- Order a business license from the Georgia Department of Revenue. Their online web portal allows you to register your business and get your license. Later you can pay your taxes and file returns on this web portal as well. Some counties may also require you to have a local sales license so make sure you contact the county business office to confirm.
- Choose whether you are going to base your catering business out of your home or a retail space. If you are starting small, it is more economical to simply prepare the dishes at home then transport to the event. This will save you the cost of renting a space until your business supports that level of expense. Contact the U.S. Small Business Association’s Georgia District Office to receive assistance for loans or grants to help with your start up costs. Regardless of where you cook, you will need the proper equipment. Large scale catering requires a commercial size oven unless you have the time to cook multiple items separately.
- Join the Georgia branch of the National Association of Catering Executives (NACE). This organization offers training courses along with the chance to network with other people in the catering business. There is an annual conference where members get together and review the latest ideas and technology in the hospitality industry. The NACE also provides a Professional Catering Executive certification to members that successfully complete the training program. There is also a Georgia branch of the National Restaurant Association, which include caterers in their membership. Education and certifications are also available.
- Experiment with Georgia-style menus such as seafood and traditional southern recipes of fried chicken, greens, and peach cobbler. The coastal region around Savannah is well known for its shrimp and grits, lowcountry boil and gumbo. Include these selections as menu staples to get started. You can add other items as your customers request them. Purchase linens and serving equipment from a wholesaler. Depending on your budget, it may be easier to buy a generic set-up such as white and black linens in round and rectangle. Keep serving platters and trays simple by using restaurant quality commercial size silver trays and warming dishes. As your business grows, you can always diversify your presentation options.
- Advertise with event venues, wedding planners, and churches. Some popular Georgia venues include the Tybee Island Inn, the Gardens at Great Oaks, the Margaret Mitchell House and Bryson Hall. For more casual events, consider working with the University of Georgia and Georgia Tech to cater sporting events. Ask to coordinate efforts with local bakeries to provide the food while they provide the desserts. This may be a good way to increase your client base until you have established your business. Set up a website with photos of prepared menu options to give potential customers an idea of what the food will look like. Provide your contact information, credentials, experience and include descriptions of the types of events your company can support so customers can make decisions about whether your catering business is a fit for them.
More Than Just Burgers
- Many different types of fast food establishments exist, each one with a niche in the marketplace. These restaurants cater to the public’s desire for different types of food. The most common type of fast food restaurants serve beef burgers and french fries. Other establishments serve only fish, chicken or similarly popular meals. Still, other niche restaurants cater to those who want only one type of food in varying degrees of presentation.
Avoiding Stiff Competition
- The proximity of one fast food restaurant to others may have an effect on its success. If another establishment that serves identical meals is within a close range, the result will be increased competition and potentially lower gross sales. A restaurant that is near a similar one must attempt to draw customers from the competition with promises of additional benefits, features and lower prices. Obviously the highest chances of success exist when there are no other fast food restaurants close by.
Attracting a Large Customer Base, Literally
- A fast food restaurant’s size may have significant effect on its success. Larger buildings can serve more customers at one time. Providing customers with appropriate seating in a comfortable environment increases the likelihood that they will stay for longer periods during meals, thereby increasing the chances that additional products, like desserts, may be purchased. Additionally, larger buildings allow for a more significant surface area for outdoor advertising. Signs, banners and other creative marketing methods can be applied to the exterior of the building, resulting in dramatically higher exposure to passersby.
Location, Location, Location
- Demographics may be the most significant factors affecting the success of a fast food restaurant. Restaurant owners should examine the ratios of male to female, average income, education levels and other essential characteristics of the people living nearby. Advertising and marketing can be tailored to take advantage of the demographics information. Demographic information can be effectively used in drawing the local residents to the fast food restaurant.
What’s In a Name
- Something to consider is that many fast food restaurants may have certain measures for success based simply on their major trademarked names. Think McDonald’s, Burger King and Wendy’s and their quality management that lends itself to their financial success. Those establishments that are the nation’s leading fast food chains have a chance at attracting a number of customers merely because of familiarity and convenience. Predictability concerning products and prices often appeals to a large number of people.
- Evaluate what skills, equipment and assets you have already that you can use to start a business. For example, if you have a computer, Internet access and writing skills then you can start up a freelance business with little or no money.
