What regulations must be strictly followed for pharmaceutical contract manufacturing?
Contract manufacturing of pharmaceutical products (commissioned production) must strictly comply with regulations such as the "Drug Administration Law," the "Measures for the Supervision and Administration of Pharmaceutical Production," and the "Pharmaceutical GMP." The core requirements revolve around qualification licensing, quality responsibility, production compliance, risk management, and prohibitive requirements. Both the commissioning party (the Marketing Authorization Holder, MAH) and the contract manufacturer must obtain pharmaceutical production licenses. The contract manufacturer must also receive GMP compliance certification for the corresponding dosage form. For certain products—such as traditional Chinese medicine injections—additional age-related requirements apply to the qualifications of personnel and production records of both parties. Prior to entrusting production, the MAH must assess the contract manufacturer's capabilities in quality and risk management, and sign a commissioning agreement and a quality agreement that conform to regulatory guidelines, clearly defining the responsibilities of each party at key stages. The MAH bears overall responsibility for the quality of the drug throughout its entire lifecycle, and the contract manufacturer is prohibited from sub-contracting the work to third parties. The production process must strictly adhere to the approved registration standards and manufacturing procedures, implement GMP-compliant full-process control, and ensure that records are authentic and traceable. Material suppliers shall be reviewed and managed by the Marketing Authorization Holder (MAH). Critical equipment must undergo validation and be revalidated periodically. Before products leave the factory, they must be reviewed and released by the Qualified Person for Quality Assurance. The manufacture of active pharmaceutical ingredients, pharmaceutical preparations containing controlled substances, and other such products is prohibited from being outsourced. Any change in the manufacturing enterprise requires approval from the provincial drug regulatory authority and completion of corresponding research and verification. Both parties must establish a quality system and a change-control mechanism, and subject themselves to comprehensive regulatory oversight by the drug regulatory authority throughout the entire supply chain, thereby ensuring the safety, quality, and compliance of pharmaceutical production.
Feb 25,2026
Contract manufacturing of pharmaceutical products (commissioned production) must strictly comply with regulations such as the "Drug Administration Law," the "Measures for the Supervision and Administration of Pharmaceutical Production," and the "Pharmaceutical GMP." The core requirements revolve around qualification licensing, quality responsibility, production compliance, risk management, and prohibitive requirements. Both the commissioning party (the Marketing Authorization Holder, MAH) and the contract manufacturer must obtain pharmaceutical production licenses. The contract manufacturer must also receive GMP compliance certification for the corresponding dosage form. For certain products—such as traditional Chinese medicine injections—additional age-related requirements apply to the qualifications of personnel and production records of both parties. Prior to entrusting production, the MAH must assess the contract manufacturer's capabilities in quality and risk management, and sign a commissioning agreement and a quality agreement that conform to regulatory guidelines, clearly defining the responsibilities of each party at key stages. The MAH bears overall responsibility for the quality of the drug throughout its entire lifecycle, and the contract manufacturer is prohibited from sub-contracting the work to third parties.
The production process must strictly adhere to the approved registration standards and manufacturing procedures, implement GMP-compliant full-process control, and ensure that records are authentic and traceable. Material suppliers shall be reviewed and managed by the Marketing Authorization Holder (MAH). Critical equipment must undergo validation and be revalidated periodically. Before products leave the factory, they must be reviewed and released by the Qualified Person for Quality Assurance. The manufacture of active pharmaceutical ingredients, pharmaceutical preparations containing controlled substances, and other such products is prohibited from being outsourced. Any change in the manufacturing enterprise requires approval from the provincial drug regulatory authority and completion of corresponding research and verification. Both parties must establish a quality system and a change-control mechanism, and subject themselves to comprehensive regulatory oversight by the drug regulatory authority throughout the entire supply chain, thereby ensuring the safety, quality, and compliance of pharmaceutical production.
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