[Original] How to Do a Good Job in Drug Control Quality Inspector-Tang Liu (Central Control Room)
Abstract: Central Control Quality Inspector is a full-time quality supervisor working in the production line, and his work belongs to QA. The main purpose of the work is to ensure that the production process is carried out in strict accordance with the requirements of the process procedures and system regulations, and to prevent the occurrence of non-conformity (unqualified behavior, unqualified products). The contents of control include: personnel (Man), material (Material), method (Method), machine (Machine), measurement (Measurement) and environment (Environment)6 aspects, referred to as 5M1E, the methods used are: on-site sampling inspection (loading quantity, product appearance, clarity), review (formula calculation, weighing of raw and auxiliary materials, printed contents of packaging products), observation (personnel operation status, equipment operation status), etc. The central control quality inspector plays a key role in product quality. Excellent quality inspectors can focus on the production process, find subtle changes, eliminate potential nonconformities in time, ensure the first pass rate of products, truly realize process control and preventive supervision, and fully reflect the post setting value of the central control quality inspector.
Key Words: Drug Quality; Intermediate products; Inspection; Professional ethics
Text: Whether a pharmaceutical factory can produce drugs that consumers can take with confidence requires the joint efforts of every employee in the pharmaceutical factory. From the factory director to the aunt who cleans clothes, every link is complementary. Therefore, how to do this internship is crucial.
To be a qualified central control quality inspector, one must first have the following qualities: ① Having rich knowledge of drug inspection, mastering the quality requirements of relevant drug intermediate products in pharmacopoeia, matters needing attention in inspection procedures, etc. It has good practical ability and the ability to operate the instrument correctly to ensure that the drug is not contaminated in the process of testing the drug. ③ Have a responsible working attitude and seek truth from facts. ④ Have good working habits and strong ability to analyze data.
1. have rich knowledge of drug inspection
master the quality requirements of relevant drug intermediate products in pharmacopoeia, and need to accumulate more knowledge of drug intermediate product inspection in order to correctly check whether the quality of drugs produced in each batch meets the regulations. For example, compound glycyrrhizin for injection is produced in this pharmaceutical factory, which is a freeze-dried product, so its moisture content needs to be checked. However, it is necessary to calibrate the moisture F value of the instrument before moisture determination. Only when this link is operated correctly can the correct data be obtained when the moisture of the drug is determined. The knowledge involved in drugs is something we can't finish all the time. Therefore, in daily life, we need to combine the quality inspection requirements in pharmacopoeia and procedures into actual operation, and remember and skillfully operate the inspection of intermediate products of related drugs as much as possible. Every operation may determine whether this batch of drugs is qualified, so every operation, the matters needing attention also need to be done in advance. In a word, when doing product inspection, we should strictly require our own operation to conform to the regulations.
2. have good practical ability and the ability to operate instruments correctly
"I feel shallow when I get it on paper, and I absolutely know that I have to do it myself". After reading thousands of books, of course, I need to make full use of the knowledge in the book. At this time, practical ability is the key. Good practice will make the inspection process more smoothly. In the process of inspection and operation, the quality control inspector needs to have a thorough understanding of the correct use of various instruments and the cleaning after the use of the instruments. The accuracy of the inspection instrument is an important factor affecting the quality of the intermediate product detection, as the central control quality inspector must understand the characteristics and operation steps of the key instruments, know how to judge whether the instrument is in a normal state, to ensure that the inspection results are correct.
3. have good working habits and strong analysis ability on data
When the relevant inspection work of a batch of drugs is completed, the next thing to do is to process and analyze the obtained data before comparing with pharmacopoeia or other relevant documents to confirm whether the relevant values of intermediate products are within the internal control stipulated by the pharmaceutical factory. However, to do these tasks well, the central control personnel need to have good data analysis ability. The development and change of a thing has its inherent law of development. If you want to discover and predict this law in advance, you need to master a lot of first-hand data. In the face of huge data, we need to use professional knowledge to process and analyze, in order to get reliable conclusions.
4. have a responsible working attitude and lofty professional ethics
do one job and love one job. In the central control room, one must strive to do one's own job well and do every job with a serious and responsible attitude. What's more, what we are now engaged in is the pharmaceutical industry. A little carelessness may cause great consequences. There is a saying that "one drug, two lives". If unqualified drugs enter the market, it will not only endanger life, but also lead to the closure of pharmaceutical enterprises. Therefore, doing a good job in the quality inspection of intermediate products can better control the outflow of unqualified drugs. The central control inspector should strengthen the cultivation of sense of responsibility and professional ethics. A high sense of responsibility and lofty professional ethics can make up for the lack of professional knowledge and skills to a certain extent, because quality inspectors are first dealing with drug production personnel, and personal personality charm can attract and unite relevant personnel to a large extent, so that production supervision can play a maximum role. Excellent professional skills can only play a role through their own professional ethics and the company's rules and regulations. From the perspective of the social responsibility of drugs, we can correctly understand the post value and responsibilities of the central control quality inspector, so as to strictly require ourselves at all times in actual work, perform post responsibilities, and truly play a role in checking and preventing the drug production process, To ensure the safety and effectiveness of the final product.
In a word, if you want to be a qualified central control quality inspector, you need to master a lot of professional knowledge and skills. It is never too late to learn. We still need to constantly supplement the relevant knowledge about the position, and constantly supplement the corresponding knowledge for specific dosage forms and products in actual production. Only based on production practice and constantly expanding their professional knowledge and moral connotation, can the professional quality be gradually improved, so as to truly realize the post value of the central control quality inspector.