What does QA do?

1. Material sampling: sampling of raw materials, auxiliary materials, packaging materials (inside and outside) and purified water. When sampling materials, the number of sampling units shall conform to the sampling rules, and the sampling certificate shall be affixed. \x0d\ 2。 Save samples of materials, raw materials and auxiliary materials; Finished product samples (domestic sales, foreign trade, Haizheng); Management of sample storage room; Observation records of domestic and Haizheng product samples (routine and key); Send samples of key reserve products and stability test products. \x0d\ 3。 Production and material monitoring: ① capsule workshop monitoring, status identification of each process, equipment production and cleaning. Whether the production records are filled in timely and accurately. \x0d\ ② Quality monitoring of raw and auxiliary materials and inner packaging materials: inspection when materials are put into storage: whether they are purchased from qualified suppliers, whether the packaging is complete and pollution-free, whether the label content is accurate and complete (see No.24 requirement), and whether there is a certificate of conformity in the barrel; Place the mousetrap and turn on the insecticidal lamp; Whether the whole warehouse environment is clean, dry and sanitary; Whether the materials are neatly stacked and stored in different regions; Whether penicillins and cephalosporins are stored in special areas; Whether the materials are placed according to the batch code; Whether the material status (to be inspected, qualified and unqualified) is accurate; Whether there is effective separation between batches; Whether the materials are stored according to the storage conditions (cold place, cool place); Whether the positioning card and temperature and humidity records are timely, accurate and complete; Whether special drugs (caffeine) are locked by two people and managed in time; Whether the packaging materials printed with contents are locked; \x0d\ ③ Quality monitoring of outer packaging process: whether the loading quantity is accurate, whether the aluminum-plastic plate is vacuumized or damaged; Whether the tablet is complete, whether there are black spots, pits, loose pieces, adhesion, mottling, foreign bodies, discoloration, etc. And whether the capsule leaks powder, adheres, deforms, absorbs moisture, and has color difference. \x0d\ ④ Inspection of outer packaging materials. \x0d\ 4。 Post calibration certificates of temperature and humidity instruments, air conditioning systems and purified water systems in the measurement management warehouse. \x0d\ 5。 Material report distribution. Do a good job in distributing quality reports such as raw materials, auxiliary materials and packaging materials (inside and outside). \x0d\ 6。 After the raw materials, auxiliary materials and inner packaging materials pass the inspection, the inspection report, certificate of approval and material release form will be sent to the warehouse for release. \x0d\ 7。 Records and archives management. Do a good job in sorting out and preserving records and files within the scope of duties and work. \x0d\ 8。 Other tasks assigned by the quality manager. The main responsibility of QA at the production site is 1. Sampling of intermediate products. Intermediates (samples in plastic bottles) of domestic products, foreign trade products and products entrusted by Haizheng are sampled by the company. After receiving the inspection notice, QA shall take samples and send samples in time, and clearly mark the samples. The sampling quantity should be based on the principle of meeting the inspection requirements and avoiding waste. \x0d\ 2。 Monitoring: monitoring the whole production process, issuing production licenses and customs clearance certificates. For details, please refer to Annex: QA Monitoring Contents of Production Site \x0d\ 3. The metrological management department is responsible for posting the calibration certificates of inspection instruments, weighing instruments, measuring tools and meters in the clean production area and the central laboratory. \x0d\ 5。 Report distribution. Do a good job in the distribution of finished product quality reports. \x0d\ 6。 After the materials are released and the finished products pass the inspection, the inspection report, certificate of approval and finished product release form will be sent to the warehouse for release. \x0d\ 7。 Records and archives management. Organize and save batch records and other records and documents. Mainly include: batch record sorting, central control record (weight difference, disintegration, hardness, brittleness, moisture), production workshop inspection instrument record. \x0d\ 8。 Regular inspection and verification of clean area: air exchange times: 1 time/year; Dust particles and settling bacteria: 1 time/quarter. Assist the engineering department to verify and test the air conditioning purification system once a year. \x0d\ 9。 Other tasks assigned by the quality manager. \x0d\ attachment: production site monitoring \x0d\ QA monitoring content 1. Public part:? Is the labor insurance wearing standard? ? Is hand washing disinfection and closing the door behind you in place? ? Does the clearance work meet the requirements? \x0d\ ● Are the following checks made before production: \ x0d \ (1) has a certificate within the validity period; \ x0d \ 2 There are no leftovers in the production room; \ x0d \ (3) Equipment integrity certificate; \ x0d \ (4) The instrument has a verification certificate and is within the verification period; \ x0d \ 5] Tools and containers are marked as "clean" within the validity period. \x0d\？ Is the record filling timely and standardized? \x0d\？ Do dust-producing posts regularly clean dust bags and fill in relevant records? \x0d\？ Are there floor drains and air return openings in each post, and are they cleaned regularly according to regulations, and relevant records are filled in? Are the floor drain and air return opening open? \x0d\？ Does the production equipment have obvious status marks? Does the production post have obvious production status identification? ? Is the production equipment maintained and lubricated as required, and is there a record of use and maintenance? \x0d\？ Are all kinds of wastes produced in the production process cleaned up in time? \x0d\？ Whether there are sundries unrelated to production (such as maintenance equipment, etc.). ) during production? \x0d\？ In the production process, do personnel strictly follow the procedures? \x0d\？ Whether there are contaminated materials and mixed batches (personnel hygiene, process hygiene, mixed materials, etc.) in the production process. )? \x0d\？ Does the material received by each post meet the requirements (batch number, specification and variety) in the production process? \x0d\？ Is the equipment running normally? If there is any abnormality, do you inform the mechanic or workshop manager in time? \x0d\？ If there is any abnormality in the production process of personnel in each position, do you inform the workshop management personnel in time? \x0d\？ Do people in all posts leave their posts, sleep in their posts or work together without authorization? \x0d\？ Have the personnel in each post mastered the contents specified in the SOP of this post? \x0d\ II。 Detailed rules: 1. Material preparation: \x0d\? Is the name, specification, batch number or quantity of each material received every day consistent with the production order? If there is any difference, will it be handled in time? \x0d\？ Are the materials sent every day checked by two people and in accordance with the principle of first in first out? \x0d\？ Are the daily report records of all issued materials consistent with the issued materials? \x0d\？ Are raw and auxiliary materials stored separately according to varieties, specifications and batch numbers? \x0d\ 2。 Smash:? Is the powdery material consistent with the composition list? \x0d\？ Are powdery materials and unpolished materials placed separately and marked with material identification? \x0d\？ Have you checked the material name, quantity and batch number when you collect the materials to be processed in the material preparation room? \x0d\？ Are all materials sent to the batching post marked with complete materials? Has it been verified by the personnel in the batching post? \x0d\？ Are relevant records filled in in time after material processing? \x0d\？ Does the crushing and sieving reach the specified fineness? \x0d\ 3。 Ingredients: \x0d\? Is the name, specification, quantity and batch of each material allocated daily consistent with the ingredient list? \x0d\？ If there are available materials (balance materials) in this batch, is the source of available materials marked (i.e. available material number)? ? Are the materials sent to the granulating post marked and filled in completely? \x0d\？ Whether effective measures should be taken to mix the preparations whose main content is less than 10mg or difficult to mix evenly. \x0d\ 4。 Granulation: \x0d\? Do you check the name, batch number and quantity of each material with the batching staff? \x0d\？ In the production process, if the thickness of wet particles is found to be uneven (or too thick), are measures taken to improve it in time? Whether the particles have black spots and foreign bodies; Whether the colored tablets have too hard and too big particles. \x0d\？ Key monitoring: mixing time, type, concentration and dosage of adhesive (or wetting agent) \x0d\ 5. Drying: \x0d\? Under normal equipment conditions, does the moisture content of dry particles meet the process requirements? \x0d\？ If uneven (or too thick) wet particles are found in the whole granulation process, do you inform the granulation post in time and cooperate with it to take corresponding measures? \x0d\？ Have you checked the name, batch number and quantity of the materials when handing them over to the intermediate station personnel? \x0d\？ Key monitoring: drying temperature, time, loading capacity \x0d\ 6, total mixing: \x0d\? Is there any obvious difference between excipients and granules after total mixing? \x0d\？ Will the particles agglomerate after they are completely mixed? Is it artificial? \x0d\？ Did you check the name, specification and quantity of the material with the sender (receiver) when handing it over to the personnel in the intermediate station? \x0d\？ When picking materials from the material preparation room, do you check the name, batch number and quantity of the materials with the personnel in the material preparation post? \x0d\？ Key monitoring: total mixing time and speed. \x0d\ 7。 Tablet pressing: \x0d\? Did you check the name, specification and quantity of the material with the sender (receiver) when handing it over to the personnel in the intermediate station? \x0d\？ When the equipment is in normal operation, are the parameters such as average piece weight and hardness of the test piece weighed regularly as required? \x0d\？ Do the post personnel find the fragments, sticky sheets, loose sheets, double sheets and thin sheets in time, and take corresponding measures? \x0d\？ Focus on monitoring: tablet appearance, disintegration time, weight difference, hardness and brittleness. \x0d\ 8。 Intermediate station: \x0d\? When sending and receiving each batch of materials, do you check the name, specification and quantity of the materials? \x0d\？ Are unqualified products clearly distinguished from products to be inspected? \x0d\？ If these materials need to pass the inspection before entering the next post, will the intermediate station staff check and confirm them before distributing them? ? Focus on monitoring: whether the intermediate products such as granules, plain tablets, coated tablets, available tailings, and filled capsules are stored in different regions according to the state, and clearly marked, and whether the receiving and sending records are filled in timely and accurately; Whether there is a label on the container and whether the contents of the label are complete and accurate. \x0d\ 9。 Sizing and coating: \x0d\? Did the painting staff check the name, specification and quantity of the material with the sender (receiver) when handing over the material with the post personnel of the intermediate station? \x0d\？ When handing over materials to post personnel in the material preparation room, have you checked the name, specification and quantity of materials with the sender (receiver)? \x0d\？ When the equipment is running normally, is the coated tablet round, delicate, beautiful and colorless? \x0d\？ When the equipment is running normally, is there obvious yellowing, color difference and adhesion of the coated tablets? \x0d\？ Focus on monitoring: the type and concentration of coating slurry, tablet appearance, coating pan speed, inlet air temperature, exhaust air temperature, tablet weight gain, disintegration time limit, etc. \x0d\ 10, aluminum-plastic: \x0d\? When receiving each batch of materials at the intermediate station, is it confirmed that the batch of materials is qualified? \x0d\？ Did you check the name, specification and quantity of the material with the sender (receiver) when handing it over to the personnel in the intermediate station? \x0d\？ Is the heat sealing condition checked at any time during the aluminum-plastic process, and is it handled in time if there is any abnormality? \x0d\？ Are aluminum foil and hard sheets checked at any time during aluminum-plastic process, and are problems handled in time? \x0d\？ Are there any unqualified products such as semi-grain, wrinkled and damaged aluminum foil, bubbles and loose pieces after aluminum-plastic plate selection? \x0d\？ Whether the printed content, product batch number and expiration date of aluminum foil are correct, clear and complete. \x0d\ 1 1。 Packing: \x0d\? Is the product name, batch number, specification and quantity on the material label received from the label warehouse consistent with the packaging instructions? ? Whether the packaging is checked at any time during the production process (whether there are empty boxes and instructions, whether the bottle label and instructions are in good condition, and whether the production date, batch number and expiration date on the bottle label are clear and complete, etc. )\x0d\？ Whether the quantity of drugs is correct. \x0d\ 18, code: \x0d\? Before formal production, have you checked that the production date, batch number and expiration date on the small box after code spraying are consistent with the packaging instructions? \x0d\？ Should the production date, batch number and expiration date on the small box be checked at any time during the production process? \x0d\？ Always check whether the small box is empty (without product batch number, expiration date and production date, etc.). ) or damaged? \x0d\ 19, thermal shrinkage: \x0d\? If there are container codes, are measures taken to avoid container mixing? \x0d\？ Is the thermal shrinkage rate checked at any time during production? \x0d\？ Before putting the small box into the carton, have you checked whether the production date, batch number, expiration date and box number on the small box are consistent with the corresponding contents on the carton? \x0d\？ Is the amount of medicine in each heat shrinkable unit correct? \x0d\ 20。 Large package: \x0d\? During the production operation, have you checked whether the production date, batch number and expiration date on the carton are consistent with the packaging instructions? \x0d\？ Should the production date, batch number, expiration date and box number on the small box be checked before sealing? \x0d\？ After each batch of large packaging is produced, do you count and check the number of boxes with the heat shrinkable personnel? ? Is the number of drug packages correct? \x0d\ 2 1, Wei Qing: \x0d\? Does the internal cleaning staff clean the ground, walls, shoe cabinets and other public areas in time according to the regulations? \x0d\？ Do internal cleaning and hygiene personnel clean the floor drain and air return, prepare disinfectant and fill in relevant records in time? \x0d\？ Does the internal cleaning staff send clean clothes and shoes as required, and fill in relevant records in time? \x0d\？ Do external cleaning personnel clean public areas such as floors and windows every day and fill in relevant records in time? \x0d\？ Does the cleaner clean up the garbage in time every day? \x0d\ 22。 Cleaning of containers: \x0d\? Does each shift clean containers and fill in records in time? \x0d\？ Is the container clean after cleaning? \x0d\？ The cleaned container has been stored beyond the expiration date. Do you want to clean it again and replace the identification card in time?