Essential Elements of a Quality Management System

A good quality management system in a pharmaceutical company can significantly improve the net profit status, high quality medicines for patients, less rework and recall which save more money, good work environment and compliance with local and international regulations.

Quality management is a philosophy. It takes management understanding, commitment and responsibility before introducing and implementing the concept. Once practiced a good quality management system slowly develop or reshape a sustainable organization culture that pays off rapidly.

The initial step of introducing a good quality management into a system is to know the essential elements of the quality system and clear study from where to start. Company objectives should be clearly understood. Policies should be prepared. Then comes the design of the process flow, validating the process, material flow and organization chart. When a good integration between people, process and material is achieved the next step is to putting the integrated system in a state of control. Any deviation from the controlled system must be analysed and corrected.

Some basic but essential elements of Quality Assurance as depicted in GMP guidelines and ISO 9001 guideline for pharmaceutical industry can be listed as: the Preparation of standard operating procedures of a complete system maintaining cGMP principles; Preparation and maintenance of effective change control of quality and master file documentation; Recording and management of manufacturing change control; Recording and reporting procedure of Deviations of your systems; Quality concern investigation process; Customer complaint investigation procedure; Quality audit procedures; Vendor assessment, evaluation and certification procedure; Quality control laboratory procedure, Rework procedures for the defective manufactured products; Procedures on training for manufacturing staffs and recall procedure.

Standard operating procedures and manuals should be written in details and referenced to relevant other documents, so a new starter within the organization should be trained easily and expected to perform as per procedure. The result will be a common standard of activities across the organization, good tractability of work flow, deviations and ease of corrective actions as necessary.

Standard Operating Procedure

You should prepare SOPs, forms, templates and manuals, which can be used immediately as the system runs. Forms and templates should be used for record keeping which your people can follow routinely.

Documentations – Classification, Definition and Approval

Quality and Technical/Master file documents to be created to build up a good quality management system for your manufacturing sites. Definition of documents, their classification, approval requirements and retention requirements should be understood.

Quality Documentation Management and Change Control

Procedures to be created on how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, role of document author, approver, document control officer and satellite file administrator. In this procedures you will also define the numbering systems of different quality documents like audit files, SOPs, forms, templates, manuals, training files, QA agreements, project files etc and their effective archiving system.

Preparation, Maintenance and Change Control of Master Documents

Procedures to be created which will particularly focus on the management of master file documents like specifications, control methods, raw materials, finished goods and packaging specification and test reports, formulation, stability files etc required to generate during the product registration in the market.

Deviation Report System

It is a regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement of your processes and systems. Procedures should be created that describes how to categorize the deviations between production, audit, quality improvements, technical deviations, customer complaints and environmental, health and safety deviations. It should also describes the management responsibilities of initiating deviation, capturing data, analysis, investigation, determination of assignable cause/s, generation of management report and initiatives to be taken on corrective and preventative actions.

Vendor Selection and Evaluation

Procedures to be followed during the vendor assessment and vendor evaluation for purchasing of raw materials, critical and non critical packaging components, laboratory supplies, engineering supplies and imported finished goods from the vendor. These instructions are essential for approving prospective vendor.

Vendor Certification

This procedure aims to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will describe the roles of each department in the process to certify an approved vendor.

Product Complaint Procedure

You should have strong procedure to cover the receipt, logging, evaluation, investigation and reporting system of all complaints received from customers for the marketed products. This procedure should contain step by step instruction to be followed during the customer complaint management like numbering of complaint, registering the complaint, evaluation, determination of assignable cause for the complaint deviation, implementation of corrective and preventative actions, trending of complaints and handling of counterfeit products.

Annual Product Review

Some countries require reports as Annual Product Review to sell your products into their market. So you have to create instructions on how to do annual product review, to evaluate data, trends and to identify any preventative or corrective action that would lead to product quality improvements and report them to management.

Rework Procedure

Procedure should contain the step by step instructions to be followed when the rework of an in-process or completed finished good is required. Product Identification and Traceability The purpose of this procedure is to define the method used for the identification of all contributing materials that could affect product quality and to ensure their full traceability.

GMP Audits

Procedure should be created to describe the process of planning, performing, reporting and follow-up of different audits for your systems like Internal Quality audit, Vendor audit, Environmental Health and Safety (EHS) audit, EHS workplace inspection, Housekeeping audit.

