Pharmaceuticals

Pharmaceutical drugs that are sold and marketed in the United States must be approved by the Food and Drug Administration (FDA) in some manner to ensure that the drug is safe and effective in its proposed use(s), and the benefits of the drug use(s) outweigh the risks.  These options include submission and approval of a New Drug Application (NDA) by a drug sponsor, the approval of a generic drug product through an Abbreviated New Drug Application (ANDA), or an Over-the-Counter (OTC) Drug Review (OTC monograph) process for a nonprescription drug.  The Center for Drug Evaluation and Research (CDER) is responsible for the approval and regulates OTC and prescription drugs. It is important to note that fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered drugs, and as such must meet all CDER regulatory requirements.

Regardless of the drug approval process utilized, the methods used in manufacturing the drug and the controls used to maintain the drug's quality must be adequate to preserve the drug's identity, strength, quality, and purity. This is accomplished by compliance to the pharmaceutical drug Current Good Manufacturing Practice (cGMP) requirements dictated in 21 CFR 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, and 21 CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.

Numerous FDA guidance documents, or a Guidance for Industry, have also been issued by the FDA to provide guidelines for the design, production, manufacturing, and testing of drug products. Several guidance documents also address how the FDA intends to conduct drug inspections and other enforcement activities.  A Guidance for Industry is the FDA’s “current thinking” on a particular subject. Remember the “c” in cGMP means current…

For generic and OTC drugs, it is also important that the drug product meets the quality standards provided in the United States Pharmacopeia – National Formulary (USP-NF). Quality standards in the USP-NF are organized into three types; monographs, general chapters, and material reference standards. A monograph is a written document that reflects the quality attributes of specific FDA approved drugs, while the general chapters address FDA accepted product development, laboratory, and manufacturing processes. USP-NF material reference standards are the primary standards used for all drug testing requirements. 

A quality management system (QMS) that dictates all controlled processes and procedures to consistently manufacture a drug product to meet the USP-NF quality standards, comply with the cGMPs, and meet the expectation of any applicable FDA Guidance for Industry is therefore necessary. TLC Regulatory and Laboratory Consulting can provide assistance with the development, improvement, and implementation of such a cGMP system.