Quality Management System
Quality Management System
At DK Pharmachem, our Quality Management System is built in full alignment with ICH guidelines and is 21 CFR compliant, ensuring that our operations consistently meet stringent international quality requirements. Within this system, we conduct in-house Analytical Method Validation (AMV) and Process Validation (PV), alongside comprehensive stability and hold-time studies for APIs and intermediates.
Our Quality Control laboratory is equipped with advanced technology, while our Quality Assurance experts oversee every process with accuracy and precision. By integrating these systems, we not only achieve compliance but also guarantee reliability, reproducibility, and trust for every partner we serve worldwide.
ICH & 21 CFR
We meet the toughest global standards
AMV & PV
We validate and confirm every process
Quality Control
At DK Pharmachem, Quality Control is the backbone of our operations, ensuring that every product consistently meets the highest standards of safety, purity, and reliability. Our laboratories are equipped with advanced instruments such as IR, GC, HPLC, UV, and Karl Fischer systems, enabling precise monitoring and testing at every stage.
We conduct all analytical method validations, process validations, and both long- and short-term stability studies entirely in-house. With the support of our Analytical Development Lab and microbiology facilities, every API and intermediate is verified with accuracy, giving our partners full confidence in the consistency of our results.
Lab Equipment
IR, GC, UV, HPLC, Karl Fischer
In-House Labs
Precision testing across all batches
Accreditation
CEP (EDQM)
PMDA
TGA
MOH
NMPA & CDE
MFDS
AIFA
We have fi led CEP 8, 35 products are having Written confi rmation
WHO GMP certified
ISO 9001 - 2015 certified
EU written confi rmation certificates
Quality Excellence
QC
21CFR Part 11 compliant
State-of-the-art QC Department with latest equipment’s like IR / GC / HPLC / UV and Karl Fischer
In-house Long term and Short term stability studies
Drug Master File supported by our Quality Control division
Manufacturing & Documentation of Intermediates as per GMP norms
Quality Compliance of APIs for IP, EP, BP, USP, JP and CP
ADL
In-house Analytical Method Validation for APIs & Intermediates
RA & QA
Robust Regulatory and QA department ensures stringent quality control
APIs are manufactured as per ICH Q7A guidelines / GMP norms
ISO 9001-2008 certifi ed
Written confi rmation certifi cates
WHO GMP certified
SME 1 and D & B rating as 4A2
Successfully Audited by top Multinationals
QA is well versed with documentation and compliances