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.

Think Your Girlfriend Is Texting Another Guy In Secret? Cell Phone Tracking Software Will Help

If you think your girlfriend is texting another guy behind your back, it can drive you crazy. Any time she picks up her phone you want to know who it is and what she’s saying. But it’s not like you can just ask her. And if you’ve ever looked through her phone, chances are all of her texts were deleted. Which of course looks even more suspicious! So how do you find out who your girlfriend is really texting without becoming a crazy stalker boyfriend?

The good news is that cell phone tracking software will help you find out what your girlfriend is texting to another guy. And the even better news? She won’t have a clue that you’ve installed the software so she won’t change her habits. It will be extremely easy to see exactly who she is texting and what she’s saying. Tracking software will even show you what the guy is texting back to her. And even if she deletes her text messages, the software will send copies to a remote server. So you’ll already have a copy and she won’t know how you got it unless you tell her.

How does cell phone tracking software work? It just takes a couple of minutes to install and it works on almost any smart phone. It runs silently in the background of the phone and won’t even show up as an installed or running program. It is silent and almost completely undetectable. So unless you tell her it’s there, your girlfriend won’t know you turned her phone into a private investigator. Which is great, because if it turns out that she isn’t cheating on you or she really isn’t texting another man, she’ll never even know you doubted her. You can uninstall it, or just never tell her it’s there, and she won’t know you were watching her.

Tracking software will do more than just show you what your girlfriend is texting to another man. It will also give you call logs, contact information, and can even turn her phone into a GPS machine. You can log into the remote server and see if she really is working late, or if she really is at the movies with her friends. You can even map her location and catch her if she’s not really where she’s said she would be. It’s a little bit crazy to think that just a small piece of software and a cell phone can do all of that, but it does!

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.

Buying A Refurbished iPhone – The Advantages And What To Look For

Refurbished iPhones are loved because they are cheaper and therefore much more affordable compared to their brand new counterparts. These are phones that have had previous owners, but they have been maintained afresh by the manufacturer improving their quality and making them ready for the market again. Apart from the fact that the refurbished iPhones save money because of their affordable prices, they have a number of other advantages that make them popular.

· The refurbished iPhones come with fresh components considering that their problem areas have been looked at as well as worked on. Faulty parts are also replaced and better ones installed so that the phone functions as well as a new one.

· The software of refurbished phones is reliable. The developers handle all previous glitches making sure that every area is addressed hence you get more reliable software and hardware too.

· Because the refurbished Apple iPhones are made available from approved sellers, they tend to be more reliable and trustworthy compared to buying a used phone from a friend. The approved sellers are in close contact with the manufacturer so they are better in control as well as accountability. Your purchase is much safer when you buy refurbished compared to buying used.

Without doubt, refurbished phones do have a number of advantages and you can consider getting one, especially if you have lost your old phone or it became faulty and you do not have the cash to buy a new phone which can be expensive. But even when buying refurbished, there are critical phone areas that you ought to pay attention to.

Battery life – Even though iPhones come with an impressive battery life that can handle more than 7 hours talk time when they are new, continued use weakens the battery. Find out how many hours of use the phone has gone through and consider whether the battery has been replaced. A refurbished phone whose battery has been replaced is a much better choice because it will easily meet your needs.

Screen damage – Also important to look out for is any visible screen damage. The iPhones have extremely hard glass screens, but if the phone had no screen protector, then it is very possible for the screen to have fine scratches. Important to remember is that such scratches can interfere with proper screen reading and they can also have an effect on the responsiveness of touch screen applications. It is most advisable that you choose a refurbished phone that has a new screen or a screen whose visibility and overall performance you can rely on.

Memory capacity – Earlier versions of the iPhone have little memory and this makes it very important for you to find out the memory size of the phone before you buy. The memory should be large enough so that you can perform all tasks and also have an easy time storing applications you are interested in. Evaluate your needs and relate to the memory size before you finally make your purchase.