Current overview of pharmaceuticals reference standards

Author : banarjee sherie | Published On : 16 Jan 2022

 

What exactly is a pharmaceutical reference standard?

When a highly purified sample of a specific compound is characterized to measure the accuracy of the content, it is referred as the pharmaceutical reference standard. It is the platform for quantitative and qualitative testing.

SimSon Pharma Limited is a well established company dealing in reference standards, research chemicals and allied research services. All our standards are sourced from various templates chosen from domestic and international certified manufacturers. We offer certifications and reference standard for chemical analysis catering to chemists and pharma companies. 

This blog offers an insight on critical reference standards traded by experienced vendors in this sector like us..

  

Control strategy for drugs

A drug not only has to be potent for consumption but also has to meet the quality of medicinal value for a patient. This is why control strategy is critical as it adds to the strength of cGMP testing and release in the system. It is vital for all products which also undergo reference standard for medical research through professional companies. There are various regulatory authorities that are involved inassuring the safety, efficacy, and supervision of human and veterinary drugs. They are:

Food and Drug Administration, USA

  1. ICH guidelines Q 7, Q6 B
  2. Guidance documents
  3. FDA observations (ie like warning letters)
  4. USA pharmacopeia

European Agency for Evaluation of Medical Products

  1. EU Quality guidelines 32 (regulatory submission)
  2. EU GMP 32, Annexe 18
  3. ICH guidelines Q 7, Q6 B
  4. European pharmacopeia

Additional Sources

  1. ISO guidelines 31, 32, 34
  2. WHO technical report series
  3. Benchmark of testing and findings of other firms
  4. Audit near misses

 

  1. Internal QA/QC audits

Reference standards are considered as an integral part of any pharma’s product strategy. They are unique and specific to certain drugs as more regulations are required. The testing controls the portions of drugs but they are not drugs which have a different intent.

SimSon advantage to minimize risks

  • Stringent business process for reference standard employed in  chemical analysis and optimization, Method validation and Method transfer. 
  • Rapid development of qualifying products, metabolites and any unusual impurities.
  • Our services include standard preparation, identification and responsive factors found in dosages.
  • Formulation development and testing it.
  • We handle high barrier process for complex custom synthesis.
  • We service reference standards for worldwide and domestic clients.
  • Our facility is equipped to handle controlled substances, store after manufacturing process.
  • Custom packaging for overseas clients.

SimSon follows all regulatory requirements related to the critical pharma sector.  We supply certificates for pharma impurities, APIs and custom synthesized products. We are a one-stop solution for primary and secondary standards for testing before drugs reach the end consumer. Speak to us for your chemical analysis and other testing needs.