Storage drug product

Determination of the drug substance is expected to be enantioselective, and this may be achieved by including a chiral assay in the specification or an achiral assay together with appropriate methods of controlling the enantiomeric impurity. For a drug product where racemization does not occur during manufacture or storage, an achiral assay may suffice. If racemization does happen, then a chiral assay should be used or an achiral method combined with a validated procedure to control the presence of the other enantiomer. 

Data to demonstrate the stability characteristics of both the drug substance and the drug product must be collected. Studies using three different batches of both substance and product in their respective containers/packaging must be conducted. Real-time data should be collected under conditions of temperature and relative humidity in line with the recommended storage. Conditions in different world climatic zones must be taken into consideration for cases where normal environmental... 

Batches should be tailor-made for the proposed trial, and should be labelled with information as appropriate regarding the product, sponsor, investigator, subject and trial, together with the statement For clinical trial use only . In addition, where the medicine will be used outside ofthe clinical site, the statement Keep out of reach of children should be added. There should be full accountability for the distribution, storage and fate of the drug product at both the manufacture and trial sites. 

Sec. 211.82 Receipt and storage of untested components, drug product containers and closures. Sec. 211.84 Testing and approval or rejection of components, drug product containers and closures. 

Storage of released components, drug product containers, ciosures, and iabeiing ... 

Quarantine storage before release of drug products ... 

Components, drug product containers, and closures shall be retested or reexamined, as appropriate, for identity, strength, quality, and purity and approved or rejected by the quality control unit in accordance with 211.84 as necessary, e.g., after storage for long periods or after exposure to air, heat or other conditions that might adversely affect the omponent, drug product container, or closure. 

Product-related substances are molecular variants of the desired product formed during manufacture and storage, which are active and have no deleterious effect on the safety and efficacy of the drug product.2 Many recombinant protein products are inherently heterogeneous, mixtures of closely related structures or product variants. These variants possess properties comparable to the desired product and are not considered impurities. It is only when they do not have properties of the desired product that their presence is problematic. 

A stability-indicating method is a validated quantitative analytical procedure that can detect the changes with time in the pertinent properties of the drug substance and drug product under defined storage condition. A stability-indicating assay method accurately measures the active ingredient(s) without interference from other peaks and is sensitive... 

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