According to the" Regulations on Administration of veterinary drugs" and the Ministry of agriculture and relevant documents, the Shandong province already began the GSP certification, as the person in charge of the enterprise, we must carefully analyze the current situation of application of veterinary drug GSP, organization of enterprises the implementation of relevant personnel of veterinary drug GSP certification, fully implement the veterinary drug GSP certification work, planned, step by step to promote. According to the survey, are ready to GSP certification enterprises reaction somehow emphasis should be placed where, for this, the author of the GSP certification on 4 are summarized as follows.
One, strengthen the construction of hardware
Hardware facilities are veterinary drug enterprise infrastructure, is to ensure the normal circulation of veterinary drugs in circulation essential condition, is also a veterinary drug GSP certification review of one of the important links. Veterinary drug GSP implementation, the place of business, warehousing, personnel are rigidly set. For example: business places a minimum of not less than 30 square meters, its internal facilities, equipment and distribution of variety and size to suit; warehousing requires of "five prevention" facilities, with the corresponding area, to ensure drug quality requirements under normal temperature storage library, cool Library ( cabinet ), refrigerator ( cabinet ) and other storage and related facilities, equipment; with its mode of operation, varieties, corresponding to the size of the veterinary drug quality management, veterinary specialty technical personnel and other staff. If the enterprise does not have a certain financial capacity, in these areas to invest capital, hardware facilities improved, GSP certification is mentioned. So the hardware construction is certified by GSP Chongzhongzhi is heavy.
Two, strengthen the construction of software
The enterprise wants to pass the attestation of animal drug GSP, hardware facilities to complete, but if you do not have a set of strict rules and regulations to guarantee the implementation of, also can be only " hope to sigh". Therefore, veterinary drug enterprises must work content of the formation of written materials, as a standard guide for practitioners strict implementation of. GSP software is programmed to designate a person to prepare, from the management standard, operation standard, records and vouchers and other aspects of the establishment of a set of its own for the scientific and strict operation procedure. In the preparation of GSP software and the implementation process can consult experienced GSP certification personnel conduct regular guidance, Zha Quebu leaks, enhanced by probability.
Three, do a good job of staff training
Practitioners quality deciding whether the smooth implementation of GSP certification, again good hardware facilities, a good standard, executive force is equal to zero. To do a good job execution work first of all to improve the integral quality of personnel, must from the technology, GSP software and other aspects to strengthen staff training, to put the mental essence of GSP and operation standard, specific fulfil each employee. Training staff must be done in a planned hierarchical, material specification, evaluation results of heavy, heavy filing records.
Four, pay attention to the details of the implementation issues
" Detail decides success or failure", any minor omissions, may lead to the failure of GSP certification. In the GSP certification work to pay special attention to the following details:
One is on display in veterinary medicine must be strictly in accordance with the veterinary prescription drugs and non-prescription drugs, veterinary medicine raw materials and formulations, with veterinary drugs and topical drug separately from the display; according to the dosage form or use classified display, category label placed accurately, legible; dangerous goods or not suitable for display of veterinary drug products should not be displayed, to Chen Lieshi, only display empty packaging; demolition of veterinary drugs or packaging pieces of Chinese medicine should focus on counters display, and retain the original packaging labels, brochures.
The two is in the warehouse district division and implementation of color management. Quarantine medicines, drug zone yellow area return; qualified zone, for drugs District green; unqualified drugs District red. Drugs between the ground and shall have mats, with dust-proof, moisture-proof, anti-mildew, pollution prevention and pest control, birds, rats and other equipment, storage of flammable, explosive, strong oxidation, corrosive and other dangerous goods warehouse shall install explosion-proof lamp. Easy to string together flavour drugs, Chinese herbal medicine, Chinese medicine pieces, stored separately, and a clear sign.
Three is a class of narcotic drugs, psychotropic drugs, toxic drugs for medical use, must be devoted to library counters store, and installation of alarm, double lock custody, only Zhang records, account. The two kind psychotropic drugs must have relatively independent storage areas, strengthen the account goods management.
The four is to strengthen the warehouse temperature and humidity monitoring and control of the temperature and humidity, daily on the afternoon of the monitoring time, and make records.
Five is the personnel must wear uniform and marking, regulate the establishment of various books, for all types of files to timely file.