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Drug product packaging

The FDA approved label is the official description of a drug product and includes what the drug is used for who should take its adverse events (side effects) instructions for use in pregnancy, children, and other populations and safety information for the patient. Labels are often found inside drug product packaging. [Pg.491]

Marketed Drug Product Packaged in Semipermeable Containers ... [Pg.569]

Drug Products Packaged in Impermeable Containers For drug products packaged in impermeable containers that provide a permanent barrier, moisture or solvent loss is not a concern and for such products stability studies can be conducted under any controlled or ambient humidity conditions. [Pg.570]

The specifications for drug substance, drug product, packaging components, excipients, and so on will be established based on sound technical justification, using a continuously expanding experience base that includes information on process, product, analytical methods, stability of drug substance and produces), packaging components, and so on. [Pg.397]

Stability testing A brief description of the stability study and the test methods used to monitor the stability of the drug product packaged in the pro-... [Pg.63]

Provide a detailed description of the physical, chemical, and if applicable, biological characteristics of the container, closure, or other component parts of the drug product package to assure suitability for its intended use. Acceptance specifications and test methods performed by the drug product manufacturer for each packaging component should be spelled out. [Pg.208]

For nearly 33 years, the USP has been reporting programs for health care professionals to share experiences and observations about the quality and safe use of medications. This year, the USP Center for the Advancement of Patient Safety publishes its sixth annual report to the nation on medication errors reported to MED MARX (Table 6). It was observed that drug product packaging/labeling is one of the main courses of medication errors in hospitals. [Pg.195]

Another component in postmarketing safety surveillance programs is the establishment of enforcement mechanisms to correct product problems. Errors can occur in drug production, packaging, and shipping that lead to adulteration, loss of potency, mislabeling, and other hazardous situations. Prompted by user reports or by results of their own internal quality control procedures, drug manufacturers routinely initiate voluntary product recalls. These actions typically involve limited quantities, or batches, which are cited in public notices of recalls published by the FDA. Product problems that represent serious and widespread threats to public health evoke another form of official publication Public Safety Alerts (entitled Public Safety Reports in Europe). [Pg.118]

Stability testing A brief description of the stability study and the test methods used to monitor the stability of the drug product packaged in the proposed container/closure system and storage conditions should be submitted. Preliminary tabular data based on representative material may be submitted. Neither detailed stability data nor the stability protocol need to be submitted. [Pg.61]

Laminated aluminum foils are increasingly being used to protect drug products packaged in semipermeable containers (e.g, low-density polyethylene... [Pg.149]


See other pages where Drug product packaging is mentioned: [Pg.568]    [Pg.570]    [Pg.578]    [Pg.592]    [Pg.654]    [Pg.671]    [Pg.11]    [Pg.11]    [Pg.19]    [Pg.172]    [Pg.158]    [Pg.36]    [Pg.37]    [Pg.345]    [Pg.305]    [Pg.490]   
See also in sourсe #XX -- [ Pg.11 , Pg.18 , Pg.19 , Pg.20 , Pg.21 , Pg.22 , Pg.23 , Pg.24 , Pg.25 , Pg.26 , Pg.27 , Pg.53 ]




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DRUG PACKAGING

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