What are the relevant management regulations for sample retention, such as raw materials, finished products, intermediate products and packaging materials? I'd like to give you some information about the sample retention management regulations, hoping to help you. Provisions on the management of sample retention are as follows
In order to effectively ensure the food safety of guests and provide a reliable basis for effectively investigating public health emergencies such as food poisoning, according to the requirements of the Food Hygiene Law, the Regulations on the Management of Catering Hygiene in the Army and other laws and regulations, catering service units with more than 111 people at large banquets, important receptions or meals must keep samples of food, and formulate a food sample retention system.
1. A special person shall be responsible for the sample retention work, who shall operate it and record it. Special appliances should be used for food samples, and the refrigerated cabinets should be managed by special personnel.
second, the range of food samples is all the main and non-staple foods processed in the kitchen every day, and no samples are missing.
3. The catering unit must purchase refrigeration facilities and sample retention tools suitable for the quantity of food to be retained, and the sample retention containers should be of appropriate size to facilitate holding, cleaning and disinfection. Refrigeration equipment should be clearly labeled? Special for food sample retention? Logo
4. After the main and non-staple foods are cooled, they must be sealed with plastic wrap, put in a special container and covered, and labeled outside, indicating the number, sample retention time, meal type, meal name, sample retention amount, disinfection time, destruction time, sample retention person, etc., and stored in the order of breakfast, lunch and dinner.
5. The sample amount of each main and non-staple food is not less than 111g, and they are respectively placed in special sample storage containers that have been cleaned and disinfected. The cold storage temperature is 1-11℃, and the sample retention time is more than 48 hours. Relevant regulations on sample retention
(1) The sample retention shall be managed in accordance with the operating procedures, and the samples that need to be retained shall be filled out by the quality control department and sent to the relevant workshops to keep enough samples;
(2) Retained samples should be able to represent the materials or products of the sampled batch;
(3) samples of finished products:
(1) samples should be kept for each batch of drugs; If a batch of drugs is packaged in several times, at least one finished product in the smallest commercially available package should be kept in each package;
(2) The packaging form of the retained sample should be the same as that of the drug in the market. If the retained sample of the API cannot be packaged in the market, the simulated packaging can be used;
(3) In general, the number of samples left in each batch of drugs should be at least enough to ensure that two full inspections (except aseptic inspection and pyrogen inspection) can be completed according to the quality standards approved by the registration;
(4) If the packaging integrity of the retained sample is not affected, the retained sample shall be visually inspected at least once a year during the storage period, and if there is any abnormality, it shall be thoroughly investigated and corresponding treatment measures shall be taken;
(5) There should be records for sample observation;
(6) samples should be kept for at least one year after the expiry date of the drug according to the storage conditions approved by the registration;
(7) If the enterprise terminates the production or closure of drugs, it shall hand over the retained samples to the authorized units for preservation, and inform the local drug supervision and administration department so that the retained samples can be obtained at any time when necessary.
(4) Sample retention of materials:
(1) Samples should be retained for each batch of raw materials and packaging materials in direct contact with drugs. Packaging materials in direct contact with drugs (such as infusion bottles), such as finished products, do not need to keep samples separately;
(2) The reserved sample quantity of materials should at least meet the needs of identification. The total inspection quantity of raw and auxiliary materials and finished products is generally three times, and the packing materials can be selected as 1 or 31cm/ per batch according to the size;
(3) Except for the raw and auxiliary materials with poor stability, the samples of raw and auxiliary materials (excluding solvents, gases or pharmaceutical water used in the production process) and packaging materials in direct contact with drugs should be kept for at least two years after the product is released. If the validity period of the material is short, the sample retention time can be shortened accordingly;
(4) samples of materials shall be stored in accordance with the specified conditions, and shall be properly packaged and sealed if necessary. Provisions on the administration of drug sample retention
Quantity of drug sample retention: the sample retention is at least twice the total inspection quantity (legal sample retention quantity).
the key samples are divided into three categories:
class a: newly-produced generic drugs
class b: newly-produced new drugs
class c: special drugs: refers to the changes in the prescription and process of products, which may affect the undecided varieties; Products under special circumstances? Special circumstances in the production process and varieties with unstable quality;
sample retention by classification:
class a: two batches of samples per year for each variety (in different seasons)
class b: one batch of samples per season for each variety
class c: the director of quality control department may decide as the case may be.
The sample retention shall at least meet the following requirements:
(1) The sample retention shall be managed in accordance with the operating procedures, and the samples that need to be retained shall be filled out by the quality control department and sent to the relevant workshops to keep enough samples;
(2) Retained samples should be able to represent the materials or products of the sampled batch;
(3) samples of finished products:
(1) samples should be kept for each batch of drugs; If a batch of drugs is packaged in several times, at least one finished product in the smallest commercially available package should be kept in each package;
(2) The packaging form of the retained sample should be the same as that of the drug in the market. If the retained sample of the API cannot be packaged in the market, the simulated packaging can be used;
(3) In general, the number of samples left in each batch of drugs should be at least enough to ensure that two full inspections (except aseptic inspection and pyrogen inspection) can be completed according to the quality standards approved by the registration;
(4) If the packaging integrity of the retained sample is not affected, the retained sample shall be visually inspected at least once a year during the storage period, and if there is any abnormality, it shall be thoroughly investigated and corresponding treatment measures shall be taken;
(5) There should be records for sample observation;
(6) samples should be kept for at least one year after the expiry date of the drug according to the storage conditions approved by the registration;