EXPERTISE
BNM Organics Pvt. Ltd. business commitment to certification and quality is of the highest priority. Our production facility is cGMP compliant and adheres to global quality manufacturing requirements.
We have a strong commitment to our environment and practice safe and hygienic waste disposal and recycling processes, besides nurturing a strong community environment policy. Our employees demonstrate high quality practices across the entire business cycle, thereby being instrumental in the safety and quality commitment of the company. Our entire product range is manufactured to meet the highest quality standards and conform to requirements as per :
British Pharmacopoeia (BP)
British Pharmaceutical Codex (BPC)
European Pharmacopoeia (EP)
Food Chemicals Codex (FCC, Version V)
Indian Pharmacopoeia (IP)
United StatesPharmacopoeia (USP)
BNM Organics supports all product enquiries and sales with extensive quality documentation that include :
Drug Master File in CTD Format
Analytical Specifications (AS)
Material Safety Data Sheet (MSDS)
Typical & batch-to-batch Certificate of Analysis (C.O.A)
Method of Analysis
BNM Organics works with its clients towards their respective Drug Authority Certification requirements and FCC product compliance, thereby ensuring a faster turnaround time in taking products to the market. Our facilities are currently under the process of expanding to compliance of European DMF and Certificate of Suitability for its selective products. Bihani Chemical advocates working in a transparent business environment.
PARAMETER
Regular Internal Audits for GMP occurs. Audits are performed by staff with adequate education, training and operations experience.
Routine environmental monitoring is conducted for Pathogens (Salmonella, Listeria swabbing and testing). The location and frequency of the sampling plan is documented.
The company operates a retention sample storage program for finished products and ingredients used. Retentions are kept at least until the stated expiry dates.
Documented procedures exist for inspection, clearance (& testing if necessary) of all raw and packing materials against purchase specifications. Clearance and testing of all finished products includes review of COA or reconfirmation of testing, packaging integrity, labeling and expiry date.
CERTIFICATIONS
  • 1
ISO 9001:2008 ISO 14001:2004 M Compliance Certificate L1 Compliance Certificatea