- Determine what type of business you want to start. Take into consideration your interests, your current skills, how much time you want to spend on your new business and what types of businesses you can start with no money.
- Research your business options. If you are interested in online businesses then you may want to look at freelance art businesses, freelance writing businesses and freelance data entry businesses. If you have your own office equipment, and if you have bookkeeping experience, then you can set up an outsourcing secretarial service.
- Scan through your Sunday classified ads for companies that are offering telecommuting positions. This is a great way to make business contacts and to get your home business off the ground.
- Read through online job listings for telecommuting positions or consulting positions. Sites like “Craigslist” and “Monster” are both great places to find job opportunities.
- Create a business plan to help you organize your business and create goals for its future. You can download a business plan template free online. Use this as a guide to help you create your business’s business plan.
Microsoft Word contains many professionally-designed templates to facilitate the creation of an attractive card to promote you and your business. Once you select a template, a page full of identical cards ready for editing is displayed in your document. Customize one, and it is replicated to the others. Then, print on the paper of your choice.
Design the Card
Your business card provides information to your customers that goes beyond the printed text. A well-designed card makes a good, lasting impression representing you and your business. When designing your card, select a font and size that are easy to read… not too small, not too ornate. Include all of your contact information and a high quality graphic if it’s relevant. Keep ample space between elements on the card to give it a clean, uncluttered look. Make your business cards effective by investing a little time in the design phase.
Create the Card
In Word, click the File menu and then New. Enter “business cards” in the Search for Online Templates field and then press Enter or click the Search icon. Select a business card template from the list. An overview of your card describing the size and the Avery-compatible products displays. Use the left and right arrows that flank the overview to flip through other templates. Alternatively, type your product number in the search box to ensure that your chosen template matches your business card paper.
Once you find an appropriate template, click Create. At this point, focus on the card layout more than anything else. Replace the text on one of the cards with your own. To edit a text box, click on the box and type to replace the existing text. Edit all text boxes. If the template includes an unnecessary placeholder — a website for example — highlight it and press the Delete key to remove it or right-click and choose Remove Content Control. If the selected template has a placeholder for a logo, select the Replace with Logo box and click the Image icon to browse for a file or to search for an image.
- Versions prior to Word 2013 do not automatically propagate the contents of your edited card to the other cards on the page, so you need to copy the card and paste it into each unedited card. Be careful: The trick is to select the entire card rather than an element of the card, such as a text box.
Print the Card
The final step is to preview and print your cards. Do a test-run by printing one page on regular paper before printing many pages on your special business card paper. This provides the opportunity to double check for accuracy and to ensure that you’re satisfied with the final appearance. If the document doesn’t print as expected, go to the Mailings tab, choose Labels, and then Options. Select your product vendor and then find your product number. Commonly used Avery products such as #5371 for a laser printer and #8371 for an inkjet printer produce standard size white business cards, but there are many other vendors and products listed. Click the Detail button if minor adjustments to dimensions are needed. Find other Avery options on its website.
- It’s worth investing in quality paper so that your cards feel sturdy rather than flimsy. Consider a heavier weight card stock, around 80 lbs. The finish can be glossy or even textured, but most people go with a smooth matte finish.
- As technology becomes more and more integrated into our life and society, more and more competent workers are needed. Whether it’s programming, entering data for website or databases or working in a factory, more and more high-tech are jobs available every year, encouraging workers to refocus their abilities. Continuing-education classes to learn new technological skills may be necessary for some.
- U.S. agriculture is an enormous industry, producing much of the nation’s food and fiber, ranging from processed foods to the booming organic food market. Jobs available in this sector range from building the tractors and machines that farmers use to the science and chemistry of what makes crops grow to being a farmer. Varying degrees of formal education are required.
- An industry that first truly boomed in the United States, entertainment always has job openings for creative and business-minded people in a wide range of capacities. From lawyers to artists to teamsters, the entertainment business employs just about every skill set to bring imagination and stories to television, the movies and now even cell phones. While the hubs of the entertainment industry are Los Angeles and New York City, the technological revolution has made creating your own entertainment easier than ever, allowing those with the necessary skills to work from just about anywhere.
- Register your business name with the New Jersey Division of Revenue. They are located in the city of Trenton at 33 W. State St. You will receive a certification with your name and the business name on it.
