Deconstructing crucial questions regarding
pharma impurities standards today
importance of quality
and risk management for drugs
There is a crucial
requirement to follow best practices regarding pharma impurities. It relates to
organic or inorganic substance presence while profiling the products. The
measurement of drug impurity standards is defined through residual solvents or
organic/inorganic material traces. The reasons range from chemical reactions to
ingredients and resulting synthesis. It is important to consider usp impurity
standards to measure APIs. There are exclusive companies that handle such cases
for the pharma industry.
SimSon Pharma Limited is
one of the reliable impurities suppliers in India fulfilling all criteria
related to quality and risk management for drug formulations. It is in the
business of tracing potential impurities and assists drug makers to reduce its
harmful aspects.
This blog opens up on our active participation to deconstruct crucial questions related to pharma impurities standards.
A reference
standard relates to:
·
Purity of the material of chemical, medical and pharma products
·
Characterized to suitability for formulation
·
Passes tests for identity, strength, quality and purity of the
substances
·
Reference standards are derived from USP or in-house.
They are important in the entire drug
making process for safety and end consumption.
Why is
impurity profiling mandatory by regulatory authorities?
In order to meet the reference
standards, the profiling consists of measuring:
·
Identification
·
Structure elucidation
·
Quantitative determination of impurities
·
Degradation in bulk drug materials
·
Pharm formulation
The regulatory authorities that are
involved include:
·
ICH
·
USD FDA
·
Canadian Drug and health agency
Checking for impurities
today is important to ensure that no toxic material is present in the drugs
which potentially can be harmful. At the formulation stage they are detected to
avoid problems with finished products. This ensures that the product is of good
quality and safe to use. This calls for quality and risk management for drugs which are produced by various
companies.
The usp impurity standards are different from
other reference standards. To ensure quality in developing and the entire
manufacturing process, this standard is required. Many independent labs are
involved in the testing procedure. This important procedure guarantees value
beyond the vial. USP is now the leading standard across the world.
Its benefits to generic drug makers are visible
due to:
1.
Acceleration
of development process and better analytical methods.
2.
Mitigating
the ANDA rejections by use of pharmacopeial products by FDA.
3.
Off-patent
drugs benefit all patients.
4.
Better
compliances for safe usage of drugs for long term.
5.
Minimizes
lab risks with better management.
6.
Save
time and resources to achieve results faster.
It is important to use the right reference standard for
measurement of impurities. A knowledge company assures pharma clients of the
best services and practices at reasonable rates.
If you would like to know more about how we
conduct the processes and adhere to the reference standards, please visit our
website or talk to us. As impurities suppliers in India, our company is
known to follow ICH guidelines which refer to Q3A (R), Q3B (R), and Q3C.