I want some information regarding continued process verification so please provide us draft copy of continued process verification as per FDA guideline
Your kidding! Each protocol is unique because each manufacturing process is unique (therefore a draft copy would be useless).
you are aware for continued process verification how many batches will be taken for the preparation of CPV
Once the process validation batches are made and the final study report signed the manufacturing process is continuously monitored (irrespective of the number of lots). This can be by online UV, NIR, FTIR… They are looking for blend uniformity, API assay…
Sir I want only information that FDA guideline said that the all process critical parameter and quality parameter to be enclosed this CPV protocol,
The CPP (critical process parameters) vary with manufacturing process. Usually these are items like time, temperature, concentrations, pressure, speed… Your CQA (critical quality attributes) are usually your specifications for the drug product. In essence by matching the CPP with the CQA you are demonstrating that your manufacturing process can make the drug product (this is the essence of PV).
Sir FDA guideline said that process design and second process
qualification ( PPQ) so let us know how many batches will be taken for PPQ
validation and after completion of PPQ we will yearly prepared the
continued prices verification
Or monthly preparation
There is NO guideline, but you need at least 3 lots for a statistical analysis (%RSD). Typically for PPQ, I take a commercial lot and subdivide it for robustness testing (speed and compression testing for tablets).
Use a matrix to select the appropriate CPP’s for your ‘critical process equipment’ like the centrifuge, granulator, tablet press…
Sir what difference between matrix and bracketing please explain it and
when used for matrix and bracketing
They can be the same or different. For instance you can bracket each end of the assay specification range (98.0 - 102.0%) but in your matrix you would have 1.0% increments in the specification thus, (like 98.0%, 99.0, 100.0, 101.0, 102.0%)
Sir I want some information regarding the qualification of compression
machine which parameter to be evaluated
I asked regarding the process validation when we will be used matrix and
Formulation composition, speed (rpm), pressure.
Use your drug specification (CQAs) to bracket and and a matrix inside. Use your CPPs (above) for each piece of critical equipment to prove you can make the drug product within specification. Read ‘tablet and capsules’ magazine!
As a ‘Quality Engineer’ you should know the operating parameters (Cpps) of each piece of critical equipment! If not, go out and ask the operators.
Sir please let us know which parameter evaluate during qualification of
compression machine and which guideline used for qualification of
There really is NO guideline(s)! They are ‘thou shalt’ documents which tell you don’t do anything stupid and don’t screw up! They are;
- FDA’s process validation guidance of 2011.
- Health Canada’s guideline number #29
- EMA’s (Eudralex!) process validation guidance.
The real question is whether you can make the drug product within the specification!
You can probably use this!