Know the Regulations - Pharmaceutical Technology

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Know the Regulations
The contract provider needs to know as much as the NDA holder.


Pharmaceutical Technology
Volume 36, Issue 4, pp. 138-139


Susan J. Schniepp
Auditing a firm's complaint and out-of-specification systems have always been favorite areas for regulators to assess to determine the compliance, effectiveness, and adherence of a company's quality system to the regulations.

In today's regulatory environment, it is important for organizations to know the regulations with the same depth of knowledge and understanding as regulators. If an organization happens to be a contract manufacturer, it might also find itself in the position of providing that in-depth regulatory expertise to customers. In either case, the contract manufacturer and its customers must be able to work with each other and within the regulatory requirements to assure that the product manufactured and released for patients is of the highest quality. The partnership between the contract provider and contract giver must reflect the requirements and time commitments as defined in the regulations.

Potential out-of-spec and adverse event reports

In situations where more than one organization is involved in the complaint and out-of-specification (OOS) processes for the product, all participating organizations must be harmonized in their approach for handling customer complaints and OOS results. In this author's opinion, it is the responsibility of the license holder (i.e., the NDA holder) to make sure its contract providers have the necessary processes and timelines in place to meet the necessary regulatory expectations. Likewise, it is up to the contract providers to make sure their internal systems meet regulatory expectations for all their clients.

These systems should have established, agreed-to turnaround times regardless of whether the organization manufactures its own products or contracts the manufacturing and testing to external organizations. Complications can arise when more than one organization is involved in the processes and timelines for handling complaints and OOS results.

The parties involved therefore must establish internal requirements that are consistent with the regulatory guidelines and give both parties sufficient time to conduct the needed activities required for the investigation into the complaint or OOS. The processes and timelines for handling complaints should be defined in a Quality Agreement and the related SOPs of the respective organizations and should include a clear delineation of which organization is responsible for various aspects related to the investigation.

Contract organizations should establish timeframes for completing certain investigation activities, which may vary from client to client, but are usually completed within 30 days. The internal SOPs for handling complaints should be robust enough to be able to handle various clients' needs without creating multiple SOPs on the same topic. The process for investigating and handling OOS results should be similarly defined.

The complaint SOP and the Quality Agreement also should address the turnaround requirements needed to investigate complaints associated with adverse or serious unexpected adverse events. For these complaints, the turnaround time must be able to accommodate tighter regulatory requirements. The license holder (i.e., the client) is required to submit a Field Alert within 3 working days after becoming aware of a reported problem either through a complaint or internal testing.

In these cases, the complaint must be investigated quickly by the contract manufacturer. The turnaround time for these types of investigations should be defined in the Quality Agreement and subsequent SOPs and must be more expeditious than the timelines for handling routine investigations. OOS reports also require an expedited timeline for communicating confirmed results to the client because of the potential impact to product already distributed for use.

In some cases, there may be more than two organizations involved in product manufacturing. These relationships can be complicated and communication lines blurred. The license holder must make sure through its various Quality Agreements that compliance to the regulations is met and responsibilities are clearly defined and adhered to.


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