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Computerized Systems Used In Clinical Investigations 2007
Electronic Records; Electronic Signatures (21 CFR Part 11) Human Subject Protection (Informed Consent) (21 CFR Part 50) Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products (Interim Rule) (21 CFR Part 50, subpart D) Financial Disclosure by Clinical Investigators (21 CFR Part 54) Institutional Review Boards (21 CFR Part 56) Forms 1571 (Investigational New Drug Application) and 1572 (Statement of Investigator) Investigational Device Exemptions (21 CFR Part 812) Premarket Approval of Medical Devices (21 CFR Part 814
Quality Systems Regulations (21 CFR Part 820)
Addendum to the Instructions for Completing FDA form 3500A with Coding Manual (MEDWATCH)(MDR)
Guidance for Industry: Medical Device Reporting - Alternative Summary Reporting (ASR) Program
Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use
Instructions for Completing Form 3417: Medical Device Reporting Baseline Report [MDR]
MDR Guidance Document No. 1 - IOL - E1996004
Medical Device Reporting - Remedial Action Exemption; Guidance for Industry and FDA
Medical Device Reporting for User Facilities
Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers
Variance from Manufacturer Report Number Format
Post: Process Validation (Topic#1926)
Anonymous 05-27-05 02:00 PM - Post#1926 I'm looking for online reading materials for Process Validation as per required by the FDA's QSR. And, any good suggestion how to start a process validation for latex condom dipping process. Beside dipping process, any other processes need to be validated?S. Lee [wisefact@yahoo.com] PaulS Member
10-18-07 02:28 PM - Post#4237 In response to Any Process Validation (PV) would be proceded by the system / equipment having been qualified.
i.e. DQ (URS, FRS DEgin) / IQ / OQ / PQ.
When the system / equipment has been qualified then you know it is suitable for its intended purpose and it has met the requirements of the end users, by testing the outer ranges of the requirements etc.
Now to validate an individual process for an individual product you must start with the specification for that product. This will be handed down from the product developers and the QA dept. Trials may be need to be done to establish the system / equipment settings to achieve the specification. NOTE these trials are neither qualifications or validations. If you know the out come it is a validation if you do not know the out come it is a trial, never get the two mixed up. To ensure that the product is being made within specification you must now produce the product and start your Process Validations (PV).
This has to be done using an agreed PV protocol. You can use AQL sampling plans or process capability indices (Cpk). You execute your PV protocol taking samples and measuring what ever the parameter is(whilst logging the sys /equip settings). Once you have passed the agreed acceptance criteria of eithet AQL or Cpk then the process has been validated. Ongoing monitoring should be done and change control set up around the sys /equipment settings.
PaulS Irena Beginner
01-11-08 03:36 AM - Post#4408 In response to PaulS
How can ı do risk assessment for the process validation of granulation step? If there are moisture or pressure or heat at the any process step, this step is under the risk, aren't there? Regards
Irena JohanJ Member
01-11-08 04:41 AM - Post#4410 In response to Irena
Risk assessment can be done through HACCP (Hazard Analysis on Critical Control Points).
You decompose your process in all its different steps plus all interventions/changes made to the product by men or machine in each step.
Then you evaluate each parameter of each manipulation in every step to its impact to product and environment.
Don't forget to consider the immediate environment as this has often impact; and don't forget to also evaluate the process taking the viewpoint of (cross)contamination risks.
Normally you do process validation when the process is already defined by R&D. So in fact it is at the process developping stage that this analysis should occur so that engineering/production can take this into account when purchasing or modifying machinery. (e.g. installing machinery for production of a very hugroscopic product in an environment where you do not control humidity levels = bad engineering)
The risk assessment you do for PV is saying which parameters are critical, but as mentioned above R&D should have these already by the time you qualify production equipment and the full production process.
Is this what you talk about or is it a different aspect of assessment, validation you meant? Johan Janssens
Irena Beginner
01-11-08 07:09 PM - Post#4412 In response to JohanJ
I mean, if the any process step is affected to product quality, this step is risky. QA and R&D department are assessed together to risks for the production. Best regards
Hande JohanJ Member
01-13-08 08:37 PM - Post#4417 In response to Irena
R&D and QA together should have charted all process cirtical steps and parameters.
Without these informations you would not be able to know how to control your production process and certify a good yield. Johan Janssens
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