The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Guidelines for Quality Agreement on Drug Consignment Production (Draft for Comments)”

1. Purpose and Scope

This guideline is formulated to regulate drug entrusted production, ensure drug quality and safety, guide and supervise drug marketing authorization holders (hereinafter referred to as "holders") and entrusted drug manufacturers (hereinafter referred to as "trustees") to fulfill drug quality assurance obligations, implement drug management laws and regulations and drug production quality management specifications through signing entrusted production quality agreements, and ensure that the entire drug production process continues to meet legal requirements.

This guideline is for reference when holders and trustees sign entrusted production quality agreements.

2. Legal basis

"Drug Administration Law of the People's Republic of China"

"Vaccine Administration Law of the People's Republic of China"

"Regulations for the Implementation of the Drug Administration Law of the People's Republic of China"

"Drug Registration Management Measures"

"Drug Production Supervision and Management Measures"

"Drug Production Quality Management Standards"

3. Work requirements

(I) Basic requirements

Both parties to the quality agreement shall comply with the requirements of drug management laws and regulations and technical specifications, perform the relevant rights and obligations stipulated in the "Drug Production Quality Management Standards" and the various provisions of the quality agreement, and each shall bear the corresponding responsibilities in accordance with the law.

The quality agreement should specify in detail the GMP responsibilities of the holder and the trustee, and stipulate that the holder is responsible for the quality of the drug, and is legally responsible for the safety, effectiveness, and quality controllability of the drug throughout the production process.

Both parties must establish an effective communication mechanism, determine the direct contact person for technical quality in the quality agreement, and communicate in a timely manner on problems encountered during the implementation of the quality agreement. When disputes arise in change control, deviation, over-standard, quality complaints, and acceptance of supervision and management by drug regulatory authorities, the two parties should communicate and coordinate in a timely manner to ensure that they are properly resolved within the scope of legality and regulations and controllable risks. Any oral and written opinions reached during the communication and coordination process should be kept in the form of meeting minutes or memoranda.

The drafting of the quality agreement should be jointly participated by the quality management departments and relevant departments of the holder and the trustee, and its technical terms should be drafted by supervisors with pharmaceutical technology, inspection expertise, and familiarity with GMP.

The quality agreement should take effect after being signed by the legal representative, principal person in charge, or the quality person in charge or the quality authorized person entrusted by the holder and the trustee, on the premise of mutual agreement.

(II) Requirements of the holder

The holder shall be responsible for the safety, effectiveness and quality controllability of the drug throughout the entire process of drug development, production, operation and use in accordance with the law, and shall not entrust the entrusted production enterprise to bear the obligations and responsibilities that the holder is legally required to perform through the quality agreement.

Before signing the quality agreement, the holder shall examine the production conditions, technical level and quality management of the entrusted party, provide the entrusted party with the technical and quality documents of the entrusted production drugs, and confirm whether the entrusted party has the conditions and capabilities for entrusted production and whether it continues to comply with the requirements of GMP and the production quality management of entrusted production products.

During the entrusted production period, the holder shall guide and supervise the entire process of entrusted production and be responsible for the marketing release of entrusted production drugs. Conduct retrospective audits of the entrusted party regularly, and send personnel to supervise and manage the production process throughout the entrusted production process.

(III) Requirements of the entrusted party

The entrusted party shall strictly implement the quality agreement, effectively control the production process, and ensure that the entrusted production drugs and their production meet the requirements of registration and the "Good Manufacturing Practice for Pharmaceuticals". The quality standards of entrusted production drugs shall comply with national drug standards. The drug name, dosage form, specification, prescription, production process, source of raw materials, packaging materials and containers directly in contact with drugs, packaging specifications, labels, instructions, approval number, etc. shall be the same as the contents of the drug approval certificate held by the holder.

The entrusted party shall actively cooperate with the holder to accept the audit, and take corrective and preventive measures to actively implement rectification according to all defects found in the audit.

Specific news link: The General Department of the State Drug Administration publicly solicits opinions on the "Guidelines for Quality Agreements for Drug Manufacturing Contracts (Draft for Comments)"