How to manage each material in a pharmaceutical factory?

Materials must be accepted by batch or lot. Acceptance of raw and auxiliary key points: raw and auxiliary materials and delivery vouchers (single) and ordering contracts are consistent with the ticket, things match. The supply unit is the quality control department listed in the "material supplier list" in the unit. The packaging is not damaged, moisture, water, mold, rodent bites, insect traces. Solid raw materials must be double-packed, tightly sealed. Each package should be affixed (labeled) obvious signs, indicating the name, batch number, specifications, quantity, manufacturer, trademarks, etc., and accompanied by a certificate of conformity. Liquid raw materials containers are tightly sealed, no signs of opening, no oozing or leaking, labeled or marked with a distinctive sign, indicating the name, batch number, specifications, quantities, manufacturers, trademarks and certificates of conformity of the product. Poison, hemp, essence and precious drug raw materials should be two-person piece-by-piece acceptance. Acceptance of Chinese herbal medicines requires that the means of transportation of Chinese herbal medicines should be closed trucks or trucks that cover the herbs tightly with thatching cloth. Chinese herbal medicines must be packaged, and bamboo wattles, straw mat bags and bags made of toxic materials cannot be used. Each package must be clearly marked with the name, quantity, specification, source, origin and harvest (processing) date. Name, quantity, specifications, origin and source must be consistent with the delivery voucher and ordering contract. Supply unit is listed in the quality management department "material for the list of households" in the unit. Receiving and inspection of the whole batch of herbs should be authenticity, quality and quality checks, check the water content, there is no adulteration, there is no mold, insect moths, oil deterioration, odor, insects, insect eggs and insect carcasses and so on. If necessary, the quality management department of the Chinese medicine inspector to participate in the acceptance. The precious Chinese herbal medicines must be inspected and accepted piece by piece by two persons. The outer packaging of herbs should be free of damage, moisture, water damage, mold, insect, rodent bites, etc.. Chinese herbal medicines or tablets that are not pre-treated and directly used for production need to be double-packed, and the inner and outer packages should be sealed without breakage or leakage. Fresh herbs should be bright in color, no peculiar smell, no dryness and within the stipulated freshness period. Its transportation should adopt the means of transportation with low-temperature facilities. Hemp, poisonous, flammable and explosive herbs should be double piece-by-piece acceptance; packaging should be marked with obvious provisions respectively. (3) acceptance of packaging materials Packaging materials should be consistent with the delivery voucher, ordering contract, tickets, things match. ② manufacturer must be listed in the quality control department, "material supply list, the unit. ③ All packaging materials must have external packaging, external packaging can not use bamboo, straw bags and toxic materials made of bags. Direct contact with the product packaging materials must be double packaging, each layer of packaging should be sealed tightly, no damage. ④The outer package of packaging materials should be free of damage, moisture, water, mold, insect and rodent bites. ⑤ The outer packaging should be labeled with the contents of the name, specifications, quantity, manufacturer and product certification. ⑥ Cartons, sealing stickers and other printed materials should also be checked for the material, size, text content, folding, cutting, printing quality and so on. (7) the development of acceptance criteria, you can refer to 7 - Attachment III "packaging material defects in the classification and acceptable limits table. (4) acceptance of the number of samples: ① raw materials, excipients, according to the "Chinese Pharmacopoeia" of the relevant provisions. ② packaging materials can be in accordance with the relevant provisions of GB 2828. (5) If the acceptance inspection found that any of the acceptance content does not meet the requirements, the inspector should make a decision to reject, fill out the "Rejection Record", and notify the quality control officer and the buyer. 3, the material into the factory coding (1) the principle of the material into the factory coding into the factory code should be expressed in the time of the material into the factory, the number of times, each batch of a code. The code should indicate the category of materials into the factory. The code should be able to indicate the best form of the material itself. According to the code can control the first-in-first-out. Examples of coding format 1. warehousing conditions and management of a warehouse classification and scope of application 1. temperature classification of warehouses according to temperature classification table Table 7-2 name temperature ℃ relative humidity % of the scope of application of the example of cold storage 2-1060-75 live and fresh herbs, animal organs, strains, biological products. Cool storage 10-2060-75 precious fine herbs, high sugar-containing herbs, cephalosporin raw materials, hollow capsules and other materials with temperature and humidity requirements. Ordinary library 0-3060-75 no special storage temperature requirements of the material.　2. Classification by nature of the nature of the material warehouse classification table 7-3 name of the scope of application of examples of raw materials library chemical raw materials, excipients, Chinese herbal medicines. Net material library concocted, sorted and processed net herbs. Package materials warehouse direct contact with drug packaging materials, containers, paper products, etc.. Flammable and explosive library flammable and explosive raw materials, herbs, excipients, solvents, reagents, gasoline and so on.　Precious fine library of precious herbs, valuable raw materials. Special library toxic library toxic herbs, anesthesia herbs, anesthesia raw materials, Ⅰ, Ⅱ types of psychotropic raw materials, medical toxicity raw materials. Or special label library labels, printed with the same content as the label of the drug packaging, instructions for use; product certification, anti-counterfeiting signs. Cabinet pollution library (separate libraries) talcum powder, activated carbon, honey, grease, volatile odor raw materials.　