New FDA Draft Guidance - Microbiological Quality Control of Non-Sterile Medicinal Products

As a part of the news from CBER, the FDA published a new draft guidance on 30 September that is intended to help manufacturers of non-sterile medicinal products with microbiological quality control. It covers non-sterile solid, liquid and semi-liquid dosage forms (NSDs) such as topically applied creams, lotions and swabs, as well as oral solutions and suspensions. These may be prescription or non-prescription medicines as well as new drugs.

The FDA Guide applies to finished medicinal products and APIs

The aim of the recommendations in this document is to assist manufacturers in complying with the requirements of current good manufacturing practice (CGMP) for finished medicinal products and active pharmaceutical ingredients (APIs). To this end, product development considerations and risk assessments are addressed, and specific CGMP issues that are particularly relevant to microbiological control in the manufacture of NSDs are discussed. Risk assessment in general and specifically the risk of contamination of NSDs with undesirable microorganisms will also be included. It is intended to assist in establishing appropriate specifications and manufacturing controls to prevent such contamination of the medicinal products and to ensure the safety, quality, identity, purity and efficacy of the NSDs. For new drug products (NDAs and ANDAs), there are specific explanations on how the specified controls should be submitted in the applications to the Authority and in what form changes in microbiological specifications and testing programmes should be reported. To better illustrate and explain how a risk identification and assessment and a corresponding control strategy can be established, case studies are included. These comprise e.g. incidents with Burkholderia cepacia complex (BCC) and other microorganisms that caused contamination in non-sterile dosage forms and that led to adverse events and recalls of the medicinal products.

The New Guidance reflects the lessons learned from the FDA Adverse Event Reports (FAERs) and recalls due to contamination. From 2014 to 2017, 197 FDA Adverse Event Reports were recorded that were related to bacterial or fungal contamination, of which 32 were classified as serious adverse events. As the reporting is voluntary, the FDA assumes that the number of unreported cases is significantly higher.

For more details, please refer directly to the draft guidance Microbiological Quality Considerations in Non-sterile Drug Manufacturing, which is open for comment until 29 November 2021 via the FDA's dedicated website.

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