Evaluation of Batch Documentation and Release for Sale

This procedure should describe the process of collection, evaluation and record of batch related document generated during the production of a batch before an authorized person can release the batch for sale.

GMP Training

Effective GMP related training modules to be created for your manufacturing staffs. Training records and reports have to produce on each employee as justified.

Management and Control of Contract Work

There should have procedure to describe the management and control of contract work provided by the contractors for packaging and finished products for your company as well as control of contract works done by your company on behalf of others.

Quality Concern Investigation Process

Procedure should be made that contains instructions to follow when conducting Investigations collection of data and information, analysis, assigning root cause, determine corrective and preventive actions.

Advantage of Face Recognition Security System in Door Access Control

It is not just necessity but it is must requirement. It doesn’t need to say that what I am talking about. I am talking about security. Today, attacks by terrorism organization happen more often. Once you lost then no one would be able to help, even police. But, according to me it is better to take prior steps to prevent.

Today, there are many security systems available in the market. They work on different technologies. Take different factors in concern to authenticate the person. For example, log cards require scanning barcode to give the access to any person and biometric access control require scanning of real human features like finger prints, eye retina, voice and face itself. Each has its own advantage and disadvantage. According to these systems the cost varies as per the security level they provide.

Biometric access control is the new technology which depends on the factors like eye retina, finger prints, voice and signature. So person who wants to access the system require these factors as an authentication. Biometric access control require scanner to scan real human features and convert it to digital format which can be stored.

I want to talk about Face recognition system and its advantages over others. It is one type of system which is based on biometric technology. Face recognition system scans whole face of the person. It includes shapes of face, stains on face, distance between two eyes, distance between eye and nose, retina scan and others. Let me explain the advantages of face recognition system in detail in next paragraph.

Whole face, itself is an advantage

In movies, you might have seen that the thief makes lenses and passes it and access the restricted thing or get entry in restricted region. By this example, you might understand that only one parameter is not sufficient to give full security. It is better that takes full face into scan and concern more than one factor. Same is the case in finger print scan. It is possible to break the security. Again Face recognition has added advantage.

Speed of scan

It is really time consuming to scan the eye. Put your eye against the system. It does require perfect placement of face. Suppose hundreds of persons authenticate themselves takes a lot time. While face recognition system starts scan from the front and until you reach near the gate system opens it for you. In fact, today the systems can scan 100,000 faces per second. It is really good at Door Access Control where thousands of people pass through every day.

Maintenance free system

Biometric access control system is one time cost system. Once you have installed then after you have to maintain a simple database. You can add or remove authorized persons easily and without any cost. On other side, if you use identity card then you have to issue identity card of every authorized person. It leads to more cost. There is also a threat of lost of identity card.

Automatic Continuous scanning

Let me explain, what is it? In other systems, once authenticated, the door stays open for some time. Through that time non restricted person can get entry. Suppose in finger print scanning system, once authorized person put finger door opens. After that two persons can get entry if they are quick. Same case is not possible in face recognition system. The whole door area stays under full security. If one has authenticated and opens the door, and a second person tries to enter without authentication the system detects it and alarms the threat. It means any person without authentication can’t get entry.

So, as I have stated that security is the area where cost is not important. One time cost can hesitate to you but I am sure you will get the reward for sure. My suggestion is, always go for biometric access control and in particular face recognition system. I hope after reading my article you have got clear picture in your mind.

The Importance of Upgrading Your Computer System

If you want to have a computer of your own, then you must understand one thing about them. You see, computers aren’t things you must dispose of after a number of years. It is something you can build on, improve and upgrade. A computer can last you a very long time. If there is one thing you need to know about computers it is that the only thing it needs for longevity is an upgrade. You shouldn’t be afraid to upgrade your system. Doubt is something that’s common with inexperienced computer users. But if you want to have a better system, one that lasts you a very long time, you have to open up to computer system upgrades. Here are a few upgrade suggestions depending on your needs.

If you start to notice a slowing of your systems, then you might need an internal hardware upgrade. A simpler approach would be to reformat your computer, but sometimes, that just won’t do. When it comes to computer speed, the key components are the memory and processor. Memory is very easy to upgrade. All you have to do is buys new memory chips and put them in the empty memory slots in your computer. The processor is a bit harder to change, though. First, you have to make sure the new processor you want is compatible with your current motherboard. If it isn’t then you can either look for another processor that’s compliant, or replace your motherboard with something that’s compatible with it.