Sensitization library of raw materials for highly toxic drugs.　Strain library of biological products with bacteria and poisonous species.　Inside the package material area directly to the corner of the drug packaging materials, containers, outside the package material area outside the packaging materials. 3. Warehouse partitioning materials warehouse should be divided into packaging cleaning place, receiving area, to be inspected area, qualified area, substandard products area, return area, preparation area (or issue area), office and so on. Warehouse should be equipped with a sampling room, the air cleanliness level and production requirements. Solid materials and liquid materials should be stored separately. Second, set up and stacking requirements 1. Each warehouse should be equipped with set up a map, marked warehouse area, storage category, cargo space row number, etc., at the same time should be based on the nature of the material and packaging regulations stacking, quantity. 2. Material should be placed on the pallet, should not be in direct contact with the ground, the pallet should be kept clean, the bottom of the ventilation and moisture. 3. Sporadic materials should be stored on the shelf, neatly arranged, not inverted. 4. According to the varieties, Specification, batch number stacking materials, materials placed firmly, neatly, no obvious tilt, should be in line with the distance regulations. Distance requirements are: (1) the distance between the stack and the stack of not less than 100cm; (2) the distance between the stack and the wall is not less than 50cm; (3) the distance between the stack and the beam is not less than 30cm; (4) the distance between the stack and the column is not less than 30cm; (5) the distance between the stack and the ground is not less than 10cm; (6) the width of the main access road is not less than 200cm; (7) the lighting fixtures are not allowed to stack the materials below the vertical ; the vertical distance between the vertical bottom and the level of the stack of materials is not less than 50cm; 5. A variety of equipment in the library, facilities, appliances, tools, cleaning tools, etc. should be placed in accordance with the location of the prescribed positioning map neatly, marked clearly. Third, the state of the sign of a variety of materials in the warehouse should be obvious state signs and cargo position card. Measuring instruments status signs. Warehouse of all measuring instruments should be affixed with measurement verification "certificate of conformity", and marked the effective date. 3 material status signs (1) to be tested material signs: yellow, which is printed with the word "to be tested". (2) test qualified material signs: green, which is printed with the word "qualified". (3) failed material signs: red, which is printed with the word "failed". (4) to be destroyed material signs: blue (or other colors other than yellow-green), which is printed with the word "destroy". (5) sampling samples sign: white, which is printed with the words "sampling certificate. (6) Replacement of packaging signs: white, which is printed with the words "change packaging. Fourth, maintenance 1. temperature, humidity (1) regulating temperature and humidity facilities: cold storage: refrigeration units or refrigerators, freezers. Cool storage: refrigeration unit or air-conditioning units, air-conditioning cabinets. Ordinary library: exhaust facilities, dehumidifier. (2) Temperature and humidity monitoring and regulation measures are recorded twice a day. Cold storage mainly rely on refrigeration facilities to control the temperature and humidity on and off. Cool storage mainly relies on regulating refrigeration facilities or air-conditioning facilities to open and close to regulate temperature and humidity. Ordinary library through the switch windows, open exhaust fans, open dehumidifier, mopping and other measures to regulate humidity. 2. "Five prevention" (1) the warehouse door should be set up to prevent insect lamps; (2) windows, exhaust fans should be installed iron mesh, to prevent small animals climb (fly) into the warehouse. (3) The warehouse should be set up electronic cats, rat glue, rat cages and other anti-rodent measures. (4) Warehouse should be set up fire, theft, flood prevention facilities, it is appropriate to use explosion-proof lamps. 3 inspection and re-inspection (1) according to the nature of the material, characteristics and storage conditions, the material in the warehouse on a daily basis and regular inspection and maintenance; the implementation of the "prevention-oriented" principle. Chinese herbal medicines can refer to the "safe moisture range of Chinese herbal medicines storage" to control the moisture of the stock of Chinese herbal medicines. (See 7-Attachment II). (2) In general, inspect and record the materials once a quarter, apply for re-inspection of materials with signs of deterioration and take conservation measures. (3) For the precious Chinese herbal medicines, valuable raw materials, easy to deteriorate, unstable, close to the expiration date, there are signs of deterioration of the material to strengthen the inspection, such as: weekly inspection and record, found that the problem is dealt with in a timely manner. (4) The materials are stored according to the specified period of use, and the materials without specified period of use shall be stored for not more than three years. To the period of one month before the material should apply for re-inspection; re-inspection in line with the provisions of the continued use; does not meet the requirements, it should be scrapped and destroyed. 4. Pest control of Chinese herbal medicine. (1) Chinese herbal medicine maintenance room should be set up. (2) cargo pile around or adjacent to the Chinese herbal medicines found to have worm threads, moth powder of Chinese herbal medicines should be implemented pest control measures; usually should also be regularly on the Chinese herbal medicines to prevent and control pests in the maintenance. (3) Toxic gas fumigation method. Commonly used aluminum phosphide, 9 to 18 grams per cubic meter of herbs. Place in the herbal conservation room, fumigate the herbs at a temperature of more than 20 ℃ for 96 hours, and then ventilation, exhaust gas, time 3-5 days.