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What process and documents are required when handover from research and development to production?


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#1 drk0904

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Posted 11 June 2020 - 06:19 AM

Dear All,

 

 

My company has new products lined up about to be launched in next two years. My questions are

 

1. How does R&D department work in your organization?

2. And what is the handover of process like?

3  What sort of documents does R&D prepares while doing hand over ?

 

I hope I was clear in my questions.

 

Thanks in advance!



#2 pankajchettri

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Posted 11 June 2020 - 10:54 AM

Well it depends, if RND is in house or you have a Bottler model.

What ever be it RND should be through on the process/ lines and machines to start with, where the product is being processed. They should be very clear on the limitations of the machines and all these needs to be factored during the design of the product. 

In most cases the development work happens on the lab, bigger companies may have pilot plants where second level of validation and verification can be done.

 

In terms of documentation there will generally be documents like:

1. PFS - Product Formulation Sheet

2. GTP - Guide to Production 

 

What ever may be the name and format of the documentation, these documentation should clearly layout the formulation, suppliers to be used, specifications of the raw materials, production parameters, physio chemical and microbiological parameters, self life data, risk assessment, trouble shooting......

 

This documents are provided to the production/manufacturing well in advance for review and alignment. There may need to several rounds of meeting for alignment.

Validation and verification becomes the key... on product commercialization. No matter what we know of the product via lab and pilot plant development and trials, actual trials in the line is very important - cant stress more... You may see so many surprises when you are doing the product validation on the lines. I have seen in many cases the timelines significantly changes due to the challenges observed in the first product validation.....

 

Line validations are generally smaller quantities and may not be intended for sale... based on the outcome of the line validation the first commercial production can be planned. If the trial validation was smooth then the handover can happen there, however is things are more complex then RnD support is needed since the first commercial production and may be after that too...

 

If all the boxes are ticked and the product is as per the expectation a final sign off document can be used where all parties like  manufacturing/ RnD/ Marketing/ Engineering .... can sign off...

 

For bigger multinationals and more organised sector they may follow the process of STAGE GATE.....

However that is a separate topic for another day!!!

 

Regards,

Pankaj 



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#3 drk0904

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Posted 12 June 2020 - 05:02 AM

Thanks for clearing my query!



#4 Xenna

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Posted 21 December 2020 - 04:31 PM

.....

Validação e verificação tornam-se uma chave ... na comercialização do produto. Não importa o que saibamos do produto por meio de testes e desenvolvimento de laboratório e planta piloto, os testes reais na linha são muito importantes - não dá para estressar mais ... Você pode ver muitas surpresas ao fazer a validação do produto nas linhas. Eu tenho visto em muitos casos os prazos mudem devido aos desafios observados na primeira validação do produto ...

 

As validações de linha geralmente são quantidades menores e não podem ser destituídas à venda. .. com base no resultado da validação da linha, a primeira produção comercial pode ser planejada. Se a validação do teste foi tranquila, a transferência pode acontecer lá, no entanto, se as coisas são mais complexas, o suporte RnD é necessário desde a primeira produção comercial e pode ser depois disso também ...

 

......

 

O que pode ser feito com este produto desenvolvido durante a validação da linha?

Deve permanecer segregado e ser usado como um reprocesso nas próximas produções?


Edited by Xenna, 21 December 2020 - 04:33 PM.





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