- File an SS-4 form with your local IRS office and get a Federal Employer Identification Number (FEIN) from the IRS. There are more than 10 locations in New Jersey, including one at 30 Montgomery St. in Jersey City and one at 165 Passaic Ave. in Fairfield. You can also fill out an SS-4 form online.
- Apply for a retail food license. Contact your local Bureau of License & Inspections in New Jersey. There is one located in Camden at 520 Market St., or call 856-757-7131. There is an application fee of $159 for caterers and there are other documents that are required with the application, including two passport photos, a copy of your social security card, a copy of your driver’s license, and proof of ownership or leasing of the place you plan to have your catering business.
- Apply for permits. New Jersey requires each event that you cater a separate application for a permit. The application will require various personal information, including your name, address and location of the event that you plan to cater. There is a $100 fee for the application.
- Read the state of New Jersey’s requirements on food safety and regulations through the Department of Health and Senior Services. Stay updated on the latest changes in regulations to be permitted by the health inspector.
- Blast furnaces account for up to 40 percent of the total amount of oxygen used in a typical integrated steel mill. Oxygen is injected into these furnaces through spargers–devices used to spray gas into a system–to enrich the air. This process increases the productivity of the furnace. It also serves to lower coke consumption by facilitating the addition of powdered coal and natural gas to the furnace. Using oxygen in a blast furnace lowers the overall cost of production.
Basic Oxygen Furnaces
- In basic oxygen furnaces, oxygen is used for decarburization–the process of decreasing the level of carbon in metals–and the conversion of hot metal formed in a blast furnace to liquid steel. This process typically accounts for about half the amount of oxygen used in an integrated steel mill. When oxygen reacts with silicon and carbon, it produces a large amount of heat. This heat is enough to melt scrap metal in large quantities.
Electric Arc Furnaces
- Electric arc furnaces have three primary uses for oxygen. Oxygen is used to run oxy-fuel burners used for heating and melting scrap metal. Oxygen is used in high-velocity lancing. High-velocity lancing is used in localized scrap melting processes, decarburization of steel and slag foaming. Oxygen is used in sub-sonic injection processes used for post combustion of carbon dioxide.
- Rotary furnaces used to depend on sulfur oxide and nitrogen oxides to heat metal. They have since switched to pure oxygen. Using pure oxygen allows for the avoidance of heat loss, thereby reducing the amount of time the furnace needs to complete tasks as well as its overall costs.
Steel Reheating, Cutting and Burning
- Oxygen is used in steel reheating furnaces. In particular, oxygen is used for enrichment or two run oxy-burners, as blast furnaces and rotary furnaces, respectively. Using oxy-fuel burners in this process contributes to reduced fuel consumption when compared to other gases. High-purity oxygen is used in cutting and burning processes to run automatic cutoff torches, as well as in the cutting of crops and other forms of mill scrap.
- Write down all of the strengths that currently exist for the industry you are analyzing. A strength is anything that is beneficial about the industry. An example of a strength would be the potential for long-term growth. Don’t focus on your company, focus on the industry you are analyzing.
- Write down a list of all the industry’s weaknesses. For example, a weakness might be that the industry is highly competitive or volatile. Consider anything that would be disadvantageous about entering this industry.
- Write down a list of all the opportunities in the industry. For example, are there many untapped markets for the industry or opportunities for technological breakthroughs? List any opportunities in the industry that may be exploited in the future.
- Write down a list of all the threats to the industry. For example, a threat to the oil industry could be environmental legislation, or a threat to the television industry could be Internet entertainment programming. A threat is anything that has the potential to disrupt or damage an industry.
- Analyze the strengths, weaknesses, opportunities and threats you have just laid out. What you want to determine is if the strengths and opportunities are greater than the weaknesses and threats. This is a difficult process. You should consider the number in each category, but you should try to understand the impact of each category overall.
- Launch Microsoft Word and open a blank document. If you are using business letterhead to print on, adjust the margins to accommodate the letterhead style. Otherwise, use the default margins.
To adjust the margins for your letterhead in the 2007 version of Word go to the “Page Layout” tab and then click on “Margins.” At the bottom of the drop-down menu, select “Custom Margins” then adjust to your needs. In an earlier version of Word (1997-2003), go to the “File” menu then select “Document Setup” to adjust margins.
