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Associate

Join Date: Nov 2007
Location: Beirut
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Validation of Pharmaceutical Building Management System

07/24/2010 5:29 PM

Hi all. I'm being asked to supply and install an BMS system for a pharmaceutical facility. I'm told the facility will be validated . I'm aware that my system should comply with GMP & 21CFR Part 11. As I dig further on the subject I realize 21CFR Part 11 concentrates mostly on the security issues of logged data. My question is could someone tell me what is meant by validation and how will my system be validated (I mean this validation issue is totally new to me). My second question is should my hardware be of a special grade? for example Hospital grade? Or do Pharmaceutical grade equipment exist?. If yes How can i show my client that this product is of a grade that complies with GMP? More simply put, what are the requirements of my hardware and software or any other related things to be compliant with GMP and 21CFR Part 11 and get validated. Would much appreciate if someone could enlighten me. One final word , I would like to add that this project is not in the USA nor in Europe, but it must match those standards

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Guru

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#1

Re: Validation of Pharmaceutical Building Management System

07/24/2010 10:46 PM

Can you Google? I won't do it for you.

Validation of Pharmaceutical Building Management System

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#2

Re: Validation of Pharmaceutical Building Management System

07/25/2010 11:22 PM

Validation is nothinn but verifyind that the system is performing as per the expectations of the Standards, it is more of documentation in the sense, you will have to document everything. From Installation, calibration and operation of the BMS. If you are aware of what class your rooms are? based on that the minimum no of airchanges should be met. These requirement are generally given by the user. As you said 21 CFR part 11 is more into the security, the software should be able to provide report in a tamper proof format (PDF with digital signatures etc). These ar mainly for audit purposes. GAMP5 is a good document to refer for understanding Validation. See if you can get hands on one. Go for a BMS system with any prominent vendor any specify that it has to be compliant to 21 CFR part 11. the hardware if placed in the clean rooms ( the conditioned space) it should be SS316L also you can specify GMP grade to vendors., if it is going above false roof you can go for normal devices.

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Power-User

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Location: Europe
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#3

Re: Validation of Pharmaceutical Building Management System

07/26/2010 6:41 AM

MOURADIG,

Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled - this is the definition from CFR21 Part 820.3 (Medical devices regulations and not Pharmaceutical)

I would suggest that you will Qualify your equipment rather than Validate it, generally equipment is Qualified and Systems are validated.

The customer has probably issued an URS (User Requirments Specification) for the project (If not then you should either request this or else walk away from the project - otherwise you have no way of knowing what the customer wants and therefore nothing to qualify against) and you have provided a proposal based on this. If you are successful with your proposal then you will most likely provide a FS (Functional Specification), SDS (Software Design Specification) and a HDS (Hardware Design Specification). Then there will be all the risk analysis activities that need to take place and all of the design reviews and the traceability matrix. Once your equipment is built / softwqare written then the customer will require you to perform a FAT (perhaps not possible in this situation), a SAT, IQ (Installation Qualification, OQ (Operational Qualification), PQ (Performance Qualification) and provide all the associated IQ/OQ and PQ reports along with the raw data- it is unlikely that you will carry out a PV (Process Validation) and that is why I stated earlier that equipment is Qualified and Systems are validated. I would suggest that you contact the company that you are going to provide this equipment for and see what their intention is - it varies widely from company to company.

Re 21CFR part 11 Electronic Batch Records and Signatures: This has two components- 1. The electronic batch records and 2 the electronic signatures. The FDA has recently withdrawn its guidance document on this subject and have indicated that they will not be re-issuing this. Alot of companies request that the systems are 21CFR part 11 compliant without actually knowing what is involved - only electronic records and associated signatures that are required to be maintained under predicte rules are subject to 21CFR part 11. Electronic records and signatures that are not required to be retained under predicate rules are not subject to 21CFR part 11. Then of course there is the whole question of whether this is a closed system or an open system and whether this is is a Hybrid system etc.

Re special equipment: This depends on what exactly you are going to supply. If it is just the Air handling system and the control system then there my not be too much to it (just keep a eye out on the equipment/instruments/ HEPA filters etc that will be in the actual room). An easy method to test/ calibrate/ maintain the equipment/ instruments would be something that I personally would be looking out for in the design of the system. However, more details on what you are providing would be useful in trying to determine what is required.

I would suggest that you visit www.fda.org and read more on this subject and Qualification in general. The ISPE is also another good resource for information and training courses (www.ispe.org).

There are good reasons for all of these requirements issued by the FDA and other regulatory agencies that those who do not work in the industry (Pharma and Medical Devics) have a difficult time in understanding.

You will probably find that the actual paperwork side of things outweighs the actual physical engineering activities. Finally remember that if it is not documented then it is not done - it is that simple.

Kind Regards

Mr. W.A Snow

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Member

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#4

Re: Validation of Pharmaceutical Building Management System

07/26/2010 11:38 AM

Hello MOURADIG,

The one engineer that can answer any and all of your questions is Mike Monico.

The last I knew he was working out east at Schien Pharmaceutical.

Mike is the best.

Kenneth D. Allen.

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