Environmental sanitation inspection: check whether the temperature and humidity control in the clean area meets the requirements, whether the workshop and floor are clean (the area where production is not carried out), whether the floor drain is clean and liquid-sealed, and whether it is disinfected regularly.
Inspection of status identification: check whether the status identification of equipment, materials and containers is complete and correct.
Inspection of production operation: check whether the production is carried out according to the production instruction, whether the operation is carried out according to SOP, and whether the control of process parameters meets the requirements of process regulations and production instruction.
Inspection of materials: whether the materials are kept, distributed and used according to the specified contents, whether the materials used in production are correct, whether the weighing is rechecked and whether there is a certificate of conformity.
Priority supervision
First, the 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?
Is the record filling timely and standardized?
Are dust bags cleaned regularly in positions with large dust production, and relevant records are filled in?
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?
Does the production equipment have obvious status marks?
Is the production equipment maintained and lubricated as required, and is there a record of use and maintenance? ?
Are all kinds of wastes produced in the production process cleaned up in time?
Are there any contaminated materials and mixed batches in the production process?
Does the material received by each post meet the requirements (batch number, specification and variety) in the production process?
Is the equipment running normally? If there is any abnormality, do you inform the mechanic or workshop manager in time?
If there is any abnormality in the production process of personnel in each position, do you inform the workshop management personnel in time?
Do people in all posts leave their posts, sleep in their posts or work together without authorization?
Have the personnel in each post mastered the contents specified in the SOP of this post?
Second, the detailed rules:
1. Material preparation:
Is the name, specification, batch number or quantity of each material received daily consistent with the ingredient specification? If there is any difference, will it be handled in time?
Are the materials sent every day checked by two people and in accordance with the principle of first in first out?
Are the daily report records of all issued materials consistent with the issued materials?
Are raw and auxiliary materials stored separately according to varieties, specifications and batch numbers?
2, crushing:
Is the powdery material consistent with the preparation instructions?
Are mixed materials and non-mixed materials placed separately and marked with material identification?
Have you checked the material name, quantity and batch number when you collect the materials to be processed in the material preparation room?
Are all materials sent to the batching post marked with complete materials? Have you been inspected by the batching staff?
Are the available materials filled in the relevant records in time after treatment?
3. Composition:
Is the name, specification, quantity and batch of each material allocated daily consistent with the material preparation instructions?
Are the materials sent to the granulating post marked and filled in completely?
Is there a summary of weighing?
4, granulating:
Do you check the name, batch number and quantity of each material with the batching staff?
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?
5, drying:
Under normal equipment conditions, does the moisture content of dry particles meet the process requirements?
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?
Have you checked the name, batch number and quantity of the materials when handing them over to the intermediate station personnel?
6. Always mix:
Is there any obvious difference between the auxiliary materials and the main drugs in the granules after total mixing?
Will the particles agglomerate after they are completely mixed? Is it artificial?
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?
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?
7, tabletting:
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?
When the equipment is running normally, are the parameters such as tablet weight and hardness tested regularly as required?
Did the post personnel find cracks, sticky sheets, loose sheets, double sheets and thin sheets in time and take corresponding measures?
8. Drying chamber:
Is the name, batch number and quantity of each batch of vegetarian tablets baked every day checked correctly?
Does the temperature and time in the drying process meet the requirements?
Is the batch number and quantity of each drawer on the drying car clearly marked to avoid mixed batch and pollution?
After each batch of vegetarian slices is baked according to the process, should it be cooled before pouring into the container?
9. Intermediate station:
When sending and receiving each batch of materials, do you check the name, specification and quantity of the materials?
Are unqualified products clearly distinguished from products to be inspected?
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?
Do all positions receive the next batch of materials with the release form when picking materials?
10, preparation and coating of slurry:
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?
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)?
Is the coated tablet fine, beautiful and colorless when the equipment is running normally?
When the equipment is running normally, is there obvious yellowing, color difference and adhesion of the coated tablets?
1 1, movie selection:
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?
Are there any half tablets and corner-missing tablets in the selected coated tablets?
12, linkage line:
When receiving each batch of materials at the intermediate station, is it confirmed that the batch of materials is qualified?
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?
Are the counting and sealing conditions checked regularly as required in the production process? If any abnormality is found, are measures taken in time?
Are bottles from different manufacturers or bottles with large color difference used together?
If quality problems are found in bottles or caps during production, are they handled in time?
Is the function of kicking bottles without bottle stickers sampled in the production process? If you find anything unusual, do you inform the mechanic in time?
13, labeler:
Are the contents of each batch of labels consistent with the packaging instructions?
Is the content of the label complete at any time in the production process? If something goes wrong, do you take measures in time? ?
Has the white basket used to put bottles been checked for obvious dirt before use?
14, aluminum:
When receiving each batch of materials at the intermediate station, is it confirmed that the batch of materials is qualified?
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?
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?
Are aluminum foil and hard sheets checked at any time during aluminum-plastic process, and are problems handled in time?
Are there any unqualified products such as half grain and aluminum foil wrinkling after the selection of aluminum-plastic plate?
15, pillow bag:
Is the product name, batch number, specification and quantity on the pillow bag material label consistent with the packaging instructions?
Did the production date, batch number and expiration date on the pillow bag match the corresponding contents in the packaging instructions?
When the equipment is in normal operation, do the post personnel check the sealing condition of the pillow bag at any time, and whether the production date, batch number and expiration date are clear? If something goes wrong, do you take measures in time?
Does the pillow workshop produce two products with different packaging specifications at the same time? If so, is there obvious separation?
16, boxing:
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, whether the production date, batch number and expiration date of the bottle label are clear or whether the appearance of the pillow bag is in good condition, etc.). )
17, code spraying:
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?
Should the production date, batch number and expiration date on the small box be checked at any time during the production process, and is it clear and easy to distinguish?
Should always pay attention to check whether the small box is empty or damaged?
18, thermal shrinkage:
If there are container codes, are measures taken to avoid container mixing?
Is the thermal shrinkage rate checked at any time during production?
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?
19, large package:
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?
Should the production date, batch number, expiration date and box number on the small box be checked before sealing?
After each batch of large packaging is produced, do you count and check the number of boxes with the heat shrinkable personnel?