1. The purpose and significance of formulating this method
Pharmaceutical packaging is directly related to the quality of medicines and the convenience of patients' safe medication. If the quality of the packaging personnel, the building structure of the packaging plant, the selection of packaging materials and containers do not meet the requirements, the qualified drugs produced may be mixed and contaminated during packaging, and problems may also occur during the storage and transportation of the drugs. This affects the internal quality of drugs and patient medication. Therefore, the packaging of medicines is a very important issue. In response, the State Administration of Medicine issued the "Administrative Measures for Drug Packaging" on February 12, 1988, which put forward standardized requirements for drug packaging, aimed at strengthening drug packaging management and ensuring drug quality. This management method requires that drug management, scientific research, production, and business units and enterprises that produce pharmaceutical packaging materials and containers must all comply.
2. Main content
These measures are divided into general provisions, basic packaging requirements, staff, packaging workshops, packaging materials, supervision, inspection, handling and supplementary provisions, totaling forty-four articles. The main contents are:
1. Basic packaging requirements
This approach puts forward five basic requirements for drug packaging.
①The packaging of medicines must meet the requirements of national and professional standards. If there is no such standard, the enterprise shall formulate the drug packaging standard and implement it after approval by the provincial medical management department and the Bureau of Standards. Drugs without packaging standards shall not be shipped or sold.
② Before applying for new drug appraisal and new product approval, drug manufacturers must submit relevant test data and test method reports of the packaging materials used in the container to the local provincial medical management department, together with packaging quality standards, and then apply for appraisal after approval .
③Medicinal packaging materials and containers must comply with national standards, professional standards, or local and corporate standards. Enterprises that produce packaging material containers that directly contact drugs must obtain a "Medicinal Packaging Material Container Production License" issued by the State Medical Administration.
④The medicine packaging must be sealed, sealed, sealed, or use anti-theft caps, bottle cap sleeves, etc. The label must be affixed and adhered firmly, and must not be put into the bottle with the medicine.
⑤The transportation packaging of medicines must meet national or professional standards, and the transportation packaging of various medicines must meet the requirements of their physical and chemical properties. The storage and transportation pictorial signs of drug transport packaging, and the packaging signs of dangerous goods, etc., must comply with national standards and relevant regulations.
Packaging management personnel are required to have a technical secondary school or high school education level, and have professional training to have pharmaceutical packaging technology and management knowledge. Packaging operators must be familiar with the operating procedures and responsibilities of this post. Packing staff should be trained regularly to explain drug packaging regulations, standards, packaging technology and other knowledge, and regular health checks should be conducted.
3. Packaging workshop
The process layout of the packaging plant must prevent the mixing and pollution of medicines. The building and structural design must prevent insects from entering, and the indoor surface is smooth and seamless. The packaging area where the medicine is directly exposed to the air must meet the requirements of the relevant cleanliness regulations.
4. Packaging materials
This approach puts forward five requirements for packaging materials.
① The packaging materials and containers that directly contact the drugs must be non-toxic, have no chemical interaction with the drugs, and their components will not fall off or migrate into the drugs. They are not allowed to be reused (except the turnover packaging containers for antibiotic raw materials), and are not allowed to be used Straw bags, sacks, and willow baskets that pollute products and pharmaceutical factory hygiene. The packaging materials for medicines should meet the sanitary requirements.
②The label shall be picked up by a special person from the workshop, and the quota shall be issued and recorded. Labels cannot be transferred, sold or circulated in any form.
③ The decoration design of labels, instructions, boxes, bags, etc., should reflect the characteristics of the drug, product name, text, pattern, color and other designs that meet the requirements, and imitation or plagiarism is strictly prohibited.
④Specially managed drugs and external drugs must be marked with the required signs on their labels, instructions, bottles, boxes, boxes and other packaging materials. The registered trademark or registration mark shall be printed on the prominent position of the drug packaging container or label.
⑤The text content of general drug label, drug repackaging label and API label must be written in all items as required.
5. Supervision, inspection, punishment
These measures are supervised, inspected and punished by the local medical management departments at or above the county level or the departments designated by the people's government. Violation of the provisions of these Measures, depending on different circumstances, may be ordered to rectify within a time limit, stop production or change production, confiscate the illegal income of the year, order the manufacturer to take back the products that have been delivered, warn the violation unit, and impose a certain amount of fines on the directly responsible person.