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What regulations must be strictly followed for pharmaceutical contract manufacturing?

2026-02-25

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.

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Why is capsule production so strict?

2026-02-25

Why is capsule production so strict?

The entire capsule production process is strictly controlled, with the core focus on ensuring medication safety, preventing cross-contamination, and complying with regulatory standards, which directly affects patients' lives and health. Capsules are mostly oral medications that enter the human digestive system directly. If the production environment is unclean or the raw materials are substandard, it can easily cause allergies, infections, or even more serious health risks. Hollow capsules themselves are made from gelatin, plant fibers, and other materials, which are prone to absorbing moisture, deteriorating, and breeding microorganisms. They must be produced in temperature- and humidity-controlled cleanrooms of at least Class 100,000, with strict control over bacteria, mold, and heavy metal content. Drug production follows GMP standards. From raw material acceptance, gel preparation, dipping, drying, de-shelling, cutting, to fitting, every step has precise parameters and full records. Personnel, equipment, materials, and packaging must be managed in separate zones to prevent cross-contamination between different drugs and batches and to avoid mix-ups. Additionally, capsules must meet stringent quality indicators such as weight variation, disintegration time, and sealing integrity and undergo multiple inspections before leaving the factory. Regulatory authorities routinely conduct spot checks and on-site inspections of pharmaceutical companies, and violations can result in production stoppages, license revocation, and other severe penalties. Strict production is not an extra requirement but the baseline standard of the pharmaceutical industry. Only through standardized and regulated processes can the safety, efficacy, and stability of every capsule be ensured.

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