21 CFR Part 11 And GMP Regulations:

As you may have noticed, the titles of the documents over are relatively short. It’s a veritably typical convention in the medical device manufacturing and other regulated diligence GMP to call the alternate- position attestation” Standard Operating Procedures”, known as bribes. Unless one has a position called”Non-standard Operating Procedures,” I really don’t see a practical or provident reason for long titles.

As long as a short title conveys the idea and leads a stoner to the right place within the system, let’s use it. Quality Works relentlessly promotes this optimization and reduction of waste approach throughout all our publications and consulting work. Let’s not make effects more complicated than they need to be. For illustration, one of our guests named their quality primer as” Quality Management System Quality Manual.” I go, just” Quality Manual” will mean the same for druggies.

Numbering Your Documents

 It isn’t a specific demand of 21 CFR 820 QSR or any other regulation or standard to uniquely number a part or a document. It’s a worldwide practice in utmost attestation systems to give a document or a element a number and a title, and to identify its modification position. As long attestation titles that we bandied before, use of document numbering formats veritably frequently present openings for enhancement.

Once I worked with a cGMP biddable business of lower than 100 people, manufacturing fairly simple surgical instruments. Their attestation system included a many numeration formats depending on the type of a document. One of the procedures had a number 000023- 001, which they simply called” twenty three.” delineations were numbered in a format like 987-323-11-02.

 Is It Respectable To Have Long And Delicate GMP To Read And Flash Back ) Document Figures?

Yes, of course! Is it practical? I don’t believe so! In the illustration over, the procedure number, without the tab, contained six integers. This meant that the system was prepared to handle nearly one million documents or part figures. The company had roughly 150 documents and about the same number of corridor and presumably would noway go beyond doubling those numbers.

However, just reading these figures with successional bottoms in the front may give one a headache, If nothing differently. Unexpectedly, this isn’t the worst case. The business that won our” The Worst Part Number” Grand Prize assigned twelve(!) characters to their part figures in the alphanumeric format.

Make business sense

Still, CAT checkup or other complex piece of outfit, you’ll need thousands or indeed millions of corridor and documents, If you’re designing or manufacturing a sophisticated X-ray. In this case, a long part number format would be demanded and will make business sense. else, save yourself the trouble of writing all those bottoms and make your numbering system practical. One of my guests GMP, who won my” The Stylish Part Number” Grand Prize, numbered their QMS documents as 101, 102, 103, and so on.

Short and sweet! utmost small- and medium- size companies GMP will profit from this optimization approach. After all, is not the part title the stylish designator GMP? Throughout my entire professional career, I worked only with a couple of companies that didn’t use document figures. Their documents were simply linked by unique titles and a two- number modification position, like Quality Manual 01.

Policy- position document

Another debatable issue with part- numbering formats is part number designation. Some operation systems associate a part number with a particular part type. For illustration, 20- xxx indicates a procedure, 30- xxx indicates a delineation, P- xxx indicates a policy- position document, and so on. My experience with a number of medical device manufacturers has induced me in the benefits of a” no designation” system. Three of our guests’ systems that used designation failed.

Just lately, one of our guests reported that he ran out of range in his company’s part- numbering format. The attestation system allowed for assigning accoutrements through a two- number designator within the part number. When the system was designed a many times agone , demanding further than 99 accoutrements wasn’t considered possible. Unfortunately, company’s requirements change over time, and just a many times latterly, the QMS demanded further than 99 accoutrements causing GMP  the being part number format to fail.

An indispensable approach to numbering corridor and documents within your operation system is a” no designation” approach. In such a system, documents or corridor are given successional unique figures within a specified format, anyhow of their position, type, material, operation or other attributes.

 Mark Kaganov was born and raised in Moscow, Russia. He graduated from Moscow University of Radio- electronics and robotization, where he earned his Bachelor’s and Master’s degrees in design and technology of electronic outfit. While attending the university, he worked for the Institute of Plastics, the former USSR’s leading association in the exploration and development of plastic accoutrements .

Quality Assurance

In 1981,Mr. Kaganov immigrated to the United States and continued his professional career in GMP Quality Assurance and Research & Development in the plastics, electronics, and medical device manufacturing diligence. He has worked for major US pots similar as Capitol Records, RCA, COBE Laboratories and Medtronic.

 Since 1990, Mark Kaganov is the Director of Operations and Lead Adviser at Quality Works. The company specializes in furnishing businesses with consulting, attestation, training, perpetration and auditing in the areas of ISO 9001, ISO 13485, 21 CFR 820, ISO 14001 and other operation systems. Among other products, Quality Works offers Integrated cGMP/ ISO 13485 Quality Manual.


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