Another upgrade you might want to do is shift to a dual monitor system. A dual monitor system is great for people who need to monitor many tasks at one time. This is also great for enhancing the gaming experience. If you want to shift to a dual monitor system, just invest on two LCD or LED monitors and ensure your video card can handle the dual monitor system. You can also invest on a dual monitor stand which saves you a whole lot of space even with two monitors on your desktop.

Upgrades are necessary to lengthen your computer’s life, and once you understand how you can easily upgrade your computer, you will enjoy a faster and more responsive PC without spending too much money on purchasing a new system.

How a Business Can Benefit From the Internet

With today’s advances in technologies and the rapid growth of the Internet having an online presence for a business is very beneficial. A business can benefit in many ways from owning its own Web site. Only a few years ago, if a customer wanted to do business with a specific company he or she would have to physically go to the business or, in less common cases, they could order from a catalog. The development of Internet technologies has created an environment where collaborating with clients, communicating with employees, marketing, and training have evolved to reach a broader group of clients in a more efficient manner.

With development and growth of Internet search engines, the way people find businesses has changed a great deal in the past few years. Someone in need of a product or service in a geographical area could go on the Internet and search for what they were inquiring about. The Internet search would give the person a list of Web sites to choose from. For example; if he or she were in need of a plumber they would use the Internet to search for a plumber in their city. In the search results he or she would find a plumber’s Web site and obtain their telephone number. The use of paper-back phone books to find businesses is slowly disappearing.

Internet technologies and Web pages also help businesses with when and where they can sell their products. With the recent development of online shopping Web sites, also known as ecommerce sites, companies are able to sell products anytime and from anywhere over the internet. The need for the old brick and mortar store is not always necessary. For example; if he or she wanted to buy a certain book they could go to the book store and buy it. With the Internet and shopping Web sites, he or she could find the book virtually and have it mailed to their house. Another type of shopping Web site is the auction site. An auction site allows an individual to bid on something over a period of time, normally for a reduced price. Having an online shopping Web site will greatly benefit a business when selling products, whether that is through an on-line store or through an auction site.

Marketing and advertising a business has changed recently because of the Internet. The traditional methods of advertising a product or service was usually done through printed ads and radio commercials. With the Internet, companies are advertising their products and services on popular Web sites. The more popular a Web page, the higher the charge for advertising space. Other Internet advertising options allow a company to advertise at specific times and specific geographic regions. Internet marketing can expand business advertising to the entire world.

Another great Internet based advertising system is social media. Social media Web sites could be good for a business by linking together groups and other businesses to share information. This can drive new clients to a business. People share information about a product they like and others share it. This type of advertising spreads quickly and can benefit a business.

The Internet and use of a company Web site helps a business communicate. A company can easily communicate with its clients and employees through the use of Internet technologies; such as, email, Web site content, and help forums. If he or she has a question about a product they could easily send the company a message through the help forum or email portal on the Web site. Business communications have changed with the use of online collaboration tools. Using the Internet, a sales person can have access to company contact lists, documents, and calendars that are embedded into the company Web site.

Employee information and training has changed with the use of the Internet. A company can have training modules built into their Web site for initial and recurring employee training sessions. This saves the company time and money. Communicating with employees by using email is also helpful to a business. Policy changes and other information can easily be sent throughout a business by using electronic communication. When a business uses technologies and electronic communication methods it saves money by not wasting paper.

The next generation of Internet technologies and Web sites are the mobile type. Businesses that have traveling sales people need access to company resources using smaller handheld devices. The Web applications made for mobile devices are smaller, fast loading, and do not rely on heavy graphics. The computer as we know it is changing into a smaller, hand held, mobile device. These smaller devices help a business become mobile. Imagine being a traveling business person and having to go through airport security everyday with a large laptop and all its equipment. Now imagine just carrying a handheld device and how much easier it becomes.

Internet technologies and the use of business Web sites are constantly changing and evolving. When a company can adapt and change with the technologies it will benefit because, using quick and effective communicating methods, marketing and advertising strategies, and efficient customer service systems allows a business to move from a brick and mortar store to a potentially global business. Today, if a business does not evolve and keep up with the technology, it will be left behind.