How to manage the materials in pharmaceutical factory?

Materials must be accepted in batches or batches. Key points for acceptance of raw and auxiliary materials: raw and auxiliary materials are consistent with the factory certificate (single) and the order contract, and the tickets and goods are consistent. Suppliers are companies in the "Material Suppliers List" listed by the Quality Control Department. The outer packaging is free from damage, moisture, water stains, mildew, rat bites and moth-eaten. Solid raw and auxiliary materials must be packed in double layers and sealed tightly. Each package should be clearly marked with product name, batch number, specification, quantity, manufacturer, trademark, etc. , with a product certificate. The containers of liquid raw and auxiliary materials are tightly sealed, and there are no signs of unsealing, exudation or leakage, and there are obvious signs indicating the product name, batch number, specification, quantity, manufacturer, trademark and product certificate. Poison, hemp, essence and precious pharmaceutical raw materials should be checked and accepted by two people one by one. The acceptance of Chinese herbal medicines requires that the means of transport of Chinese herbal medicines should be closed trucks or trucks tightly covered with tarpaulins. Chinese herbal medicines must be packaged, and bamboo baskets, straw mats and packaging bags made of toxic materials cannot be used. Each package must be clearly marked with name, quantity, specification, source, place of origin and date of collection (processing). The name, quantity, specification, origin and source must be consistent with the delivery certificate and the order contract. Suppliers are companies in the "Material Suppliers List" listed by the Quality Management Department. Inspectors should check the authenticity, advantages and disadvantages of the whole batch of medicinal materials, and check the water content, whether there is doping, mildew, moth-eaten, oily deterioration, odor, moth-eaten, eggs and insect carcasses. When necessary, Chinese medicine inspectors from the quality management department will participate in the acceptance. Your superior Chinese herbal medicines must be accepted by two people one by one. The outer packaging of medicinal materials should be free from damage, moisture, water stains, mildew, moth-eaten, rat bites, etc. Traditional Chinese medicine or decoction pieces directly used for production without pretreatment need to be packed in double layers, and the internal and external packaging should be sealed, so as not to be damaged or leaked. Fresh medicinal materials should be bright in color, free from peculiar smell and dryness, and within the specified storage period. Its transportation should adopt the means of transportation with low-temperature facilities. Hemp, toxic, flammable and explosive medicinal materials should be accepted by two people one by one; The package shall be clearly marked. (3) Key points for acceptance of packaging materials The packaging materials shall be consistent with the delivery certificate and the order contract, and the tickets and goods shall be consistent. (2) The manufacturer must be the unit listed in the Material Supplier List of the Quality Control Department. ③ All packaging materials must have outer packaging, and bamboo baskets, straw mats and bags made of toxic materials cannot be used as outer packaging. The packaging materials in direct contact with products must be packed in double layers, and each layer of packaging should be tightly sealed and intact. ④ The outer packaging of packaging materials should be free from damage, moisture, water stains, mildew, moth-eaten and rat bites. ⑤ The name, specification, quantity, manufacturer and product certificate of the contents shall be marked on the outer package. ⑥ Check the materials, dimensions, text content, folding, cutting and printing quality of printed matter such as cartons and sealed labels. ⑦ Please refer to 7- Appendix 3 "Packaging Material Defect Classification and Acceptable Limit Table" when formulating the acceptance standard. (4) Acceptance sampling quantity: ① Raw and auxiliary materials meet the relevant provisions of China Pharmacopoeia. ② The packaging materials can meet the relevant regulations in GB 2828. (5) If any acceptance content is found not to meet the requirements during acceptance, the inspector shall make a rejection decision, fill in the rejection record and notify the quality controller and the buyer. 3. Material incoming code (1) Material incoming code principle The incoming code should indicate the time and quantity of materials entering the factory, with one code for each batch. The code should indicate the type of incoming materials. The code should best represent the shape of the material itself. According to the code, FIFO can be controlled. Examples of encoding formats are 1. Storage conditions and management 1. Classification and scope of application of warehouses 1. Classification of warehouses by temperature Table 7-2 Application scope of temperature℃ and relative humidity% Take cold storage 2- 1060-75 fresh medicinal materials, animal organs, strains and biological products as examples. Cold storage 10-2060-75 Precious and fine medicinal materials, high-sugar medicinal materials, cephalosporins, hollow capsules and other materials with temperature and humidity requirements. General warehouse 0-3060-75 has no special requirements for storage temperature. 2. Classification of material warehouses by nature Table 7-3 Name of raw material warehouse Scope of application Examples of chemical raw materials, auxiliary materials and Chinese herbal medicines. Pure medicinal materials processed and sorted in the pure material warehouse. Packaging materials warehouse is in direct contact with pharmaceutical packaging materials, containers, paper products, etc. Flammable and explosive materials, medicinal materials, auxiliary materials, solvents, reagents, gasoline, etc. Precious herbs and raw materials are stored in your warehouse. We specialize in storing toxic medicinal materials, narcotic drugs, raw materials for narcotic drugs, raw materials for psychotropic drugs of Category I and II, and raw materials for toxic drugs for medical use. Or special label library labels, drug packages and instructions printed with the same contents as the labels; Product certificate, anti-counterfeiting mark, etc. Contaminated warehouses (separate warehouses) include talcum powder, activated carbon, honey, grease, volatile odor raw materials, etc. Sensitization library high-risk drugs raw materials. Strains used in biological products in bacterial libraries. The packaging materials, containers and outer packaging materials in the inner packaging material area are directly connected with the horn powder. 