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.
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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