Hello to everyone,:D

I am a new member, and I have realized your forum is very professional and state of the art regarding quality issues. I am very please to have the opportunity to read information about QSR and ISO standard for Medical Devices.

Currently I am a student from Mexico and after graduating my objective is to get a job in a pharmaceutical industry, my thesis idea is to build a quality system for a hypothetical pharmaceutical industry, where main product is physiological serum and market at USA.

My questions are

Does GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers: 3 Volume Set by Leonard Steinborn, ISBN 9780849318498 cover everything needed for a complete Quality System?

If this manual is not enough What else is necessary for fulfilling my quality system documentation?

I will appreciate any comment you have

Regards
:thanx:

Include IQ, OQ, PQ along with validation and qualification procedures. Incorporate 21 CFR 820 and GMP & combine it with a quality system that is based on the ISO family - 13485, that should suffice - although, you have somewhat of a big job ahead of you if you have to set up the whole system.
The way that you set it up also depends on the structure of the company you are running - are you going to be the OEM, the vendor / manufcturer in the creation process, or the distributor in the food chain? This will impact how your procedures are going to be written and the actions that need to be described within your quality system.
Hope that helps instead of confuses.

Thanks for your prompt answer.

I will be the manufacturer, does this imply the use of other QSR and ISO standards, please guide me which additional ones from the manual scope.

Regards and :thanx:

Hello to everyone,:D

I am a new member, and I have realized your forum is very professional and state of the art regarding quality issues. I am very please to have the opportunity to read information about QSR and ISO standard for Medical Devices.

Currently I am a student from Mexico and after graduating my objective is to get a job in a pharmaceutical industry, my thesis idea is to build a quality system for a hypothetical pharmaceutical industry, where main product is physiological serum and market at USA.

My questions are

Does GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers: 3 Volume Set by Leonard Steinborn, ISBN 9780849318498 cover everything needed for a complete Quality System?

If this manual is not enough What else is necessary for fulfilling my quality system documentation?

I will appreciate any comment you have

Regards
:thanx:

Hi KARELYSAL,

Welcome to the Cove and thanks that you found us.

Regarding your question, I have not seen the book but remember that when you want to write a quality system manual, ensure that you address all requirements of ISO 13485 and US FDA requirements (as you will be marketing in US). You could visit www.fda.gov and do a search function to get all applicable guidelines.

I assure you that you will the FDA website very resourceful :)

If you have any further specific questions, we will be pleased to address those.

Best Luck :agree1:

Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant.

I want to comment about pharmaceutical and medical device philosophies in general, using the FDA regulations as an example. (I do not want to cover ISO/AAMI/ANSI now, because there is a philosophical difference between FDA and these other bodies, not necessary the regulations/specifications.)

One of the most common concerns is having the proper personnel involved in pharmaceutical and/or medical device operations (be them FDA investigators, Notified Body staff, academics, consultants, or industry staff).

If FDA, Notified Body, consultant, academic, and/or industry personnel are versed in pharmaceutical operations and applicable regulations solely, quality problems will occur if these schemes are brought to the medical device area. This is because the FDA quality regulation for medical devices (21 CFR 820- Quality System Regulation) as compared to its pharmaceutical counterpart (21 CFR 211- Current Good Manufacturing Practices for Finished Pharmaceuticals) differs in philosophy and scope. (Even note the title differences in these regulations.)

Basically, certain operations (such as change control, process validation, and acceptance testing) are "black or white" in the pharmaceutical area (no matter which manufacturing site or process is involved), where similar operations can be "gray" in the medical device area (even from product to product or process to process at one site).

For example, in the pharmaceutical area, one has to validate a quality or manufacturing process (traditionally via a IQ/OQ/PQ prospective validation scheme)- be it a new process or changed process. However, in the medical device area, one has to first determine whether the new or changed process can be fully verified by subsequent inspection and test. (This is a highly confusing concept for a pharmaceutical person now involved with medical devices.) The key word is "fully"- because certain tests will cause product destruction or not be cost beneficial. If not, then the process has to be validated (either by prospective validation-IQ/OQ/PQ/PPQ [PPQ is a step not required by the pharmaceutical industry], retrospective validation, or concurrent validation).

Sterilization is a prime example. If one is to fully verify the sterilization operation, every unit will have to undergo sterilization testing. This is great quality-wise because this acceptance testing will show that each unit has passed or failed applicable firm specifications, but the firm will have no products to sell because each unit in each batch (i.e. 100% testing) will have to be opened and tested (thus compromising the sterile barrier).

Another area is acceptance testing. Pharmaceutical companies have to follow applicable test schemes (such as contained in the US Pharmacopia) (unless they can validate to change the method, but the test requirements have to be followed- such as needing to have "X" amount of active ingredient). However, there are no test schemes in the medical device area. Companies can conduct whatever type of tests they choose from their own specifications (usually developed after they conduct design control operations, depending upon the product classification).

I hope this helps. :)