- Choose a font. Traditionally, business letters use a serif font such as Times New Roman. Recently, there has been a trend in using sans-serif font. If your business or brand has a specific font established in the brand guidelines, use that font. If your brand has not established a font style yet, stick with professional-looking serif and sans-serif fonts such as Times New Roman, Helvetica, Tahoma, Garamond or Arial. Do not use a font downloaded off the Internet.
In the “Paragraph” tab set the after spacing to around 9 points. This will ensure that your paragraphs have enough space between them.
- Set up the heading for your business letter. First, add the return address of the sender as well as his name, title and business. If this letter will always go out by the same person add her specific information here. Otherwise, use generics such as [employee name] and [employee title]. Each item goes on a separate line. Either use shift+enter to advance to the next line or highlight all the information and go back into the “paragraphs” tab and set the before and after space to zero.
Advance twice using the “Enter” button, then add a line for the date. Advance twice again to enter in the recipient’s information. Follow the same format as you did above for the sender’s information. Line one will be the recipient’s name. Again use the generic set up such as [Mr./Ms. recipient’s first and last name]. Following the name, add the recipient’s title and employer. The address comes after. A proper set up will look like the following:
[Mr./Ms. Recipient’s Name]
- Move on to the salutation, body and closing of the letter. Hit “Enter” once after the recipient’s information and add the salutation in the format of: Dear Mr./Ms. [Recipient’s Name]; Hit “Enter” again.
- Begin the body of the letter. If you will be using the same text on every letter, enter in the entire letter as you want it written. Otherwise, add a [paragraph 1], followed by hitting “Enter,” then a [paragraph 2], “Enter,” and continue until you have enough paragraphs.
- Add your closing by hitting the “Enter” button twice and type a closing line. The most common closing used in business letters is “Sincerely.” After your closing, hit “Enter” twice to leave enough space for a signature. Following the blank space for the signature, add the following three lines: sender’s name, sender’s title and sender’s business name.
- Go to “Save As” from the “File” drop-down menu. When the “Save As” box opens, go to the “Save As Type” drop-down menu and select “Word Template.”
It goes without saying that the pouches are in huge demand in the food industry. Large numbers of food products need to be manufactured in pouches. Milk, for instance, is one of the most important products that need to be packed in pouches. A milk pouch packing machine is certainly of great help in this context. The machinery is designed in such a way so that it makes use of special sealing capacity to tighten the pouch. In addition to that, the manufacturing is carried out in such a way so that the pouch remains air tight and enhances the overall longevity of the milk.
Growth of the Packaging Industry:
The packaging industry is growing at a steady rate in the recent years. Manufacturers of liquid and powdered products look for some of the highest qualities of machines to produce pouches. After all, it requires extreme care and caution to export the milk and other liquid products across the world. For most milk manufacturers and exporters, the packaging solution certainly matters a lot. In this context, the importance of an appropriate and high quality milk pouch packing machine cannot be overlooked at any cost. It definitely helps in serving a great purpose, as a whole.
In the recent years, most machines are automated. As a result, a product specification can easily be entered while manufacturing these pouches. The weight, size and capacity can be pre-specified prior to the manufacturing process. On the basis of that, it can customize a product as per the requirements. These machines are also designed for accuracy, speed and quality. Consequently, it results in freshness and longevity of the milk filled in the pouches. In fact, these pouches also help in retaining the mineral content of the pouch.
Multiple Pouch Formats:
With the sophistication of technology, it will not be difficult for you to find out the best machines for pouches. Moreover, you will even find a milk packaging machine that can manufacture multiple pouch formats. Therefore, it will not be difficult for you to find one that best suits your needs. The innovative packing solutions are tamper-resistant, leak-proof and non-resistant to chemicals. Apart from pouches, you can also get in strips, tubes or boxes. It is up to you to decide how you want to pack the milk and on the basis of that you can make your selection.
Quality Is Crucial:
It is a well-known fact that quality is often the major factor that helps in determining the ideal packing solution. Moreover, the milk packaging machine should also adhere to the latest industrial standards in manufacturing pouches or other types of packaging solutions. This in turn also results in sturdy packaging that tends to be attractive, as a whole. The products contained in the pouch can help in maintaining a strong shelf life and attract the attention of customers. Moreover, the pouch formats used should be unique and innovative and maintain the freshness of the products in great ways.
