Quality Management System Ensuring Global Pharmaceutical Compliance
Quality Control l Regulatory and QA Department
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
Accreditation
CEP (EDQM)
PMDA
TGA
MOH
NMPA & CDE
MFDS
AIFA
We have filed CEP 835 products are having Written confirmation
WHO GMP certified
ISO 9001 - 2015 certified
EU written confirmation certificates
Quality Excellence
Our team excels in implementing and maintaining rigorous QMS knowledge that
drive
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
RA & QA
Robust Regulatory and QA department ensures stringent quality control
APIs are manufactured as per ICH Q7A guidelines / GMP norms
ISO 9001-2008 certified
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
ADL
In-house Analytical Method Validation for APIs & Intermediates
Frequently Asked Questions
As a CDMO What quality certifications does DK PharmaChem hold for API manufacturing?
DK PharmaChem holds WHO Good Manufacturing Practice (WHO-GMP) certification, ISO 9001:2015 certification and European Union (EU) Written Confirmation certificates for API exports. Its Quality Management System is aligned with International Council for Harmonisation (ICH) guidelines, and APIs are manufactured under ICH Q7A GMP norms. Quality Control operations are compliant with 21 CFR Part 11.
Which regulatory authorities have accredited or approved DK PharmaChem?
DK PharmaChem lists accreditations or approvals associated with the European Directorate for the Quality of Medicines (EDQM) through its Certificates of Suitability (CEP), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Australia’s Therapeutic Goods Administration (TGA), the Ministry of Health (MOH), China’s National Medical Products Administration (NMPA) and Center for Drug Evaluation (CDE), South Korea’s Ministry of Food and Drug Safety (MFDS) and Italy’s Agenzia Italiana del Farmaco (AIFA). Approvals are product-specific, so buyers should confirm the status of each molecule.
Which pharmacopoeia standards do DK PharmaChem's APIs comply with?
DK PharmaChem’s APIs are quality compliant with the Indian Pharmacopoeia (IP), European Pharmacopoeia (EP), British Pharmacopoeia (BP), United States Pharmacopeia (USP), Japanese Pharmacopoeia (JP) and Chinese Pharmacopoeia (CP). Compliance is confirmed per product, so buyers should state the required monograph when requesting a quotation.
What testing, validation and stability capabilities does DK PharmaChem have in-house?
DK PharmaChem’s Quality Control laboratory is equipped with IR, GC, HPLC, UV and Karl Fischer instruments. The company conducts in-house Analytical Method Validation (AMV) and Process Validation (PV) for APIs and intermediates. It also runs long-term and short-term stability studies and hold-time studies. These capabilities support consistent, reproducible batches and the data packages buyers need for qualification.
What regulatory documentation does DK PharmaChem provide to buyers?
Documentation depends on the product. DK PharmaChem’s Quality Control division supports Drug Master Files (DMF), and Certificates of Suitability (CEP) and Written Confirmation certificates are available for relevant products. Buyers can request specifications, certificates of analysis, validation summaries and stability data. Please share the product name and target market so the team can confirm which documents apply.