Virtual Company FDA Compliance

FDA’s May 2013 Guidance for Industry on Contract Manufacturing Arrangements for Drugs: FDA will hold a virtual company responsible for having caused the introduction of an adulterated drug into interstate commerce if it contracts for and markets a drug product made for it by a third party, but does not operate a quality system in compliance with cGMP to provide adequate oversight and control over the contractor. Under this concept, it would make no difference whether or not the contractor (that is, the actual manufacturer) happens to be in full compliance with cGMP – the virtual company would be out of compliance simply for failing to have the systems needed to provide the assurance.

FDA’s clear expectation is that the virtual company (the Owner, in the terminology of FDA’s Guidance) shares responsibility with the contracted manufacturing organization (CMO) for compliance. Contracted facilities have long been considered “an extension of the manufacturer’s own facility” as expressed in 21CFR 200.10, but what this requires in practice for virtual companies is somewhat uncertain. A virtual company clearly is expected to have a Regulatory/Quality unit with adequate authority and responsibility, and a minimum requirement is for the Owner (virtual company) to perform final release to market of each batch.

As the FDA draft Guidance explains, the Owner should conduct a risk review that evaluates the extent of controls required for the particular supplier. This should include determining the key performance indicators it believes necessary to control, and to develop systems for oversight. For a virtual company, this would include use of periodic compliance audits of CMOs, as well as review and approval of certain batch and process documentation; for example, batch records and certificates of analysis, manufacturing deviation and laboratory investigations, change control, continuous process verification, and annual product reviews.

Services provided to virtual companies include:

  • SOP Development
  • Quality Agreements
  • Vendor Audits
  • Mock FDA Inspections
  • Warning Letter & 483 Responses
  • Finished Product Market Release (for virtual manufacturers)
  • Continuous oversight of contract manufacturers
  • Annual Product Reviews
  • Due Diligence Assessments
  • Pharmacovigilance Services – agreements, intake calls, FDA Adverse Event Reports.