Process Validation Regulatory & Practical View
ฝัง
- เผยแพร่เมื่อ 17 ก.ค. 2020
- This training session will help you to understand process validation requirements as per EU,USFDA,TGA,ANVISA and WHO guide. Further will take through the common expectations from different regulatory guides. You will get answers for different questions like- What is difference in requirement of EU and FDA?, What are common errors made during process validations?, Exact difference between continued process verification and Product Quality Review? etc. This training session will provide overall insight about process validation strategy & designing the process validation protocol with practical approach.
Cadila, Sanofi,Zydus, AstraZeneca,Mylan,Interview Questions with Sharma Ji,ASK Mechnology,emainfo,Qualistery - GMP Content,easy medical device,AA. Vedic Gyan. KD,PHARMA PORTAL,Prof.Karan Ajay Gupta,Pharma Pill,Vivekanand Education Society's College of Pharmacy, - วิทยาศาสตร์และเทคโนโลยี
After 1 year I can hear you and can see your screen. And I can see you too. Your voice is outstanding
It's really great. Thank you for your kind message.
Thank u very much sir for detail explaining the guidelines and requirements
Welcome. Keep Learning !!!
Best presentation
Help me to known more about process validation
Thanks sir
Sure. Keep Learning !!!
I appreciate your efforts sir, thanks for this type of informative webinar
Thanks and welcome
Thank u so much. The way explain about EU and US guidance is very good sir.
Thanks
We appreciate to you sir ,it was the nice training and learnt lots of about same topic
Thanks. Please keep learning !!!
Thank you, really good presentation
Thank you so much for your kind comment. Keep Learning !!!
Yes
Thanks
Hi sir i just have one doubt could you revert,in which stage are we doing our validation of newly introduced product ..
Which stage means? Newly introduced product should be done prospectively. i suggest you can further elaborate your question.
Thank you sir for very informative Training
Thanks. Please keep learning !!!
Thank you so much sir, your videos are very informative n helpful 🙏👍 also would u please prepare video for post approval changes for US & EU
Sure. Will prepare on it.
Process validation comes under process design....?
Excellent
Thanks
Thank you so much sir this video is very useful for me and moreover if you don't mind please make one video for fishbone diagram and five why concept..thank you sir...
Sure. I will prepare. Thanks
I am a big fan of u sir
Thank you. Please keep learning !!!
Helll sir
Namasthey
Myself prasanna kumar.
Your class is absoluetly awesome.
Sir one topic might be easier to all but dont know why that never fed in my mind perfectly .
that is cp cpk pp ppk
Difference between them all
Weighing balance calibration
Criteria for selection of standard weights.
Equipment qualification
False tree analysis
Risk for Software updation
Tq sir
Thank you for suggesting the topics. I will definitely take training on these topics.
Dear can you please explain me
When we perform BU Sampling
Manny time I found some people tabbing sampling rod inside the bland for properly fill die cavity. But even if the die is not fill properly, then it goes out of the way and put it back into the blend, and again the samples come back from the same place.
I think doing this can cause a bland disturbance
Is that correct way.
Because we do die selection on the basis of bulk density
My question is very big, so please explain in detail
I hope you make a presentation video on BU and stetified sampling.
Thanks
Sure. Will prepare complete detailed video on it.
Dear sir
I just want to know
If we have one validated product #ABC on machine ex.glatt autocoater.
We have same other auto coater same make modal
Can we take #ABC batch on other machine on the basis of risk assessment.
Please suggest.
🙏🏻🙏🏻
Yes. You can perform QRM, check the impact and make sure that, the change in equipment will not impact on variability of the product.
Sir second query is about hold time study.
Manufacturing sites done hold time study. But as per practice hold time study sample do not check for stability study means long term impact was not assessed.
However based on hold time study during routine manufacturing of product holds in between stages such as between granulation & compression .
It this practice ok
I have observed OOS for moisture and temperature sensitive product in which holding during mfg was done .
FDA raises the concern about specific samples for HTS. It is recommended to keep the whole batch for HTS. So that, the same batch can be charged on stability study.
Dear sir, All topics covered in your webinar, apart from marketing complaint and Product recall.
Can you pls take a webinar on Marketing complaint and Product recall.
Sure. Will take in future.
Good sir
Thanks. Keep Learning !!!
Sir one of my question is if we have process validation for domestic market and is it process validation required for export batches if only grade change of raw material s
We need to evaluate in detailed. Please check - Whether any formula is changed. Specification of RM and FP is changed, Any equipment or batch size is changed? Any manufacturing process is changed? Please enlist the details of changes to evaluate.
Sir, what will source for rationale as in MFR there is no rationale provide d, what could be the supportive document
Can you please clarify your question again. Sorry but I am not able to understand. Thank you for sharing question again.
sir ...please make a vedio on sampling procedure in integrated line of granution used for manufacturing of hazardous product...like oncology product....because due to personal safety equipment can't open..so how to done sampling at different locations..
