Process Validation Protocol (API) as per new FDA Guidelines

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as per my first reading of new guideline, it has broadened the existing scope by
1)integrating process development + process validation (3-batches...)
2) introducing the life cycle concept of continuous monitoring (concurrent validation)

So, actually speaking, what we must be looking-for is,
First, revise the process validation SOP itself to introduce the above 2-points.
Second, at minute level, define the process capability/variability (to be established in Stage-I, verified at Stage-II, monitored at Stage-III as mentioned in guideline)
Third, Probably create a new SOP for continuous monitoring.

:2cents:

Note : pl. don't get carried away by the terminologies ...but take the essense of it; btw i may be just thinking aloud...And I am taking this liberty because, i haven't heard enough about implementation in the open domain (its probably still a paid seminars, consultant's domain, etc.,)
 
K

kristrainer

While the new Process Validation Guidelines were released in January 2011, they do not give specific information about statistical sampling plans for PPQs. Can anyone advise as to what method to use to sample liquids manufactured in 1000-3000 gallon tanks?
 
T

The Specialist

Can anyody share Process validation protocol (API) as per new FDA guideline?


Is it a PQ example you are after?

Or, do you require a full 'life-cycle' package of documents (URS, VP, DQ ,IQ ,OQ ,PQ, VR)
 
K

kristrainer

Neither. We have been performing process validations for years using the method of sampling from the top, middle and bottom of the tanks and testing for homogeneity ( density, pH, assay). The auditor says we are not collecting enough samples and we must statistically evaluate how many samples to collect. Any ideas?
 
T

The Specialist

Have you determined the 'worst-case' areas of the tank for homogeneity?

i.e. You say you take top middle and bottom samples. Are these taken from the centre of the tank?

In a cylindrical tank of that size, I would be looking at taking samples from the eight ‘corners’ as well as multiple depths through the middle.
 
T

The Specialist

Can anyody share Process validation protocol (API) as per new FDA guideline?


dinu344,

Assuming that you have no need for IQ/OQ/PQ (as it is already done)...

A typical Process Validation Protocol would include the following:

1.Purpose
2. Background
3. Product Description
4. Responsibilities
5. Scope (Tell Exact what you plan to d, i.e. when in the process samples
will be collected and etc)
6. Manufacturing Process Flow Diagram
7. A table for equipment to be used (list your company equipment, equipment
model#, IQ/OQ # and date the IQ/OQ was done)
8.Calibration Record for critical devices (i.e temperature
recorder/controller)
9. Standard Operating Procedures (Overall procedures to manufacture a
batch)
10. Analytical Test Methods
11. Process Parameter(s) to be monitored
12. Sampling plan
13. QC test Requirement (for in-process and finished products)
14. Acceptance Criteria (for in-process and finished products)
15. Validation Report (Tell what final report will consist of)
Appendix: batch document
 
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