Dear Rishabh,
Stability studies are playing main role in the pharmaceutical industry. Stability studies for pharmaceutical drug products are having all guidelines like ICH, USFDA, EMEA, WHO and etc. Hold time study data shall give the assurance the maximum allowable hold times for bulk and in-process drug products. Generally one lot can be used for validating hold times if any inconsistency results were observed then another two lots can be used for this study. Major hold study required stages are mixing, blending, lubrication, binder solution, coating solution, uncoated tablets, coated tablets, filled capsules, syrup solution, power for injection, liquid injection, bulk creams/ointments/gels. Hold study samples need to pack with the regular used poly ethylene bags, sterilized containers, HDPE or Glass containers. Hold samples need to store at GMP conditions i.e. where the lot or stage holds in the manufacturing area. All the regulatory agencies also may expect the hold time study at critical stages to understand the trend of degradation during holding at in-process stages.
http://www.omicsgroup.org/journals/hold-time-stability-studies-in-pharmaceutical-industry-review-2167-7689.1000104.pdf
Manufacturers should ensure that the products that they manufacture are safe, effective and of the quality required for their intended use. Products should be consistently manufactured to the quality standards appropriate to their intended use and as required by the marketing authorization. Systems should ensure that pharmaceutical products are produced according to defined procedures that are validated and monitored. Manufacturing processes should be shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications. Arrangements should exist to ensure that the materials used, intermediate products, bulk and finished products are stored under appropriate conditions. Storage should not have any negative effect on the processing, stability, safety, efficacy or quality of the materials, intermediate products, bulk and finished products. Good manufacturing practices require
that the maximum allowable hold time should be established to ensure that in-process and bulk product can be held, pending the next processing step, without any adverse effect to the quality of the material. These time periods must be supported by adequate data to demonstrate that the product will be stable throughout the approved shelf-life. Normally bulk products should not be stored for a period of 25% or more of the approved shelf-life (prior to packing into the final containers) unless these are tested, with stabilityindicating methods, prior to packaging.
http://www.who.int/medicines/areas/quality_safety/quality_assurance/GeneralGuidanceHoldTime-QAS13-521_20022013.pdf
Hoping this will be helpful,
Rafik
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