What are requirements of SISPQ in Pharmaceutical industry?

SISPQ is a foundational principle in the pharmaceutical industry, ensuring that drugs are safe, effective, and of the highest quality, meeting both regulatory standards and patient needs.

In previous article on SISPQ We discussed about the details having introductory information on SISPQ in pharmaceutical industry. Now we will go through with the requirements of SISPQ, to ensure and to follow the SISPQ elements in routine manufacturing and compliance point of view.

Fig. 1: SISPQ in Pharmaceutical Industry

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This article contains;

Requirements of SISPQ…??

How to meet the requirements….??

Key points for consideration of SISPQ elements..??

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Under the pillars of SISPQ, pharmaceutical manufacturing is very much valuable, efficacious, as these elements ensure the safety and efficacy of pharmaceutical products throughout the pharmaceutical product lifecycle starts from Drug development, manufacturing, storage, distribution and marketing. Have a look on the requirement of SISPQ in Pharmaceutical industry.

Requirements of SISPQ

These are the key requirements of SISPQ in pharmaceutical industry to execute during product development and manufacturing. By meeting these requirements, pharmaceutical companies ensure that their products are safe, effective, and of high quality, meeting both regulatory standards and patient needs, as per the intended use.

Fig.: 2 Requirement of SISPQ in Pharmaceutical Industry

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How to meet the requirements……?????.

Answers is various Regulatory and Industry Standards are established by various regulatory authorities all over the world, to guide and fulfil the requirement of SISPQ in the pharmaceutical Industry.

FDA Guidelines: Following the U.S. FDA's Current Good Manufacturing Practices (cGMP) regulations, outlined in 21 CFR Parts 210 and 211..

EMA Guidelines: Adhering to the European Medicines Agency (EMA) guidelines, including those for quality, safety, and efficacy.

ICH Guidelines: Complying with International Council for Harmonization (ICH) guidelines, such as ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality System).

ISO Standards: Meeting relevant ISO standards, particularly ISO 9001 (Quality Management Systems) and ISO 13485 (Quality Management Systems for Medical Devices).

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Key points for consideration of SISPQ elements

✍ Implementing thorough risk assessments during drug development, including potential hazards and their impact on patient safety

✍Conducting preclinical toxicology studies to assess potential safety risks.

✍Ensuring that clinical trials are designed to identify safety issues, with continuous monitoring of adverse events.

✍Establishing a robust pharmacovigilance system for ongoing safety monitoring once the product is on the market.

✍Providing clear safety information, including warnings, precautions, and contraindications on product labelling.

✍Ensuring the correct Active Pharmaceutical Ingredient (API) is used, verified through analytical techniques like High-Performance Liquid Chromatography (HPLC) or Mass Spectrometry.

✍Implementing strict control over raw materials and excipients to ensure they meet identity specifications.

✍Ensuring consistency across batches by applying validated processes and controls.

✍Maintaining detailed documentation that confirms the identity of each component used in production

✍Ensuring that each unit of the pharmaceutical product contains the exact amount of API (Dose) as specified on the label.

✍Conducting content uniformity tests to confirm that the strength is consistent across different units of the same batch.

✍Applying in-process controls during manufacturing to monitor and adjust the API concentration as needed.

✍Using validated analytical methods to test the strength of the final product.

✍Setting and adhering to strict limits for impurities, including chemical, physical, and microbiological contaminants.

✍Monitoring and controlling degradation products that could form during storage.

✍For sterile products, ensuring the absence of viable microorganisms through validated sterilization processes.

✍Implementing environmental monitoring in manufacturing areas to control contamination sources.

✍Adhering to GMP guidelines to ensure that products are consistently produced and controlled according to quality standards.

✍Performing rigorous QC testing on raw materials, in-process materials, and finished products.

✍Establishing QA systems to oversee the entire manufacturing process and ensure compliance with regulatory standards.

✍Conducting stability testing to determine the product’s shelf life and ensure it maintains its quality over time.

✍Implementing QbD principles to design quality into the product and process from the beginning.

✍Ensuring compliance with all relevant regulatory requirements, including submitting necessary documentation for approval and maintaining records.

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Conclusively, Implementing the SISPQ principles within pharmaceutical operations brings substantial benefits, ensuring that products are not only safe and effective but also consistently meet the highest quality standards.

By rigorously adhering to SISPQ guidelines, companies can minimize risks, reduce variability in production, and enhance patient trust. This robust framework supports regulatory compliance, accelerates product approval processes, and fosters a culture of continuous improvement.

In the end, SISPQ isn’t just about meeting regulatory requirements—it’s about protecting patients, upholding industry standards, and contributing to the overall success of the company.