Sure. Will prepare separate video on it.
Sir...one batch can be taken for process validation at first commercial order after 1 or more years of exhibit batches (3 batches)
Can you please elaborate your question in detail.
I have two products with different brand name, but formulation is same, only new pack profile is introduced, I have to perform process optimization and process validation from packing stage. Primary packing material of both brand is same in all respects, can I prepare a common protocol for both brands?
I suggest you can go through the same recorded webinar in detail. you will get your answer. I need Just one clarity- do mean to ask for packing process validation or mfg process validation? Further whether the packing configuration is changed?
@@hitendrakumarshah3718 Sir only packing validation, pack profile of both brand is same, MOC is same, vendor of primary packing material is same,
@@snwani9109 Yes. I do agree. But, if the different packs are for different customer or different market, it is good practice to prepare separate protocol otherwise both validation will come in picture every time during the audit. Hope, you got my point.
We are following revalidation criteria for change in equipment, facility, process, KSM supplier etc. If CPV apprach is followed then is there requirement of revalidation?
Yes. you need to have revalidation approach.
@@hitendrakumarshah3718 Thank you Sir
@@ulhasdesale2363 Welcome Keep Learning !!!
dear sir suppose my API KSM input range is 150 to 200. does it mandatory to validate with 3 batches with 150kg , 3 batches with 200kg and 3 batches with 175 kg
Yes. It depends on case to case to basis.
Thanks sir for making such informative video.
I am a big fan of yours.
I gained some knowledge too from your videos. But, i can't apply these in my job profile as here I am working in Hyderabad based formulation company in packing department (Blister & bottle line) as an associate (Consider it as an operator). I am a B.Tech graduate in Mechatronics stream working since 2 & half years. But, i want to work in process validation area.
Sir, please suggest me the way to switch from my profile to process validation as it's seems difficult because I don't have hands on experience in that.
Waiting for your reply.
Yours obedient.
Manish singh
I suggest to learn the topic completely which you are interested. for example - process validation. involve yourself for discussions or investigations related to failures. During appraisal, you can speak with your head and HR about change in job profile. For further support, you can go through all topics and feel free to put your questions in comment section.
@@hitendrakumarshah3718 Thanks for your reply sir. It's really a nice gesture of yours.🙏
Hi sir, my question related to API vendor qualification during process validation. Is it necessary to perform process validation if API vendor change the manufacturing location to make API... Meanwhile API SOURCE and manufacturing process of API preparation is same. Vendor already qualified by RA but the vendor change only manufacturing location??
This change should be evaluated. Whether the change will impact on product quality? or CPP or CQA?
Packing validation required at submission batches mfg...?
As, the packaging material will likely to change in commercialisation, You can consider finished product testing. You can consider some basic tests but title should be process validation only.
Nice presentation.
During compression validation if we go for high hardness test then thickness value will go outside the limit. if we go for a low hardness test then thickness also come out of the limit. What to do in those circumstances??
First you have to evaluate which is your critical process parameter? If Hardness is CPP, and thickness is non CPP, by following deviation procedure you can handle. But, if your CQA is thickness, you should not cross the CPP.
Hitendrakumar Shah Thanks for your reply but both hardness and thickness are considered as a CQA I cannot choose either of them so how to balance both the things in validation.
@@janmejaypatel9915 I think, hardness is CPP for you and Dissolution will be CQA. The thickness due to slight change may not impact on product quality except may create difficulty during packing. Actually, this aspects should be studied at development stage only because, the hardness and thickness limit will be given to you by development only. Development should evaluate whether the thickness will be within limit or not if hardness is maintained within design space. At this moment, you can evaluate the above case for your product and accordingly raise deviation. This problem need to be investigated through deviation so that at least next time, your development team should able to concentrate this aspect before technology transfer. Hope you got answer to your question.
Hitendrakumar Shah Yes Sir Thanks
Thanks sir same situation occurred in our manufacturing so I get the answer from you.
Sir prospective validation batches can be marketed for sale and why revalidation is done when we have concurrent validation ????
I think there some confusion. I suggest please elaborate your question in detail so that, I will able to reply properly.
Can be release pre validation, optimization batch shall be release for market selling if yes so kindly provide guideline referance
The answer is Yes. It need to be evaluated case by case basis. Only after complying to respective specification.
Sir I have query regarding process validation.
Blending process need to validated 10 rpm, 12 and 15 rpm,
Option 1- operator run the blender for 10 rpm take out sample thn run for again 2rpm and takeout sample and again run for 3 rpm and take out sample.
Option 2- in rnd batch divided in to three lot and blender run on lot for low, other for optimum & max rpm.
Which is correct procedure.
