Re: General Controls - GMP interpretation? General Requirements Concering Records
Hello,
Thanks to all of you for your responses...but if it is ok for you...let us clarfy last details regarding that topic...hope this is ok for you.
The QSR states:
Sec. 820.180 General requirements. All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up. [...]
I have marked the first words in the first sentence in red and bold.
When you interpret these words..."this part" means occording to my understanding the part 820...so this sentence is talking about all records required in part 820...???
How do you interpret the first sentence in 21 CFR part 820.180...what does it mean to you, if you were only a class 1 medical device manufacturer??? What kinds of records do you need?
Thank you very much to all your guesses...
Best regards,
Aphel
Hello,
Thanks to all of you for your responses...but if it is ok for you...let us clarfy last details regarding that topic...hope this is ok for you.
The QSR states:
Sec. 820.180 General requirements. All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up. [...]
I have marked the first words in the first sentence in red and bold.
When you interpret these words..."this part" means occording to my understanding the part 820...so this sentence is talking about all records required in part 820...???
How do you interpret the first sentence in 21 CFR part 820.180...what does it mean to you, if you were only a class 1 medical device manufacturer??? What kinds of records do you need?
Thank you very much to all your guesses...
Best regards,
Aphel