Mixing of two different lots lubricated blends (tablets)

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

Hi Forum

I am making one tablet formulation where the lubricated blend of product is same for two strengths. I want to meet the market requirement of one strength; in this case I have two questions

  1. Can I mix another lot blend (meeting with specification) with existing blend and proceed for compression.
  2. Shall I compress one after the other blend and combine the tablet formulation in one lot?

Regards

2

I think you should make two lot no on paper (all documents) if the composition are same for the product.

3

[quote=gireesht01]Hi Forum

I am making one tablet formulation where the lubricated blend of product is same for two strengths. I want to meet the market requirement of one strength; in this case I have two questions

  1. Can I mix another lot blend (meeting with specification) with existing blend and proceed for compression.
  2. Shall I compress one after the other blend and combine the tablet formulation in one lot?

Regards[/quote]

Hi first thing if these to lots are for different market then they are seperately manufactured. or u should make common blend for both, but same u have process validation for scale up, also u should compressed for same at single time and packed as per market requirment. but doccumentation will be same up to manufacturing process.

4

[b]If you are making this formulation at R&D you must take those two blends seperately and make each as per sequential procedure. There is a reason for this.

  1. If a problem occurs in the total blend this would impact the other strength of formulation too.

  2. May be based on the strength of other formulation and its hygroscopicity , bulk density and flow properties a little adjustment might be needed in production. (Who knows what and how it behaves in production levels of manufacturing?).

3.Its good to make each formulation and document at the same time. Mixing the blends is not like making a base for food at hotels. Seperation is always necessary.

4.The evolution of basic BMR takes at the R&D stage. Each product and each strength of product must have a BMR and based on the developmental study, prepilot and pilot batches the Inprocess controls/Checks and limits will be made. Any flaw or overlap of processes at this stage would result in a poor BMR and also a batch that is not properly controlled.

5.You must follow a strict sequence of design of experiments and also Quality by Design at the basic R&D stage which will be evaluated during the product life cycle management.

Never hurry & Never overlap experiments and never jump inprocess steps.[/b]Every blend behaves seperate and every strength is a new product.

This is how companies became bigger and bigger over period of time.

Regards

5

Dear Sir,

you r absolutely right…
this sentance inspire most…“This is how companies became bigger and bigger over period of time.”

thats way u r guru

hattsoff sir
huma ali