Houston, TX: Workshop II
Key Issue:
What mechanism should FDA use to ensure the proficiency, integrity and credibility
of private sector sampling and analysis of regulated products?
- Participate is ISO/international accreditation.
- FDA/state should be able to certify/audit enter the certification system.
- FDA/state should be able to certify/audit enter the certification system.
- Coordination of Federal agencies to what is necessary to certify
- Accreditation does not assure validation
- ISO25 will serve private laboratories
- Sample collection - random audit sampling/collection reports
- Detention of what constitutes a lot case by case
- ISO25/credibility in-house audits/QA's
- Not all private laboratories have in-house audits/QA's
- Not all private laboratories have in-house audits/QA's
- Hypertext link to making methods available
- How do private laboratories make ISO25 work for all private laboratories?
- Methods - expectations of methods - who determines method
- Will private laboratories participate documentation
- Performance expectations
- Do we do it (FDA)
- Who audits
- Who tells 3rd party what criteria is - FDA?
- Who tells 3rd party what criteria is - FDA?
- Who tells 3rd party what criteria is - FDA?
- A working internal mechanism - system and analyst
- Who should do internal audit?
- 3rd party
- Who pays - the private laboratories - is it cost effective?
- Will it guarantee more business for private laboratories
- Without regulatory agency doing audits - where is consumer level confidence. Does not
see state as regulatory agency because of state to state variables
- Sometimes private industry uses its own to police themselves i.e. A2LA
- Specific training for
- What if accreditation does not generate extra income
- FDA should be able to say - work accepted by accredited facility
- Two tier system for audits
- Small labs - regulatory agency audits
- Large labs - 3rd party
- Not a level playing field - expensive for large labs, small labs say Level playing - let
small labs grow
- Large labs competing with small labs for same type work
- QA program - let private labs find out what is out there within their own peers and
competitors
- ISO25 proficiency testing - overnight
- (1) expenses
- (2) methodology
- (3) certified references
- 1. Are these long term expectations?
- 2. What is current reality - will all private laboratories participate?
- The time is now for ISO25 because
- (1) customer wants to know
- (2) protection-liability
- (3) global consistency
- (4) standards - references
- Accredited sample program - AOAC/FDA
- Some accreditation does not generate good results
- QA's: check sample series - own private laboratories might initiate
- QA program plus proficiency testing plus ISO25 = mechanism to insure confidence
(downfall - cost) might get right answers one time but not representative of capability
- You are willing to compete and show yourself competent
- (1) appearance of "heavy-handed"
- 2) is there a need to show all analytical work
- QA - bottom line - who is going to do it
- (1) 3rd party - cost will FDA recognize
- (2) FDA audits - resources, how often, for what analyses
- Consequences
- Standardization of all labs
- Standardization of methodology who s
- What makes it equitable - i.e. HACCAP plan for different areas
- Lab sizes - develop generic plan - a panel of components
- Minimal requirements generic plan - for QA
- A checklist for anyone to audit
- A regulation to require or else no incentive to participate
- Submit QA plan and analytical package
- Incentive - client satisfaction
- The generic plan - will include QA types of things
- Sampling - FDA should certify sampler
- Homogeneous sampling
- Analytical results - private laboratories find a reason why
- Minimum requirement should not have less than ISO25 (5 dots)
- ISO25 Competency standard monthly includes proficiency
- Training GMP ongoing
- QA joint agreement - FDA plus 3rd party
- QA used as marketing tool
- FDA training to private laboratories benefit to consumer
- Private laboratories shopping by importer based on violative findings unfavorable
- Inconsistency by FDA
- Audits as help, not threat includes training
- (1) accreditation organization independent of FDA (with FDA approval) for analysis. FDA
oversight i.e. ISO25 Funding? i.e. fees paid by private labs - importers
- (2) assessment of private laboratories check sample site/sight visits vs GMP regs/GLP
inspection,s annual reviews
- (3) FDA initiated guidance - flexible SOP, internet, FDA - to train private laboratories
re: sampling
- (4) private laboratories liable for its results
- (5) private laboratories with FDA guidelines stands by results
- (6) private laboratories
- a. demonstrates GMP audit, GLP (reviewed annually)
- b. check sample
- What are inspectors loading for - once a GMP always a GMP?
- Check sample to follow
- ISO25/EMC
- Result reporting/Trust FDA/private laboratories
- Violative - importer vs private laboratories
- How many times sampled Training by FDA
- 3rd party sampling
- Importer pick testing lab
- Time frames
- Report all results for multiple sampling
- Importer/broker notify FDA:ID testing lab
- Report to FDA first (FDA general counsel)
- FDA initiated
- Model lab services agreement include FD&C;
- Lab reporting
- Consistency among districts
- Recognition of private laboratories nationally
- FDA-broker importer-private laboratories
- Private laboratories national data base broad based
- Ensure integrity and credibility
- a. private laboratories accreditation
- b. 3rd party (FDA oversight), e.g. ISO25 (2 dots)
- Competency and proficiency
- a. annual reviews
- b. check samples
- c. GMP inspection
- d. training
- 1. sampling
- 2. technical training eg organoleptic
- 3. SOPS - internet
- 4. FDA guidance to GMP's/GLP's (what is FDA looking for)
- Private laboratories liable for its results
- Private laboratories stands by its results
- Inconsistencies in FDA from district to district
- Model lab services agreement
- Flexible regulatory approach
- Attitude problem (audits as help not threat)
- Sampling
- a. 3rd party
- b. private laboratories
- Reporting of analytical results
- a. importer/broker identify private laboratories upfront
- b. time frames
- c. report all results (2 dots)
- Private laboratories national database broad based
- Private laboratories/FDA partnership
- Efficiency