Financial Crises has hit the manufacturer of the medicines considerably, many of the pharmaceutical giants have declined the new job recruitment that they were making every year. In comparison to the last year, the business of the pharmaceutical giants is decreased by the 31%. Even the drugs that were selling like the hot cakes in the pharmaceutical market are now feeling the less demand from the customers. The pharmaceutical companies are even cutting down their employee strength by either removing the trainee employees or by reducing the salaries of the permanent employees. The recruitment done by the pharmaceutical industries in the last year is only 3%, very less in comparison to the recruitment done in previous years.
Even the other pharmaceutical giants like Merck and Sonafi Aventis has declared that they will not be doing any new recruitment for the next year and no bonuses will be given to the employees. They have even declared that the sales executive who will not be able to achieve their targets will be given a pink slip the next month. No employee in the company will be given the benefits of the performance incentives and also the unnecessary expenses done by the company to promote the products will be cut down. Even the lots of money spend on the packaging and distribution of the products is tried to be cut down. The promotional campaigns are also been shut down in order to cope up with the current economical crises. Even the cuts in the salaries of the employees have been done by some pharmaceutical companies in order to save the money.
The companies manufacturing the branded drugs are facing a lot of competition from the low cost drugs manufacturers and thus this competition is one major reason why pharmaceutical industries manufacturing branded drugs are facing the heat of the financial recession. Low cost drugs are the exact replicas of the branded drugs and show the same effectiveness, additionally; they are available at very low costs than the branded drugs. This phenomenon of best quality available at lower price has helped remarkably to increase the sale of low cost drugs, and thus has decreased the sale of the branded drugs. The sale of the low cost drugs is increasing and the sale of the branded drugs is decreasing because of the exceptional high costs kept by the branded drugs manufacturers.
The government policy to promote the low cost drugs has made consumer aware of the low cost medicines and thus are going only for them. This has affected the sale of the branded drugs manufacturer. The government has also reduced the taxes on the low cost drugs in order to promote the low cost drugs. Thus, the sale of the branded drugs is affected considerably due to the ever increasing demand of the low cost drugs. The pharmaceutical giants thus have to eliminate discretionary spending, overtime, and temporary workers to match up with the prices of the low cost drugs. Cost cutting is only way through which pharmaceutical giants can cope with the recession factor. Many of the pharmaceutical companies have even asked the drug distributors to reduce their profit range in order to keep the prices of the drugs low.
In the European countries, branded drugs were the only drugs that were sold and no one was purchasing the low cost drugs still the last year, but because of the financial crises and lot of publicity from the low cost drugs manufacturers, the increase in the sale of low cost drugs and decrease in the sale of the branded drugs is noted. But, the main concern for everybody is that even the low cost drugs sale in not up to the mark because consumer is not pertaining to the buy more medicines. This decline is observed in the entire world in the sale of the medicines and thus the financial crises are making the condition are hitting the pharmaceutical industry badly.
- Remove the old tub from the bathroom. Use the screwdriver to help remove faucets and the overflow shroud. Use the utility knife to cut away old silicone. The drain wrench is used to remove the old drain. You will probably have to remove all or part of the wall above the tub, as the wall covers the flange on the tub.
- Inspect the ledger boards that the rim of the tub sits on. If these boards look water-damaged or are showing signs of rot, replace them. The ledger boards help to support the tub when it is full of water.
- Inspect the p-trap that the drain attaches to. If it looks like it is in good shape and not showing signs of degradation, then it can be reused. If it does not look good, replace it at this point. Be sure to replace it with another p-trap, otherwise sewer gasses will continually invade your bathroom.
- Install the new tub, taking care not to damage the porcelain finish. Check for level, both back to front and left to right. Use the plastic shims as needed. Once the tub is level, attach it to the wall studs with the stainless steel screws.
- Install the drain and overflow assembly, according to manufacturer’s directions. Use the drain wrench to install the new drain, taking care not to over tighten the drain, as this could damage the tub.
- Install the new walls. How this is done depends on the type of wall surface chosen. Once the walls are finished, you can install the new faucet and spout.
- Download a template that best suits your flyer needs. Click on the image of the template you have selected, and click “Download” to begin customizing your flyer. Templates are available for all business needs, including marketing, grand opening announcements, business news, product reviews, special events and sales. The text and graphics can be changed on all templates. Make your selection based on the background designs and layouts you prefer.
