How do I prove I don't receive a controlled product? Ractopamine Hydrochloride

M

Mauri

#1
We manufacture livestock feed and some of that livestock ends up being shipped to the EU after slaughter. The EU has banned a drug that is approved for use in Canada (Ractopamine Hydrochloride). We are trying to get Type I (Ractopamine Hydrochloride free) approval and one question that was raised was, how do I prove or guarantee that we don't receive that drug into our warehouse.
We have a few customers that use that drug and we get it manufactured by a third party, but our purchasing department still buys it for use by the third party facility.
So, my question is, aside from employee training on product recognition and procedures of not being allowed to transport that drug on company vehicles (done), and warehouse receiving forms which are reviewed and verified, how do I prove that we don't receive that drug?
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
We manufacture livestock feed and some of that livestock ends up being shipped to the EU after slaughter. The EU has banned a drug that is approved for use in Canada (Ractopamine Hydrochloride). We are trying to get Type I (Ractopamine Hydrochloride free) approval and one question that was raised was, how do I prove or guarantee that we don't receive that drug into our warehouse.
We have a few customers that use that drug and we get it manufactured by a third party, but our purchasing department still buys it for use by the third party facility.
So, my question is, aside from employee training on product recognition and procedures of not being allowed to transport that drug on company vehicles (done), and warehouse receiving forms which are reviewed and verified, how do I prove that we don't receive that drug?
Can someone help Mauri?

Thank you very much.

Stijloor.
 
A

arios

#3
I am not totally familiar with the sector, but I am hoping that a possible suggestion can be considered.

My suggestion is to have an evaluation testing report by a lab. (if the test is available) on your current product. I don't think it has to be done on a lot by lot basis, but rather on single sample to demonstrate that a regular product is free from the subject item of concern. The analysis report could support your rationale that explains how you keep a physical segregation which is effective based on the lab result
 
T

True Position

#4
We manufacture livestock feed and some of that livestock ends up being shipped to the EU after slaughter. The EU has banned a drug that is approved for use in Canada (Ractopamine Hydrochloride). We are trying to get Type I (Ractopamine Hydrochloride free) approval and one question that was raised was, how do I prove or guarantee that we don't receive that drug into our warehouse.
We have a few customers that use that drug and we get it manufactured by a third party, but our purchasing department still buys it for use by the third party facility.
So, my question is, aside from employee training on product recognition and procedures of not being allowed to transport that drug on company vehicles (done), and warehouse receiving forms which are reviewed and verified, how do I prove that we don't receive that drug?
I may not understand the problem completely, if you are only drop shipping this chemical(in a controlled procedure somewhere?) can you just show your auditor a sample customer order and the shipping receipt from chemical vendor to your customer?
 

harry

Super Moderator
#5
....................... So, my question is, aside from employee training on product recognition and procedures of not being allowed to transport that drug on company vehicles (done), and warehouse receiving forms which are reviewed and verified, how do I prove that we don't receive that drug?
Since you are dealing with a legal requirement, you may want to include a Wikipedia reference-linkstatutory declaration (an affirmation that such a drug never enter your premises in the first place - it could be named differently in your country) to complete this whole exercise.
 
