Quality & Compliance
How a batch is analysed, documented and released โ and what you receive with every shipment.
Home / Quality & Compliance
From Raw Material to Release
01 / Raw materials
Confirm the material and agreed specification before production.
02 / In-process checks
Follow the controls agreed for the product and process.
03 / Finished-product testing
Compare analytical results with the agreed product specification.
04 / Review & release
Review the data and connect the released lot to its documentation.
From Sample to CoA
01
Sampling
Retained sample pulled from the lot and logged against the batch record.
02
Analysis
Methods run against the agreed specification; out-of-spec results stop release.
03
Review
QC reviewer checks the data package and signs the CoA.
04
Release & retain
Material released, CoA issued, retention sample stored.
ใๅพ ๅฎขๆทๆไพ๏ผๆฃๆต่ฎพๅคๆธ ๅ๏ผๅ็งฐใๆฐ้ใๅๅทๅ่ชๆ/ๅงๅคๅฝๅฑ๏ผExcel๏ผ็จไบๆฃๆต่ฝๅ่กจใ
ใๅพ ๅฎขๆทๆไพ๏ผHPLC ๆนๆณๆธ ๅ๏ผ้็จไบงๅใๆนๆณ็ผๅทใ็ๆฌใๆฃๆต้กน็ฎไธ้ๅผ๏ผๅฏ่ฑๆ SOP/PDF๏ผ็จไบๆถฒ็ธๆฃๆต่ฏดๆใ
ใๅพ ๅฎขๆทๆไพ๏ผGC ๆนๆณๆธ ๅ๏ผ้็จไบงๅใๆนๆณ็ผๅทใ็ๆฌใๆฃๆต้กน็ฎไธ้ๅผ๏ผๅฏ่ฑๆ SOP/PDF๏ผ็จไบๆฐ็ธๆฃๆต่ฏดๆใ
ใๅพ ๅฎขๆทๆไพ๏ผKF ๆนๆณๆธ ๅ๏ผ้็จไบงๅใๆฐดๅๆต่ฏๆนๆณ็ผๅทใ็ๆฌไธ้ๅผ๏ผๅฏ่ฑๆ SOP/PDF๏ผ็จไบๆฐดๅๆฃๆต่ฏดๆใ
ใๅพ ๅฎขๆทๆไพ๏ผๆปดๅฎๆนๆณๆธ ๅ๏ผ้็จไบงๅใๆปดๅฎ้กน็ฎใๆนๆณ็ผๅทใ็ๆฌไธ้ๅผ๏ผๅฏ่ฑๆ SOP/PDF๏ผ็จไบๅซ้ๆฃๆต่ฏดๆใ
ใๅพ ๅฎขๆทๆไพ๏ผ็ๆ ทๆ้๏ผๅไบงๅ็ๆ ทๆถ้ฟใๆฐ้ใๅจๅญๆกไปถๅ่ตท็ฎๆฅ๏ผSOP ๆ่ฆๆ่ด่ดฃไบบ็กฎ่ฎคๆๅญ๏ผ็จไบ็ๆ ทๅถๅบฆ่ฏดๆใ
ใๅพ ๅฎขๆทๆไพ๏ผOOS ๅค็๏ผ่ถ ๆ ็ปๆ็ๅคๆ ธใ่ฐๆฅใๅฎกๆนใๅค็ฝฎๅๅฎขๆทๆฒ้ๆต็จ๏ผSOP ๆ่ฆ๏ผ็จไบๅผๅธธ็ปๆ่ฏดๆใ
ใๅพ ๅฎขๆทๆไพ๏ผๆพ่กๆ ๅ๏ผๅไบงๅ้็จ่งๆ ผใ้ๅผใๅคๅฎ่งๅๅๆนๅ่ดฃไปปไบบ๏ผๅฏ่ฑๆ่งๆ ผ่กจ/PDF๏ผ็จไบๆนๆฌกๆพ่ก่ฏดๆใ
ใๅพ ๅฎขๆทๆไพ๏ผๅฏๅ ฌๅผๆฃๆตๆ ทๆฌ๏ผไธ่ฎพๅคๅๆนๆณๅฏนๅบ็่ฑๆๆฃๆต่ฎฐๅฝๆๆฅๅ PDF๏ผ็จไบ่ดจ้่ฝๅไธพ่ฏใ
Methods & Laboratory
The test panel follows the product and your specification. Instrument availability and method summaries are confirmed during supplier qualification.
