23.06.2014 |

LOGFILE No. 27/2013 - Industry Perspective on Quality Agreements - GMP News

Quality Agreements: How to build a relationship? (Part II)

By Thomas Peither

Part II of this article covers the presentation that was held by Rebecca Devine, Ph.D, GMP Consultant, at the PDA/FDA Joint Regulatory Conference 2013 in Washington DC.

Rebecca Devine took a closer look at Quality Agreements from the industry´s point of view. Together with the FDA perspective featured in part I of this article we complete the 360° panoramic view on this important aspect related to outsourcing in the pharmaceutical industry.

Current Situation

The title of Rebecca Devine’s presentation was “Engaging Companies to Establish and Follow Quality Agreements“. The current situation is as follows:

  • Complex supply chain
  • Virtual company
  • Increased capacity
  • Specialized services
  • Capital/ongoing costs
  • Increased flexibility

Paula Katz, FDA, and Rebecca Devine agree on the regulatory requirements and references that were described in part I of this article.

Client-Contractor Relationship

It is of upmost importance to define the responsibilities and roles of each partner clearly. Rebecca Devine used synonyms for the client (owner, contract giver, applicant) and for the contract manufacturing organisation/CMO (contracted facility, contract acceptor).

In principle the responsibilities are:

Client

  • Responsible for the drug product quality
  • Exercises supervision and control
  • Meets regulatory expectations

CMO

  • Meets cGMPs
  • Performs services as contracted
  • Fulfills contract to the client and delivers services/goods

It is a long-term relationship between the client and the CMO and in the early stage of a relationship both parties must develop a common understanding of the outsourcing procedures. It is crucial that each party recognizes each other’s responsibilities and agrees on the communication that is needed in this collaboration.

A standard procedure should include a due diligence visit, definition of a communication process, development of a Quality Agreement, request for references, elaboration of a risk assessment, and a comprehensive quality assurance audit.

To reach a common understanding is crucial since the client and the CMO do not always share the same goals but may have different objectives:

Client

  • Market a safe and effective product
  • Make product cost effectively
  • Meet regulatory expectations

CMO

  • Provide compliant services for profit
  • Succeed in their sector/stay busy
  • Keep all customers happy

Because the goals may be different it is important that a Quality Agreement supports the understanding and communication. It should allow that various issues are being discussed and agreed upon ahead of time. The involvement of the Quality Units of both parties in the discussions is essential in all stages of an evolving relationship.

Establishing a Quality Agreement

Rebecca Devine detailed the difference between a Manufacturing Services Agreement (MSA) and a Quality Agreement. The MSA is the legal contract of the services and it includes juridical issues such as ownership of technology, terms, indemnity, pricing, deliverables, timelines and responsibilities. She also pointed out that Quality Agreements are routine for most of the CMOs. Usually the MSA references the Quality Agreement and defines the relationship between the Quality Agreement and the MSA. Most often the MSA is executed prior to the Quality Agreement.

The Quality Agreement has to be finalized prior to the start of services. Typical areas of negotiations between the two parties are:

Person in plant

  • Number of people
  • Areas of access
  • Time on-site

Annual audits

  • Length
  • Number of auditors
  • Response times to the audit observations

“For cause” audits

Lots release responsibilities

  • Review of batch records
  • Manner of supplying records to the client

Introduction of new products/changeover

Materials

  • Supplier
  • Vendors
  • Approval of specification

Inspections

  • Notification
  • Person on-site for inspection
  • Review of responses to inspections

Content of a Quality Agreement

The table of content for a Quality Agreement could look like the following blue print:

  • Background/Scope/Purpose
  • Key contacts
  • Definitions
  • Locations for services
  • Activities at each location
  • Products and cross contamination (notification)
  • Subcontracting
  • Regulatory inspections
  • GMP compliance expectations
  • Quality Unit responsibilities
  • Responsibilities of each party (tables, narrative or lists, follows the process and GMPs)
  • Facilities and equipment
  • Controlled documentation (SOPs, batch records, protocols)
  • Change Control
  • Deviations and OOS
  • Complaints
  • Recalls
  • Adverse reaction reports
  • Records and retention
  • Information for regulatory filings

Following the Quality Agreement

To set up a proper Quality Agreement is one thing; the more challenging step is to follow the agreed provisions.

It goes without saying that it is critical to assure each party follows the Quality Agreement. Furthermore the following points are essential for a vital relationship between client and CMO:

  • Communication
  • Maintenance of team relationship
  • Routine team communication (weekly/bi-weekly)
  • Tracking of activities and action items
  • Person in plant activities
  • Change of agreement if necessary

Rebecca Devine stressed the aspect of communication which is, according to her experience, a key factor for a successful relationship.

She also highlighted the significance of the way of problem-solving especially for identified deviations and out of specification (OOS) situations.

In the case of deviations it is important to have a common understanding of the reporting procedures and to assure a team approach in solving deviations. The person in plant should help with his awareness. In deviations with critical impact the client should be involved in the review process of related deviations.

OOS situations should also be clarified in a Quality Agreement:

  • Reporting timeframes
  • Involvement in review and investigations
  • Retesting plans

Another focus of the presentation was on the change control system because a change:

  • Can impact regulatory filings,
  • May have unknown impact on client products,
  • Concerns the balance between too much and not enough involvement of the client, and
  • may impact multiple clients.

The possible impact on multiple clients makes the change management more complicated. In these cases it is crucial to communicate early to prevent delays.
 

Summary

Rebecca Devine recapped the main points of her presentation:

  • Quality Agreements are important components of the Client – CMO relationship
  • Fulfill the regulatory expectations
  • Keep in mind that communication is most important
  • Quality Agreements should assure that expectations between Client and CMP are clear
  • Team approaches are the best way for Client-CMO relationship
  • Client and CMO must be committed to honouring the Quality Agreement

The two presentations of Paula Katz and Rebecca Devine were followed by a final discussion. Both speakers stressed the fact that communication is the key between Client and CMO.

Having a background as a consultant for the pharmaceutical industry for more than two decades I can only back up the demand for communication. I would like to conclude this article by quoting the American author Tony Robbins:

„To effectively communicate, we must realize that we are all different in the way we perceive the world and use this understanding as a guide to our communication with others.“

Author:

Thomas Peither
Maas & Peither AG - GMP Publishing;
Maas & Peither America, Inc.;
Peither & Consultants GmbH

Icon LOGFILE-27-2013-Quality-Agreements-PartII-TP.pdf

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