Thread starter Similar threads Forum Replies Date
qualprod How to prove improvements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Q Do we have to prove a link between the mill and our raw material supplier? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
P How to Scientifically Prove the Importance of a Process - CMMI Process Areas Software Quality Assurance 7
B How to prove that an organization implements anti bribery policy IATF 16949 - Automotive Quality Systems Standard 8
C UDI Label Verification - How do we ensure the barcode is correct and prove it? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S How to Statistically Prove 2 Dimensions are Related Using Minitab Software 18
U Sample size to prove parts are good with 99.73% confidence Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
L What needs to be done to prove compliance with RoHS and WEEE EU Medical Device Regulations 5
A Is MSA useful to prove a Measurement System after Relocation? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
P How to prove that Cr oxide makes a stent biocompatible (e-polished 316LVM) Manufacturing and Related Processes 9
P Testing a US device in Europe to prove Equivalence in a ?head-to-head? Study EU Medical Device Regulations 6
J Reliability Prove-out, Pass-Fail Testing Reliability Analysis - Predictions, Testing and Standards 2
K What would you give up to prove conformity and honesty? Internal Auditing 21
S ISO 17025 requirements not enough to prove NIST Traceability? ISO 17025 related Discussions 10
I Prove or disprove that a cube can be cut in 27 smaller cubes in less than 6 cuts Brain Teasers and Puzzles 14
C Clinical Data to Prove Equivalence Other US Medical Device Regulations 4
U Can anyone prove that: 2x2=5 ? Coffee Break and Water Cooler Discussions 63
D Testing an Inspector to Prove Competency in Visual Inspection Records and Data - Quality, Legal and Other Evidence 2
S Lean System Developer - How should I work to prove myself? Lean in Manufacturing and Service Industries 19
D How to Prove and Explain to Consultant (Internal Auditor) and Manager? Internal Auditing 7
M Planning requirement 5.4: How should the management prove compliance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J How to prove that we conform to legal requirements Miscellaneous Environmental Standards and EMS Related Discussions 11
L Is there any way to prove a process is in control other than with a control chart? Statistical Analysis Tools, Techniques and SPC 6
H How do we prove that we are improving the continual improvement process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
L How do you prove you need resources? Misc. Quality Assurance and Business Systems Related Topics 5
J Finished Goods Testing - Using historical test data to prove finished goods OK Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
A Contract Review - How do you prove it? Contract Review Process 16
K Statistical Hypothesis Testing to prove signficant quality improvement or decline Statistical Analysis Tools, Techniques and SPC 6
J WAIVED ON Q1 - We Don't have to comply with FORDS customer specific requirements IATF 16949 - Automotive Quality Systems Standard 2
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
F What to do when you don't meet the 1:10 ratio Measurement Uncertainty (MU) 3
MDD_QNA Accessory or I-don't-know-what-to-call-it-at-this-point EU Medical Device Regulations 3
S ARMY AQL - Requirements which don't have an AQL associated with them Manufacturing and Related Processes 2
D First 510(k) Submission - Don't Forget Tips US Food and Drug Administration (FDA) 5
M IATF 16949:2016 clause 8.4.2.3 - We don't have ISO 9001:2015 certificate IATF 16949 - Automotive Quality Systems Standard 26
I "We don't have enough resources" as an Audit Non-conformance Response General Auditing Discussions 14
D PPAP a Rebranded Purchased Product (we don't manufacture) IATF 16949 - Automotive Quality Systems Standard 6
I Importing prototype without CE (dos and don'ts ) EU Medical Device Regulations 11
H Embedded Software - I don't understand that Calibration and Metrology Software and Hardware 2
N How to ensure our employees don’t grab and use the wrong materials Manufacturing and Related Processes 11
J We don't have enough Corrective action entries AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
L Nonconformity's risk is too low, so don't report it? General Auditing Discussions 25
K RAPS RAC - Resources to prep for the RAC exam that don't cost an arm and a leg Professional Certifications and Degrees 3
M A non-religious country, where you don't drink? Coffee Break and Water Cooler Discussions 14
Jim Wynne Don't Pay the Ransom Coffee Break and Water Cooler Discussions 11
AnaMariaVR2 Warning ? Don?t Confuse ?Made In USA? And ?Inspected By FDA? With Patriotism US Food and Drug Administration (FDA) 3
AnaMariaVR2 DIY Fixes Don't Meet CGMP: FDA Slams Manufacturer for Fixes Involving Tape, Rubber Ba Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
Stijloor American airports don't rank very well. Travel - Hotels, Motels, Planes and Trains 13
S Don't Forget Canadian Provincial Electrical Code Requirements Canada Medical Device Regulations 1
R EU-countries which don't accept English user manuals and require national translation CE Marking (Conformité Européene) / CB Scheme 9

Similar threads

Top Bottom