I. Basic requirements
Personnel requirements: The acceptance personnel should have a high school education or above, and should be professionally trained, pass the examination, hold the post with certificates, be familiar with drug performance, have certain independent working ability, have a vision of 4.9 or above and be color-blind.
Acceptance place: waiting area and acceptance maintenance room meeting GSP requirements.
Acceptance equipment:11000 balance, clarity detector, standard colorimetric solution and necessary instruments shall be provided.
Two. Sampling principle and proportion
Sampling should take samples from the original packaging according to the batch number, and the samples should be representative and uniform. The number of samples, each batch of less than 50 pieces (including 50 pieces), 2 pieces, more than 50 pieces for each additional 50 pieces 1 piece, less than 50 pieces as 50 pieces. More than 3 small packages are taken from different parts of the upper, middle and lower parts for inspection. If there is any abnormal appearance that needs re-inspection, double sampling and re-inspection.
Peptide hormones and protein assimilation preparations are checked and accepted by special personnel, and the sampling ratio is the same as above.
Psychotropic drugs of category II must be inspected one by one by two or more people to the minimum package.
Three. Acceptance procedure
1. Inspectors shall inspect imported drugs item by item according to relevant quality standards and requirements listed in original documents (contract, invoice, agreement and warehousing notice). For imported drugs, the supplier shall provide a copy of the Import Drug Inspection Report or the Import Drug Customs Clearance Form and the Import Drug Registration Certificate (Hong Kong, Macao and Taiwan are pharmaceutical product registration certificates) and affix the original official seal of the supplier's quality management institution.
2. Inspection of internal and external packaging:
The inner packaging of drugs should be inspected according to the quality standard of the variety. For drugs that require cleanliness, no pollution, dryness, tight sealing, no leakage, no damage and easy deterioration when exposed to light, measures should be taken to avoid light or other measures.
Drug packaging should be firm, pressure-resistant, moisture-proof and shockproof. Packing mats and cushioning materials should be clean, dry and free of insects. The product name, specification, quantity, batch number, production date, expiration date, approval number, registered trademark, manufacturer, volume and weight, as well as the storage and transportation graphic signs of fragile products, handle with care, face up, do not turn upside down, moisture-proof, heat-proof and antifreeze, and the packaging signs of dangerous drugs must be printed on the outer packaging.
3. Check labels and instructions:
Check the name, specification, manufacturer, approval number, batch number, production date, content of main components (chemicals), loading quantity, registered trademark, indications, usage and dosage, contraindications, expiration date and storage conditions.
Check whether the label is printed clearly and whether the label is pasted correctly and firmly. The label can't be put in the bottle with the medicine.
The text content of API label must include product name, registered trademark, approval number, quality standard basis, batch number, manufacturer, production date, expiration date, gross weight and net weight.
A registered trademark shall be printed in a prominent position on the drug packaging container or label, and the words "registered trademark" or registration mark shall be printed near the trademark. If the drug packaging container or label is too small to print the trademark and mark the registration mark, the trademark must be printed on the larger packaging container or label and marked with the words "registered trademark" or registration mark.
The label of drug reclassification must indicate the name, specification, manufacturer, product batch and sub-packaging unit, sub-packaging batch number and person in charge on the package. The expiration date must be marked after repackaging.
In addition to the contents required by the label, the instructions should also include: main ingredients (Chinese patent medicine), necessary explanations, adverse reactions and precautions.
4. The packaging materials of drugs shall not be printed with words and patterns unrelated to the drugs packaged.
5. Carry out physical appearance and packaging inspection, and the inspection items are separately stated in each dosage form (physical inspection items can be randomly selected according to the specific situation).
6. Acceptance record: The acceptance personnel shall make detailed records according to the accepted drug items and sign them. The retention period of records should exceed the validity period of drugs by one year, but not less than three years.
7. Acceptance period: The transferred drugs shall be accepted within one working day after arrival, and the peptide hormones, protein assimilation preparations and class II psychotropic drugs shall be accepted within two hours after arrival.