Toll Manufacturing or Contract Manufacturing which one should you choose?

by | Jun 11, 2021 | Blog

It is difficult to determine which process is better of the two – Toll Manufacturing or Contract Manufacturing.

It depends upon the source company’s needs and capabilities and if the source company wants to maintain exclusive control and a level of secrecy about the source of raw material or semi-finished product which is going into production. If they do then they should go for Toll Manufacturing. However, the source company should also consider the following:

  • Does the manufacturing company have the capability to handle vendors for the raw materials to be used.
  • Does the manufacturing company have the proper process know-how and GMP certification.
  • Does the manufacturer have adequate manpower to perform the entire product manufacturing activity.
  • Can the manufacturer carry out the activities within the time deadlines?

Depending on their findings  the source company can also go for Contract Manufacturing.

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Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it see… Read more
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