sampling, testing, and providing data, which the QU reviews before release. Should sampling be performed by the quality unit only? Not necessarily. sampling can be delegated to trained personnel in other departments under a documented and controlled procedure. Should acceptance criteria for residues be defined for dedicated equipment? Yes, acceptance criteria for residues must be defined, even for dedicated equipment, to ensure that carryover of residues does not impact product quality. Cleaning validation is required for both multi-use and dedicated equipment. Who is responsible for the issuance of batch production records? The Quality Unit is responsible for issuing and controlling batch Master and controlled production records to ensure they are accurate, complete, and reviewed appropriately as per GMP requirements. However after master documentation of the BMR or TDS department dedicated person shall be issue the Production records or test data sheet either through electronic or manual issuance.

Sir, my self Rajib As u told 12 times need to be kept. I m also preparing the dossier part and we are mentioning the exhibit batch no is already available at the site in the warehouse with control room temperature and that samples are more then sufficient considering 12 times. And in commercial mfg we use to keep 2 times.

Thanks Sir for giving more clarity on deviation concept

Yes

Dear sir Please try to prepare a brief video on F0 value for sterilizer and trend analysis by using a different types of charts like control chart pyrot charts etc.

Dear sir Please try to prepare a video on F0 value , trend analysis of EM Water by using a different type of control charts, pyrote charts.

To reduce the potential risk of their health they putting some physical work on their body to maintain health fitness

Very good explanation sir , thank you

Sir use mike for sound clarity.

Sir what about the OTC products inspection?

very informative session sir

Hello sir

Sir, You are improving your presentation skills, congratulations heartily!

Good evening sir

Sir is there any point in guidelines that CpV report is prepared only if 10 batches are manufactured for a particular product in a review period.

good morning sir, My name is pratap iam working in APL health care limited unit-IV as an.Asst.Manager in IPQA department i have 10+ years of experience in shop floor now i want to shift to CSV, i watched so many videos from your you tube channel still i am not getting clear cut idea about that so please do the one clear video with one case study of CSV if possible, otherwise please suggest me to how to prepare for that, thanking you sir..

Thank you for the presentation

very informative thank you sir

Sir can you make a video on audit by fda

Happy Deepawali Sir

Hi sir good evening

A great opportunity for me ...

Happy Diwali