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Any one know about FDA's GMP, 21 CFR Part 111

Scott Catron

Scott Catron

True Artisan
Super Moderator
#11
#11
Re: Any one know about FDA's CMP 111

pettie said:
The managers here, and there are many like them in this field don't quite understand the remifications of not adhearing to the rules.
Click to expand...
One visit from the FDA and they'll get the picture pretty quick.

The regs are odd - section headers are questions:

Subpart E--Requirement to Establish a Production and Process Control System
§ 111.55 - What are the requirements to implement a production and process control system?
§ 111.60 - What are the design requirements for the production and process control system?
§ 111.65 - What are the requirements for quality control operations?
§ 111.70 - What specifications must you establish?
§ 111.73 - What is your responsibility for determining whether established specifications are met?
§ 111.75 - What must you do to determine whether specifications are met?
§ 111.77 - What must you do if established specifications are not met?
§ 111.80 - What representative samples must you collect?
§ 111.83 - What are the requirements for reserve samples?
§ 111.87 - Who conducts a material review and makes a disposition decision?
§ 111.90 - What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with 111.70 is not met?
§ 111.95 - Under this subpart E, what records must you make and keep?
 
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B

bubonic

#12
#12
Re: Any one know about FDA's GMP 111

My understanding is it's about security. Password entry for stages etc. I only know that our quality management software system (Q-Pulse) is compliant in advance of this threat!
 
B

Blue KJ

#13
#13
Re: Any one know about FDA's GMP 111

bubonic said:
My understanding is it's about security. Password entry for stages etc. I only know that our quality management software system (Q-Pulse) is compliant in advance of this threat!
Click to expand...
The security with passwords and electronic signatures is 21CFR, part 11 not part 111.

21CFR part 111 is the new section for Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Technical. It is the dietary supplements version of 21cfr, part 211 for drugs.

-Brian Davis, ASQ CQA/CQE
 
M

macfbiker

#14
#14
Try looking for the NSF GMP Guidance Document for 21CFR111 from the NSF website. Nice comprehensive look at the GMP requirements for supplements.
 
C

Caster

An Early Cover
Trusted Information Resource
#15
#15
Re: Any one know about FDA's CMP 111

pettie said:
They are registered with the FDA, but in the past there were no guidlines for dietary supp. manufactors so they didn't have any rules per'say to follow and now the FDA passed the 21 CFR part 111. giving accountability to this group. The managers here, and there are many like them in this field don't quite understand the remifications of not adhearing to the rules. They've never had rules to follow with the FDA.
Click to expand...
Time for a good frank discussion with the managers.

Forget the rules at first, how do they feel about their supplement? Is it good, is it the best, is it safe, do they take it themselves, would they feed it to their kids?

How do they keep the stuff free from contamination, how would they feel if a supplier substituted a raw material without them knowing (infamous melamine in formula). What if a disgruntled employee put some poison in it (Tylenol).

More basic questions, do you speed on the highway, what if you get a ticket, is it your fault or the government stifling your free will? Do the ends justify the means? Is profit the only thing that matters.

If they are good actors they can look at the regs as free consulting, a chance to put systems in place to prevent the most common problems that have happened to others in the past.

If they don't understand the ramifications in food I'm concerned about their ability. People could die from their supplement - and they need to be dealing with that, not complaining about regulations.

Wow - sorry about the rant, but Ilike to think the food I eat and the pills I take are safe.
 
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