§ Accreditation

Accreditation & quality system

HOKLAS-accredited laboratory. What is accredited, what is aligned, and what it means for your data.

§ 01 — Accreditation mark

HOKLAS accreditation

HKAS HOKLAS accreditation mark

ALS Analytical is accredited by the Hong Kong Accreditation Service (HKAS) under the HOKLAS scheme to ISO/IEC 17025:2017. Our accreditation covers chemical and microbiological testing of pharmaceuticals, peptides, and nutraceuticals. The full scope, schedule, and certificate number are available on request to clients and regulators.

Reports issued within the accredited scope carry the HOKLAS mark and are recognised under mutual-recognition arrangements including APAC MRA and ILAC MRA.

§ 02 — Quality pillars

Quality pillars

Q-01

HOKLAS accredited

Our laboratory holds HOKLAS accreditation under ISO/IEC 17025. Scope includes peptide purity, mass spectrometry, elemental analysis, and microbiological enumeration. Accreditation certificate and schedule are available on request.

Q-02

Method validation to ICH Q2(R1)

Every reported method has a documented validation package — specificity, linearity, accuracy, precision, LOD/LOQ, and robustness. Available under NDA.

Q-03

Instrument governance

Calibration on a documented schedule with system-suitability tests every run. Excursions logged, investigated, and cleared before results release.

Q-04

Data integrity (ALCOA+)

Attributable, legible, contemporaneous, original, accurate — plus complete, consistent, enduring, available. Audit trails on all electronic records.

§ 03 — Quality statement

Quality statement

Current practices at ALS Analytical.

Quality system
ISO/IEC 17025 · SOP-controlled · HOKLAS
Accreditation
HOKLAS · granted · certificate available on request
Method reference
ICH Q2(R1) · Q3D · Q1A(R2) · USP compendial
Signatories
Named, qualified, and version-controlled
Data retention
Raw data 5 yr · stability studies 10 yr
Confidentiality
NDA-first · no aggregated reporting
Deviation policy
Every excursion logged, reviewed, and disclosed

Note — HOKLAS accreditation is active. Reports issued within the accredited scope carry the HOKLAS mark. A copy of the current certificate and schedule is available on request.