Material technical requirements for clean workshops
Material requirements for clean workshops
(1) A management system shall be established for the purchase, storage, distribution and use of materials used in the production of pharmaceuticals.
(2) The materials used in the production of pharmaceuticals shall comply with the pharmaceutical standards, packaging materials standards, biological product regulations or other relevant standards, and shall not adversely affect the quality of the drugs. Imported APIs should have a drug inspection report from the Port Drug Inspection Institute.
(3) Chinese herbal medicines used in the production of pharmaceuticals shall be purchased according to quality standards, and their production areas shall remain relatively stable.
(4) Materials used in the production of pharmaceuticals should be purchased from units that meet the requirements and in accordance with the regulations.
(5) Materials to be inspected, qualified and unqualified shall be strictly managed. Unqualified materials shall be stored in a special area, and there shall be obvious status marks that are easy to identify and shall be dealt with in a timely manner in accordance with relevant regulations.
(6) Materials, intermediate products and finished products that have special requirements for temperature, humidity or other conditions shall be stored in accordance with the specified conditions. Solid and liquid raw materials should be stored separately; volatile materials should be treated to avoid contamination of other materials; net medicines processed and processed should be cleaned or packaged and strictly separated from unprocessed and processed herbs.
(7) The relevant regulations of the State shall be strictly implemented for the acceptance, storage and storage of narcotic drugs, psychotropic drugs, toxic drugs (including medicinal materials), radioactive drugs and flammable, explosive and other dangerous goods. The acceptance, storage, storage, use and destruction of bacterial strains shall be carried out in accordance with the State's regulations on the storage of medical microbial strains.
(8) Materials should be stored according to the specified period of use. If there is no specified period of use, the storage should not exceed three years. After the expiration, the materials should be re-inspected. If there are special circumstances during the storage period, it should be re-inspected in time.
(9) The label and instruction manual of the drug must be consistent with the content, style and text approved by the drug regulatory authority. Labels and instructions for use must be printed, distributed, and used after being proofread by the company's quality management department.
(10) The label and instruction manual of the drug should be kept and used by a special person. The requirements are as follows:
1 Labels and instructions for use should be placed in special counters or special stocks according to the variety and specifications. They should be issued according to the batch packaging instructions and collected according to actual needs.
2 The label shall be counted and issued, and the recipient shall check and sign, and the sum of the number of use, the number of damages and the remaining number shall be consistent with the number of the recipient. The damaged or remaining label bearing the batch number shall be counted and destroyed by a special person.
3 Labels should be issued, used, and destroyed.
We specialized in developing, manufacturing and trading of BBQ grills and series of metal & plastic products since 2010. Our main products are Portable BBQ Grill, Folding BBQ Grill, Camping Stove, Rotating Grill, Electric Grill, Fire pit BBQs. BBQ Grills allow you to enjoy the happy time with your families,friends.
rotating barbecue grills,ceramic bbq grill,electric grill bbq,ceramic bbq grill,collapsible bbq grill
TAISHAN YUEXIN INDUSTRIAL GROUP LIMITED , https://www.gdmetalplasticproducts.com