Risk Evaluation Guide for Pharmaceutical Excipients

Health and well-being have increasingly become our world’s focus as we turn over a new leaf into a new year. The pharmaceutical industry especially is at the forefront of ensuring that quality medications are brought out with minimal risks involved in health or to the industry as a whole. As businesses and the industry come together, business practices such as risk management principles, are now used by the pharma industry to help protect patients. And this focus on safety now has extended to pharmaceutical excipients as well.

For pharma excipients manufacturers, India, as much as the rest of the world holds a prominent place in terms of assessing risks involved in the sale of pharma products. This is where RanQ Excipients brings in its wealth of expertise and rigorous manufacturing conditions. High-quality standards, consistent performance, and monitoring of critical process parameters ensure that RanQ keeps its products in compliance with the current Good Manufacturing Processes or cGMP, WHO-GMP, ICH Q7 and IPEC.

Why is risk evaluation necessary?
Risk derived from excipients can be varied based on the route of administration that the drug product takes, to the function of the excipient. GMP requirements for excipients that may be binders or oral applications may be different than for those used as a stabilizer. Since excipients play such a vital role in the safety and clinical performance of drugs, risk evaluation becomes more important.

What are the parameters for risk evaluation?
Pharmaceutical excipients suppliers must keep these points in mind when risk evaluation is to be taken up:
1 – Use scientific knowledge to outline risks related to protecting the health of patients.
2 – Each excipient presents a different level of risk – so the level of documentation and formal effort presented in the quality risk management process or QRM should be based on the level of risk.

Dossier for Risk Evaluation
If you are a drug manufacturer, your risk management policy should include creating a dossier with information that accompanies each excipient. For pharma excipients manufacturers, India presents a market where information in such dossiers would consist of testing reports, supply chain information and alignment with regulatory guidelines.
Being one of the leading microcrystalline cellulose manufacturers in India, RanQ has ensured that it has a reliable supply chain for its worldwide customer group. Therefore it follows the standards of risk evaluation that is taken up by manufacturers the world over.

Process in a Nutshell
Risk is first identified, supplier information is brought out, and then some documents record compliant history. The evaluation process also checks whether there have been any recalls for the excipients and audit or inspection results are collated. This leads to a risk score rating.

Based on the risk scores, relevant quality practices in correlation with GMP are used and if the risk is ‘acceptable’ then the excipient can be put to the next stage.

After all these processes are completed, compliance monitoring is conducted on these excipients.
Risks have to be minimized when it comes to patient safety, and this has been taken into account here. The experts at RanQ ensure the right kind of processes for risk evaluation are carried, the information given here can serve as a guide to assessing risks for pharma excipient manufacturers.