Coming from GMP commercial biotech into a GLP lab area I would like some feedback on where within a GLP facility other than method validation would you need to have validationqualification. For example would these following systems require validation? utilities,HVAC, environmental chambers,freezers, refrigerators, animal facilities)
Validation is required when and where risks say they do.
If the laboratories, or parts of, are used in support of regulatory activity, then validation is required.
HVAC validation is required when temperatures, humidity, and/or balancing may impact the quality of data and/or lab operations, samples and/or processes, directly and/or indirectly.
Environmental and Stability Chambers require validation if the data collected is used in support of filing, and/or used directly or indirectly in support of regulatory decisions.
Utilities validation is also a consideration where the utilities may impact the quality, efficacy, purity, stability and/or validity of laboratory processes, samples, data, and operations.
Equipment used in support of those processes, also requirement validation and/or qualification.
Sincerely, John F. Cuspilich, Sr. Consultant RA/QA
FDA.COM
The Auditing Group, Inc.
GMP Publications, Inc. jcuspilich@auditing.com jcuspilich@fda.com
856-596-2333 - 866-GXPNews
Is there a distinct difference between qualification and validation? If so, what is it?
My perspective is that qualification is the process of validating. Would there ever be a time when it was not necessary to go through the entire validation process in a GLP lab.
Also, I come from a GMP background myself and am finding it very difficult to discuss my perspective of quality standards due to others not agreeing that GLP should have similar standards of quality. Although GLP is not as strict in some aspects as GMP, it is still strict enough to have many controls in place. Any advice on how to handle confrontation and resistance in quality practices? Would a good description of the differences between GMP and GLP suffice. If validation and other systems still need to be in place for GLP, it seems that the only true difference may be that GMP requires more HVAC validation and more sterile standards.
I should note that I work for a very small start up company in a brand new QAU role. This role is brand new to the company, and there needs to be a lot of work done from a quality stand point. Most of this work is not generally understood as being needed by the others I work with and I have been told it is not important at some times. Any advice on how to handle others would be greatly appreciated. This is a very difficult position to be in.
FDA Definition Validation Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
Qualification = Establishing documented evidence which provides a high degree of assurance that a specific system (equipment) will consistently perform according its predetermined specifications (GMP aspect)
So both have the same ROOTS. But you can say that equipment and systems (the physical stuff) are qualified, cause you are going to check whether it is FIT and adequate for use(it is qualified for the job)
Methods and processes (which make use of qualified systems are validated
This seem to clearly be requirements for GLP that is regulated by GMP regulations. What about the GLP regulated by 21 CFR 58. Do those labs need qualification and validation of equipment also?
I like to keep it simple! Qualification generaly infers to testing the equipment and systems to be used. Validation infers testing the processes, which will use the afore mentioned equipment, to create product or support cGMP activities.
Labs need to do risk analysis to determine the level of compliance testing. Generally speaking, If the equipment and processes of the lab support cGMP activities, you should validate accordingly. I work for a company that produces equipment, and provides qualification of our equipment. The problem of under qualifying, always comes up as an after thought, once an audit is conducted. When in doubt, I always suggest a risk analysis.
Risk Analysis
Step A - The equipments use in cGMP activities.
1 - No Impact: Equipment will not be directly or indirectly associated with cGMP activity.
2 - Minimal Impact: Equipment indirectly affects cGMP processes or procedures.
3 - Potential Impact: Equipment performs or directly supports a cGMP process or procedure; failure could have a negative impact on product quality. Equipment failure could negatively impact operational efficiency or costs.
4 - Critical Impact: Equipment is an essential component of a cGMP process or procedure, or is in direct contact with a drug substance or drug product. Equipment failure could result in loss of product; safety hazard; damage to materials, equipment or facility; or negative inspection findings.
Step B - The equipments effect on cGMP activities.
1 - No Impact. No risk control necessary
2 - Minimal Impact. Failure of the equipment would be detected immediately and be corrected before affecting a cGMP process or procedure
3 - Potential Impact. Failure could NOT go undetected. Systems and procedures are in place to detect negative impact on product quality safety or purity before significant loss of productivity.
4 - Critical Impact. Failure could potentially go undetected and cause failure of other processes or procedures.
Step C - Technology Risk
1 - No Impact. Very simple system; minimal chance of failure.
2 - Minimal Impact. Commonly understood technology, rugged equipment; low probability of failure.
3 - Potential Impact. Somewhat complex equipment, generally reliable technology, components and/or controls.
4 - Critical Impact. Highly complex and/or sensitive equipment, sophisticated technology, unique components or processes.
Step D - Technology Risk Management
1 - No Impact. Control and repair possible without impacting cGMP activities.
2 - Minimal Impact. Equipment requires minimal training, simple maintenance procedures; back-up, repair, or like-for-like replacement is readily available.
3 - Potential Impact. Requires trained operators and maintenance technicians. Backup systems, repair, maintenance and replacement are readily available.
4 - Critical Impact. Operators and maintenance technicians must be highly trained. Maintenance, repair or replacement requires specialized and/or time-consuming effort; backup systems, repair, maintenance and/or replacement are not readily available.
You take the sum of Step A and B, and multiply the value to the sum of C and D. The higher the result, the more qualification and Validation is recommended.
I would quote my source for this, but I have had this for a long time, and can't remember where it came from.
dear Sir,
we are preparign valiation protocol for HVAC system (Including software"Web Ctrl"). But i am confused how to prepare and what should be included. Can you give me some suggestion or provide some template?
Are you sure you want to validate the HVAC system?
I do not know what process you are running but as long as the process/products are indifferent to temperature and moisture levels/fluctuation I would not qualify the HVAC but qualify the clean room. You define your clean room up to the small particle filter (HEPA, ULPA). Filters bound to the HVAC you put in a maintenance program to have them regularly checked.
In this way you avoid the qualification of the HVAC controller, which would be very complex and VERY unnecessary to do. Cause almost none of it has an impact on product/process quality. Unless when working with specific products/processes which require specific conditions.
So maybe you need to reconsider the HVAC qualification in your story.
PS if its room qualification you are after be sure you have a set pressure, temperature humidity transmitters installed in your room. Do not rely on those of the HVAC.
I agree with Johan.
Qualification verifies that a unit is suitable for its intended purpose.
Validation verifies that a process is suitable for its intended purpose.
Thus, in qualifying equipment, we execute appropriate steps to validate a process or system.
