Current overview of pharmaceuticals reference
standards
Critical types of reference standards
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 our insight on
critical types of reference standards used as experienced vendors in this
sector like us perform.
Different types of reference standards for testing
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 in giving the green signal to testing. They are:
Food and Drug
Administration, USA
v ICH guidelines Q 7, Q6 B
v Guidance documents
v FDA observations (ie like warning letters)
v USA pharmacopeia
European Agency for
Evaluation of Medical Products
v EU Quality guidelines 32 (regulatory submission)
v EU GMP 32, Annexe 18
v ICH guidelines Q 7, Q6 B
v European pharmacopeia
Additional Sources
v ISO guidelines 31, 32, 34
v WHO technical report series
v Benchmark of testing and findings of other firms
v Audit near misses
v 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 for chemical analysis and optimization,
validation and 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 synthesis. We are a one-stop solution for primary and secondary
standards for testing before drugs each the end consumer. Speak to us for your
chemical analysis and other testing needs.