When we discuss the
pharmaceutical manufacturing, SISPQ is very important topic of discussion. It adheres
the basic principle and objective of Pharmaceutical Manufacturing i.e.
“The
pharmaceutical industry aims to guarantee patient safety by producing a safe
product which has been tested according to the highest standard of current
scientific knowledge and which is approved by the authorities.”
The SISPQ fulfill the
requirements of “Good manufacturing practice (GMP)” set by the various
regulatory agencies all over the world.
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| Elements of SISPQ |
Elements of SISPQ
In simple words if we
see SISPQ full form, SISPQ stands for Safety, Identity, Strength, Purity,
and Quality.
# Safety:
Ensuring that the drug is safe for patients to use, with minimal risk of
adverse effects or harm.
# Identity:
Confirming that the drug is indeed what it claims to be, with accurate labeling
and proper identification.
# Strength:
Verifying that the drug contains the correct amount of active ingredients as
specified.
# Purity:
Ensuring that the drug is free from impurities, contaminants, or other unwanted substances.
# Quality:
Meeting the highest standards of manufacturing, packaging, and distribution to
deliver effective and reliable medications.
Advantages
of SISPQ
The cGMPs as described
by FDA in 21 CFR 210
and 211
(and others as applicable) are the minimum requirements necessary to
demonstrate that the drug products meet Elements of SISPQ.
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| Advantages of SISPQ |
Conclusively,
Adhering to Safety, Identity, Strength, Purity and Quality (SISPQ) standards in pharmaceutical manufacturing has numerous advantages across the industry. By prioritizing patient safety, ensuring regulatory compliance and enhancing product efficacy, pharmaceutical companies can build trust, maintain market competitiveness and safeguard public health.
Moreover, robust
quality control measures not only mitigate risks and enhance supply chain
integrity but also drive operational efficiency, cost savings, and continuous
improvement. As the pharmaceutical landscape evolves, a steadfast commitment to
elements of SISPQ.
Principles of SISPQ remains paramount for meeting regulatory
requirements, exceeding customer expectations, and advancing global healthcare
outcomes.
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