ๅพ ๅฎขๆทๆไพ๏ผ่ฎพๅคๅๅทใ่ชๆๆๅงๅคๅฝๅฑใๅฏนๅบไบงๅ็ๆฃๆตๆนๆณๅๅฏๅ ฌๅผๆ ทๆฌใ
What Is Checked Before a Lot Is Released
The test panel follows the product and your specification. This is the typical structure, not a fixed list of limits.
Check ยท Applies to ยท How it is verified ยท Where it is recorded
Identity
Every lot
FTIR or NMR against an authenticated reference
CoA + analytical file
Assay / purity
Every lot
HPLC area% or titration, depending on the product
CoA
Impurity profile
Every lot
HPLC area normalisation; individual and total impurities
CoA
Water content
Where the specification sets a limit
Karl Fischer titration
CoA
Residual solvents
Where the route uses class 1/2 solvents
GC headspace
CoA or statement
Appearance
Every lot
Visual against the reference sample
CoA
Heavy metals / elemental
On request or per customer spec
ICP-MS or ICP-OES
CoA
The parameters and limits applied to your order are the ones in the quotation and the specification sheet โ not a generic list.
What We Control Before Release
The product page gives you the specification. This page explains how we prove it, lot after lot.
01
In-house QC laboratory
Every lot is analysed before release: HPLC purity, GC residual solvents, Karl Fischer water, titration and melting point where the specification requires it.
02
Batch traceability
Each batch carries a lot number tied to raw-material receipts, process records, analytical data and retention samples kept for the agreed period.
03
Certificate of Analysis
A CoA is issued per lot with the tested parameters, specification limits, results and methods used. Customised CoA formats are available on request.
04
Supplier qualification
Suppliers are qualified on documentation, sample analysis and audit history before their material enters a customer order.
Samples We Keep
Retention samples let a dispute be settled months after delivery instead of by argument.
Retention sample
A sample from every released lot is stored under label, lot number and release date. Retention period follows the agreement with the customer; where none is agreed, the internal standard applies.
Stability
Where a product has a defined retest period, it is stated on the TDS. Products without one are treated as stable under the storage conditions on the SDS, and re-analysed on request before a repeat order ships.
Management Systems & Registrations
Certificates are provided as PDF on request; the numbers below are being updated with the current copies.
ISO 9001
Quality management
ISO 14001
Environmental management
GMP
Where applicable to the product
REACH
Registration status by substance
When a Result Fails
An out-of-specification result stops the release. There is no discretionary override on the shop floor.
01
Retest
The sample is re-prepared and re-injected to rule out an analytical error.
02
Investigation
If the result repeats, the batch is investigated: raw materials, process deviation, equipment.
03
Decision
The lot is either reworked under a documented procedure or rejected; it is never released as-is.
04
Customer contact
If the lot was already allocated to you, we tell you before shipment and offer the options.
Quality Questions We Get Asked
Can you provide a CoA before we place the order?
Yes. Send the product and the specification you need to meet; we return a sample CoA from a recent lot, and the final CoA is issued for the lot we ship.
What happens if my test result differs from your CoA?
Send your analytical data and the method used. We compare against the retained sample and the release data, then either re-test or replace the material.
Do you support customer audits?
Yes, subject to scheduling and an NDA. We share the QC records, retention-sample policy and supplier qualification process for the products you buy.
Request a CoA, TDS or SDS
Tell us the product and the document you need. If a document does not exist yet for that product, we say so instead of sending a generic sheet.
Can’t Find the Chemical You Need?
Share the product name, CAS number or specifications so we can assess sourcing or custom development options.
Freemind Pharma & Chemicals Co., Ltd.
Address
Zone D, Mingxi Economic Development Zone, Mingxi County, Sanming, Fujian, China
Phone / WhatsApp
Geng +86 186 1261 8569
Zhang +86 135 9939 7867
WhatsApp +86 152 4962 7274
Mingxi Economic Development Zone Sanming, Fujian ยท Open in Maps