On May 18, the medical website was launched in 2017. The flights were carried out in full swing, and provincial and provincial departments of drug and drug administration were recently carried out flight inspections in hainan and guangdong provinces. So, what is the change in the focus and the method of inspection? This paper is based on the recent analysis of flight inspection in hainan province. 

 

Important projects should be noted 

 

The computer system is the key. Including the computer authority setting, the rationality of the computer process, the existence of the operation data, whether the accounting is set up, the existence of the ticket, etc. 

 

Finance is the key. Including query financial system to verify whether there is two sets of zhang (zhang, a set of a set of drug safety tax bill), check whether there is a personal bank transfer information to the company or the company to individuals as well as cash transactions, etc. Check the financial report to verify the actual scale of the operation and the scale of the drug operation. 

 

The system document is consistent with the actual operation. The author thinks that the disconnection between the quality management system and the actual operation is the problem for most enterprises. For example, the process of validation of key maintenance varieties, such as near term and key maintenance, shall be carried out in accordance with the quality management system of the enterprise, as the GSP is not strictly stipulated. However, many enterprises have caused the quality management system to be out of sync due to the high mobility of people and the lack of training of new employees. Businesses should be given enough attention. 

 

The authenticity of the document. Documents such as audit file, replenish onr's stock review files, etc., these records document a lot of enterprises are the same year after year, even if need maintenance summary analysis according to a certain period of time is a summary of the maintenance of the form is copied in the first quarter, this can make such as unqualified parameters such as number of varieties such as inconsistent with the actual situation. Documents to reflect the truth of quality management are true effective, better reflect the attitudes towards quality management enterprises, also from the side reflect the quality of the enterprise management level. 

 

Other. Such as the presence of a licensed pharmacist; Cold-chain varieties, special management of drugs and management requirements of the country have special varieties of storage to transportation, purchasing compliance, etc., are the focus of the flight check. In addition, the new addition of GSP, such as transport records, the establishment of a traceability system and the running of the GSP, became the focus of recent flight inspections. 

 

Check for more details 

 

The flight time to inspect the site of hainan province basic for two days or so, and check the content completely covering national administration of on-site inspection guidelines, there are companies reflect very detailed examination, even the enterprise own didn't realize that problems have been exposed. 

 

For example: 1. Does the chain of the cold chain need to be reconfirmed by the company's own cold chain equipment? Many enterprises take it for granted that they do not need it, but according to the requirements of the provincial department of medicine in hainan province, they need to be validated. 

 

2. Many companies receiving acceptance drugs did not check with cargo traffic single template, with actual delivery of the goods caused by peer list with along with the goods in the first camp enterprise archives of single style is inconsistent. This kind of problem prompt, the enterprise in the actual management process need to make the quality management to be thin, do essence, the GSP concept runs through the various positions. 

 

Compliance management is meticulous 

 

GSP should be in line with the actual operation of the company. The new version of the GSP, which adds a lot of content to older versions, seems to be detailed, but the basic standards of the industry are not enough to guide the business. Generally, corporate standards should be higher than industry standards. For pharmaceutical wholesale enterprises, the scope and scale of operation is the basis of the quality management system. 

 

(1) the impact of the scale of operation: the size of the enterprise will be different, and the quality management system will be different. The generation of the purchase order, such as large enterprises set up is recorded in the single member complete purchase order entry under authorization again by buyer approval, create purchasing records by GSP system. But for small businesses, there is only one person in procurement and sales and even in the business sector, so procurement is done by one person. For example, if information management is not set up and information administrators are set up, there is no strict regulation. In addition, an enterprise is equipped with automatic warehousing equipment, and equipped with PDA system used in picking and acceptance, because of the large scale of enterprise management, produce huge amounts of operation data every day, so the enterprise computer data security, effectiveness is especially important. But a small business, because of its small size, does not need to set up the information management department alone, simply with a computer administrator. 

 

(2) the scope of business, mode of operation: the influence of the concept in many enterprises classified as a data category, will remain in the system documents and files in a lot of content is copy other documents of the company. In fact, some companies do not violate the GSP requirements, but they do not comply with their own system documents. In the guidance process, often find such as stock review, system file, at least once a quarter, but once a year, quality policy target appraisal system file, once a month but for once a year. 

 

Therefore, the author thinks that the enterprise internal audit on the basis of more should is the enterprise own quality management system documents, and not just the GSP and other laws and regulations, enterprises should be higher than the industry standard and national standard, as a guide for daily operation enterprises quality management system documents and guidelines, should return to its own position. 

 

All departments should strengthen communication, and the GSP consciousness should be carried out to every post. GSP involves personnel (recruitment training), finance (invoice), quality management, storage and transportation, business (purchasing, sales), etc. Quality control department should closely with all departments to communicate, do the training on a regular basis, to explain in detail the latest laws and regulations and other department before the decision is also should take the initiative to contact the quality control department to confirm compliance with the GSP and quality management system documents, to ensure the quality of work process the company's position risk control. 

 

The first step is the first step. From GMP and GLP development can see, the national laws and regulations is gradually improve, more and more standardized, the process of regulation on businesses is also will be more and more strict, so the enterprise only actively take the initiative to change and adapt to win the future. (author: CIO compliance assurance organization)