3. Warehouse partition Material warehouses should be divided into outer packaging cleaning places, receiving areas, areas to be inspected, qualified areas, unqualified products areas, return areas, material preparation areas (or distribution areas), offices, etc. The warehouse should be equipped with a sampling room, and its air cleanliness level is consistent with the production requirements. Solid materials and liquid materials should be stored separately. 2. Installation and stacking requirements: 1. Each warehouse shall provide an installation drawing, indicating warehouse area, storage category, location and quantity of goods, etc. At the same time, the stacking method and quantity should be specified according to the nature and packaging conditions of each material. 2. Materials should be supported by pallets, which should not directly touch the ground. The tray should be kept clean and the bottom should be ventilated and moisture-proof. 3. Sporadic materials should be stored on the shelves, neatly placed and not upside down. 4. Stack materials according to varieties, specifications and batch numbers. Material packaging should be firm and tidy, without obvious inclination, and conform to the distance regulations. The required distance is: (1) The distance between stacks is not less than100 cm; (2) The distance between the crib and the wall is not less than 50 cm; (3) The spacing between the crib and the beam shall not be less than 30cm; (4) The spacing between piles and columns shall not be less than 30cm; (5) The spacing between the crib and the ground shall not be less than10cm; (6) The width of the main channel is not less than 200 cm; (7) No vertical stacking of materials is allowed under the lighting lamp; The horizontal distance between the vertical lower part and the material pile is not less than 50 cm; 5. All kinds of equipment, facilities, appliances, tools, cleaning tools, etc. In the warehouse, it should be placed neatly according to the position specified in the fixed drawings, and clearly marked. Three. Status tag All inventory materials should have obvious status tags and location cards. Status marks of measuring instruments. All measuring instruments in the warehouse shall be affixed with metrological verification certificates, and the effective date shall be marked. 3 Material status mark (1) Material to be inspected mark: yellow with the words "to be inspected" printed on it. (2) Inspection qualified material mark: green, with the word "qualified" printed on it. (3) Unqualified material sign: red with the word "Unqualified" printed on it. (4) Marking of materials to be destroyed: blue (or other colors other than yellow and green) printed with the words "destroyed". (5) Sampling mark: white with the words "sampling certificate" printed on it. (6) Packaging change sign: white, with the words "packaging change" printed on it. Fourth, repair 1. Temperature and humidity (1) Temperature and humidity adjustment facilities: cold storage: refrigeration unit or refrigerator or freezer. Cold storage: refrigeration unit or air conditioner, air conditioner cabinet. General warehouse: exhaust facilities, dehumidifier. (2) Temperature and humidity monitoring and adjustment measures record the temperature and humidity of the warehouse twice a day. Cold storage mainly depends on the start and stop of refrigeration facilities to control temperature and humidity. The cold storage mainly depends on adjusting the start and stop of refrigeration facilities or air conditioning facilities to adjust the temperature and humidity. Ordinary warehouses adjust humidity by opening and closing windows, turning on exhaust fans, turning on dehumidifiers, mopping the floor and other measures. 2. "Five Prevention" (1) insect-proof lights should be installed at the door of the warehouse; (2) Windows and exhaust fans should be equipped with iron nets to prevent small animals from crawling (flying) into the warehouse. (3) The warehouse should be equipped with anti-rat measures such as electronic cat, anti-rat glue and anti-rat cage. (4) The warehouse shall be equipped with fire prevention, anti-theft and waterproof facilities, and explosion-proof lamps shall be used. 3. Inspection and reinspection (1) According to the nature, characteristics and storage conditions of materials, the materials in the warehouse are inspected and maintained on a daily and regular basis; Implement the principle of "prevention first". Chinese herbal medicines can refer to the Safe Moisture Range of Chinese Herbal Medicine Storage to control the moisture of Chinese herbal medicines in stock. (See 7- Appendix 2). (2) Generally, materials shall be inspected once every quarter and recorded. Materials with signs of deterioration shall apply for re-inspection and take maintenance measures. (3) Strengthen the inspection of precious Chinese medicinal materials, precious raw materials, materials that are perishable, unstable, approaching the shelf life and showing signs of deterioration, for example, check once a week and record them, and handle problems in time when found. (4) Materials shall be stored within the specified service life, and materials without specified service life shall be stored for no more than three years. The materials shall be re-examined one month before the deadline; The reinspection meets the requirements before use; Those that do not meet the requirements shall be scrapped and destroyed. 4. Chinese herbal medicine pest control. (1) A Chinese herbal medicine curing room should be set up. (2) Insect control measures should be taken for Chinese herbal medicines with insect filaments and insect-eaten powder found around or near the cargo pile; Usually, Chinese herbal medicines should also be maintained regularly to prevent and control pests and diseases. ③ Poisonous gas fumigation. Commonly used aluminum phosphide, 9 ~18g per cubic meter. Put into a traditional Chinese medicine curing room, fumigating at a temperature above 20 DEG C for 96 hours, and then ventilating and detoxifying for 3-5 days.