Option 1- is not correct at all. During validation, we are not supposed to do optimization. . I suggest, you take the engineering/optimization batch and evaluate it.
Dear sir more thanks but only one question
How to implement and how to carried out with how many batches for continuous verification
I suggest, I have explained the details in this video. You can again go through the same. I think, may be in Q&A session.
What if pv not done on consecutive batches..what is meant by consecutive..if i am manufacturing 1 batch today, second batch after 4 months and third batch after 1 month of second batch...same is acceptable or not
This is consecutive. For PV consecutive batches should be considered.
First three validation batches there is BMR filling required or not?
Yes. of course.
Sir can you please help to prepared cleaning validation protocol of ointment manufacturing vessels and clean equipment hold time study protocols
Hi sir,
Please provide a training on US FDA 21 CFR part 820.
Sure. Thanks for your suggestion.
Is this guideline applicable to API industry because in whole session I didn't heard any explanation about API industry also PIC guidelines emphasise the applicability of this guideline for different dosage forms
YES. This guideline is applicable for API industry also. The PIC/S suggest applicability of GMP requirements for different type of pharmaceutical entities. Not just process validation.
@@hitendrakumarshah3718 Thank you Sir
@@ulhasdesale2363 Welcome Keep Learning !!!
Sir thank you for such a good video.
I have taken 03 batch for PV and assay results is 102%, 101%, 96% then how to evaluate the results? Because thirds batch have lower assay.
You need to evaluate variability as per the FDA guide.
Please explain how to evaluate variability as per the FDA guide
@@Chikuonline I will take a separate session on this topic.
If the batch size is increase, does tha process validation required or not???
Yes. Of course
Sir Could you explain how to select sampling during blending stage?
What exactly you need. Please clarify your question so that, I can guide you correctly
Sir, good training session. If you discuss problem observed during validation batches like oos, any event during manufacturing etc.the what it's impact on that validation batch
Plz discuss.
I understand your requirement. As, you are well aware that, I am arranging FREE learning for all. This topic is very big and require at least 2 full days to discuss completely. I am considering all points during my full two days seminar - like practical problems with examples during validation, statistical evaluation by different methods, reduced validation testing scenario, compliance approach to continued process verification, discussion on examples of FDA citations and many more. These all points not possible in just 1-2 hours.
Non critical process parameters are mentioned is EU guidelines but sir where it is mentioned in EU guidelines
Annex 15 "Process validation should establish whether all quality attributes and process
parameters, which are considered important for ensuring the validated state and
acceptable product quality, can be consistently met by the process. The basis by
which process parameters and quality attributes were identified as being critical
or non-critical should be clearly documented, taking into account the results of
any risk assessment activities."
How many maximum sampling points taken for validation batch. Purpose
You need to evaluate based on equipment, product and process.
which specification is more tighter In process or finished product?thank you
It depends on the process which is being followed. However, as a generic case, we can have stringent limit at inprocess stage. While finished product limit can be relaxed one.
I thank you sir. Can you direct me which guidelines point this fact beyond our general thought.
Dear sir, Please take a presentation on vendor management.
Sure. I will take Live Training on Vendor Management
Hope you attended the training
Yes sir, I have attended nice training sir. Audit qualification webiner details pls
Please any one answer me why periodic validation while doing continued process verification
During periodic validation, you are evaluating all the aspects including equipment also. So, it is required.
Please post about autoclave validation
Yes. I need to prepare it. Definitely I will prepre video on it.
Dear Sir
What is mean by stratified sampling please explain?
stratified sampling is performed during the process validation. There was separte FDA guideline for this aspect. This guideline is withdrawn by FDA but still it is in practice and followed.
@@hitendrakumarshah3718 Thank you Sir
@@ulhasdesale2363 Welcome. Keep learning !!!
Sir drying is critical process parameters
It depends on the process. In most cases Yes
Hi
I want to take continuous guidance from you. How ?
Be in touch with me. Subscribe youtube channel and request to share the link to your colleagues for subscribing youtube channel. Thanks
Amazing sir
@@AnkurSharma-ob8od Thank you. Keep Learning !!!
What is concurrent release,
I suggest to go through the video in detail. It is explained. If you have further any questions, please feel free to ask in comment section.
Why periodic validation of process
To evaluate the variability and ensure no impact of variability
Who is responsible for preparation of process validation protocol? Why?
It depends on organisation. It can be prepared by QA or even developement QA or R&D.
@@hitendrakumarshah3718
Thank you for guidance...
@@veenapandit3921 Welcome !!!
Hi
Hello !!!
Yes
Thank you so much for your kind confimation
How many lots of APi used for zEu and fda
How many lots of API to be used for exhibitb process val
Yes
Thank you for your kind confimation
Yes
Thanks
Yes
Thank you so much for your comment !!!