CONTRACT MANUFACTURING
SECTION TITLE
stabilizer is justified (for instance the use of mannitol as free-radical scavenger or cysteine in paracetamol solution for injection), it should be included at the minimum concentration demonstrated to be efficient at release and during the entire shelf-life.3
In the cases of powders for injection or infusion obtained through a freeze-drying process, the use of bulking agent (such mannitol) and/or a cryoprotector will be needed when the dose of drug substance(s) cannot ensure solely the formation of acceptable “cake”.
Finally the process of the sterilization should be selected according to the characteristics of the parenteral preparations (for instance, heat steam sterilization for aqueous solutions and dry heat for non-aqueous solutions), but in any case it can be justified by the nature of the primary containers.4
Figures 1 and 2
display the decision trees for the selection of the sterilization process for aqueous products or non-aqueous solutions including semi-solid and dry powder products.
The efficiency of the selected sterilization process should be demon-strated through validation studies, using the appropriate biological indicators, to ensure an ASL (Assurance Sterility level) of 10-6
.1 Solutions
Roquette has developed a pyrogen-free range of products with high pharmaceutical standards and being biocompatible for the manufacture of parenteral preparations, All these pyrogen- free range of products are obtained from natural and renewable raw materials. Besides their compliance to pharmacopeias and other ICH quality requirements (for instance ICHQ3D for elemental impurities), all these pyrogen-free products, even when used as excipients, are manufactured in compliance to GMP, ICHQ7, and certified by competent authorities (ANSM the French Competent Authority and US FDA).
Conclusion
Parenteral preparations are sterile and pyrogen-free preparations intended to be administered directly into the systemic circulation in human or animal body. They should meet the pharmaceutical quality standards as described in pharmacopeias and ICH guidelines and also ensure the clinical tolerance as well as to be safe for the intended purpose of use.
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References
1. EP, USP and JP Pharmacopeias 2. ICH Q6, Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products 3. ICH Q8, Pharmaceutical development
4. Decision trees for the selection of sterilization methods (CPMP/QWP/054/98)
5.
www.roquettepharma.com
Elham Blouet, Pharmacist with several years of experience in industrial pharma companies and health authorities agency. She joined Roquette in 2007 with a current position as Global Market
Manager (Injectable & Dialysis) in the Global Business Unit , Pharma & Health.
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pharmoutsourcing.com | 15 | November/December 2016
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