US Food and Drug Administration (FDA) is planning to issue the Guidance for contract manufacturing arrangements for drugs in a few weeks from now. The new norms will be known as the Quality Agreements.
The regulatory authority which issued draft of the guideline in May this year has now received the feedback from the contract manufacturing industry. The final guidance which is expected in a few weeks would highlight how pharma industry involved in the contract manufacturing of drugs can utilize quality agreements to delineate their responsibilities and assure drug safety and efficacy.
The guidance applies to the commercial manufacturing of Active Pharmaceutical Ingredients (APIs), intermediates, finished drug products, combination products, and biological drugs.
All contracted facilities must assure compliance with applicable Current Good Manufacturing Practices (CGMP) for all manufacturing, testing or other support operations performed to make a drugs for the owner. The guidance describes how contract manufacturing operations fit within the larger scheme of pharmaceutical quality systems and presents the Agency’s current thinking on the roles and responsibilities of entities involved in contract manufacturing arrangements, stated the regulatory authority.
The key objective of the guideline is to establish responsibilities of the contract manufacturing for which US FDA has put in place a statutory and regulatory framework.
“With respect to contract manufacturing, both owners and contracted facilities must also work together to establish and maintain quality oversight of contracted manufacturing operations and the materials produced under contracted manufacturing arrangements,” said the guidance.
Various US FDA guidance documents indicate how quality management principles relate to contract manufacturing operations. It has highlighted some of the responsibilities of product owners and contracted facilities. For instance the ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (ICH Q7) recommends that manufacturers evaluate contractors for CGMP compliance. Product owners could hire another party to perform the operational processes that are part of a manufacturer’s inherent responsibilities.
The ICH guidance for industry Q9 Quality Risk Management (ICH Q9) recommends a comprehensive evaluation of suppliers and contract manufacturers through auditing and implementing supplier quality agreements.
Finally, the ICH guidance for industry Q10 Pharmaceutical Quality Systems (ICH Q10) states that the control and review of any outsourced activities is ultimately the responsibility of the pharmaceutical company.
FDA’s guidance for industry Cooperative Manufacturing Arrangements for Licensed Biologics provides additional information regarding the responsibilities of licensed biological product manufacturers and those of contract manufacturers.
Before outsourcing manufacturing activities, the owner should conduct a risk review that evaluates the extent of controls required for the particular supplier and the particular product or service covered by the agreement. Based on this risk, the manufacturer needs to assess the suitability of the potential contracted facility to carry out the audits, material evaluations.
The contracted facilities should define the responsibilities and communication processes for quality-related activities of the involved parties. It should document these in a written agreement between the owner and contracted facility. They should monitor the performance of the contracted facility and identify and implement any required improvements.
The company engaged in performing manufacturing operations should monitor incoming ingredients and materials to ensure they are from approved sources using the agreed supply chain.
The regulator FDA expects the companies engaged in contract manufacturing operations to implement quality management practices.