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Despite the lack of an explicit GMP requirement, some firms may elect to use HEPA filtered air systems as part of their dust control procedures.For example, firms may perform dust containment assessments and decide that such filters are warranted to prevent cross contamination of highly potent drugs that, even in small quantities, could pose a significant health hazard when carried over into other products. Dioctyl phthalate aerosols also called Di (2-ethylhexyl) phthalate, di-sec octyl phthalate, DOP, or DEHP, have long been used to test the integrity of HEPA filters but concern about the potential health effects to people working with DOP test aerosols has led to a search for a safer equivalent replacement.In addition, this section calls for use of air filtration systems, including prefilters and particulate matter air filters on air supplies to production areas, as appropriate.These provisions speak to measures to prevent cross contamination, and the key phrase is "when appropriate".Note that replacing an existing method is not the same as adding a new method to a release or stability test panel.
§ 342(f)] unless it meets one of two requirements:2.We reviewed your website at the Internet address January 2014. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. As such, we are unable to determine the adequacy of your proposed corrective actions at this time.and we have determined that you take orders there for your Bio Rhythm Olio and Re Generate products, which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U. Your Bio Rhythm Olio and Re Generate products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 U. You did not prepare a written Master Manufacturing Record (MMR) related to your packaging and labeling operations, as required by 21 CFR 111.205.Assume the API is properly stored in an appropriate environment, but no further testings after entry. I understand that we should keep the batch of drug product for stability monitoring. Why did you extend the shelf life of the raw material?Any supporting guidelines or argument that we can follow. For raw material, you mean we should sample enough amounts for testing througout the extended shelf life? Was your retesting appropriate (did you perform Assay, Related Substances, Moisture...)?