Introduction
Pharmaceutical Laboratory as one of the subdivisions of FDCRL is responsible for physicochemical and microbiological quality control of drugs in different stages: first manufactured /imported batch, periodical sampling, and Post Marketing Quality Controls (PMQC), claim and complaints samples.
Samples which are evaluated by laboratory experts include Active Pharmaceutical Ingredients (APIs) and diverse dosage forms such as:
Tablets, Capsules, Syrups, oral and ophthalmic Drops, Injectable, Creams, Ointments, Gels, Suppositories, oral Suspensions and Emulsions, Enema and Topical solutions.
 
Personnel expertise
Ph.D. in Medicinal Chemistry, Pharmaceutics, Drug Control
Pharm D. 
M.S. in Organic Chemistry
 
Scope
In addition to QC testing on the referred samples from IFDA, Pharmaceutical Laboratory is also engaged in the following activities:
  • Regular GLP inspection of QC labs of domestic & foreign manufactures, affiliated medical universities and accredited / collaborative labs.
  • Participation in Quality Assurance related activities, such as training, SOP writing and preparation of: job descriptions, VMP, CAPA reports and other relative activities.
  • Participation in proficiency testing programs, such as WHO, WINAP and EDQM.
  • Establishment of national standards such as Iranian Pharmacopoeia.
  • Participation in IFDA Projects and research QC programs in order to develop/modify analytical methods and methods validation.
  • Statistical and activity reports to governmental authorities.
 
 
 
Technical Instrument
  • HPLC
  • GC
  • Potentiometer
  • pH meter
 
Analysis & Tests
A-Physicochemical Analysis:
  1. General Tests: pH determination, water content, loss on drying, tablet hardness and friability, disintegration, viscosity, density, refractive  index, optical  rotation, melting point, heavy  metals, sulphated  ash,  residual  solvents, limit tests.
 
  1. Specific Tests: Identification, Assay of active ingredients, Assay /Determination of   Impurities and Related substances, Dissolution.
 
B- Microbiological Analysis: Sterility test, Microbial limit tests, Microbial assay of antibiotics and Bacterial Endotoxin Testing (BET).
 
International Certificates
  1. WHO Prequalification for Quality Control Laboratory, since 2016.
  2. Membership in pharmaceutical Inspections Scheme (PIC/S), since 2018.