- Edit the text boxes of the flyer. Double-click inside the text box to edit the text. Write your own dialogue to customize the flyer for your specific needs or announcement. In some templates, you can also change the position of the text boxes by dragging them. Delete any text boxes you won’t be using. Insert your business name, phone number and contact information.
- Insert your company logo or graphics. You can insert pictures or files in an existing graphics box on the template. Ensure that the margins of the document are set so the entire flyer will print on the paper size you selected. Save your completed flyer to your computer or a jump drive.
- Identify the industry. Determine the code that corresponds to your industry by going to the North American Industry Classification System (NAICS) website under “Resources.” For example, if you are looking for information about corn farmers, the NAICS code would fall under the “Agriculture, fishing, forestry and hunting” section, and the code specific to corn farmers would be 111150.
- Get an overview of the industry. Look up trade associations online for your industry or find the “Encyclopedia of American Industries” in your local library. Your local library should also have other resources such as “Standard and Poor’s Industry Surveys” or the “US Industry and Trade Outlook.” These sources should help you determine the size of the industry in dollars, the history, leading companies, government regulations related to the industry and whether the industry is seasonal.
- Determine industry trends. Look up websites related to your industry on compete.com and compare their online traffic data. This will give you a general sense of which companies are leading the industry and what kinds of growth patterns they might experience in the future. Use a search-based keyword tool such as Google’s keyword tool to see how many people are searching for words related to your industry.
- Look up consumer data. Go to the Bureau of the Census website to find industry data related to consumers in different geographical regions in the United States. Include demographics such as age, income, sex, race, ethnicity and family status for your industry. For psycho-graphic information such as buying habits, taste and lifestyle patterns, go to Nielsen’s Clarita site under “Resources.”
- Identify the competition. You can look up information about all publicly traded companies by checking with the Securities and Exchange Commission website. Looking at the search results for the products in your industry will tell you who the online competition is. Any company that fulfills the needs of the consumers of your industry is a competitor.
CONCEPT OF PROCESS VALIDATION FOR PHARMACEUTICAL INDUSTRY
CONCEPT OF VALIDATION
According to GMP definition Validation is “Establishing documented confirmation which provides a high degree of declaration that a specific process will consistently produce a product meeting its pre-determined qualifications and quality attributes.”
Suitable and absolute certification is recognized as being critical to the validation effort. Standard Operating Procedures (SOPs), manufacturing formulae, detailed batch documentation, change control systems, investigational coverage systems, analytical documentation, development information, validation protocols and reports are integral components of the validation philosophy. The validation credentials provide a source of information for the ongoing process of the facility and are a resource that is used in succeeding process development or modification activities.
All validation behavior will incorporate a level of Impact appraisal to ensure that systems, services and products directly prejudiced by the testing have been recognized.
A revalidation program should be implemented based on routine apparatus revalidation requirements and on the modify Control Policy.
Types of Validation
Establishing documented evidence that a piece of equipment/process or system will do what it purports to do, base upon a pre-planned series of technical tests as defined in the Validation Plan.
When an existing process can be shown to be in a state of control by applying tests on samples at tactical points throughout a process; and at the end of the process. All data is collected concurrently with the accomplishment of the process until sufficient information is available to make obvious process reproducibility.
Establishing documented confirmation that a process does what it purports to do, base on review and analysis of chronological data.
Design Qualification (DQ)
The objective of the DQ is met during the design and commissioning process by a number of mechanisms, which include:
1. Generation of User Requirement Specifications
2. Verification that design meets relevant user requirement qualifications
3. Supplier consideration /Audits
4. Challenge of the intend by GMP review audits
5. Product Quality Impact Assessment
6. Specifying Validation credentials requirements from equipment suppliers
7. Agreement with suppliers on the performance objectives
8. Factory reception Testing (FAT), Site reception Testing (SAT) & commissioning procedures
9. Defining construction and installation certification to assist with Installation Qualification (IQ).
Installation Qualification (IQ)
IQ provides documented evidence that the equipment or system has been developed, supplied and installed in accordance with design drawings, the supplier’s recommendations and In-house requirements. Furthermore, IQ ensures that a record of the main features of the equipment or organization, as installed, is available and that it is supported by sufficient adequate documentation to enable satisfactory operation, preservation and change control to be implemented.
Operational Qualification (OQ)
OQ provides documented evidence that the equipment operates as intended throughout the specified design, operational or approved acceptance range of the equipment, as applicable. In cases where process steps are tested, an appropriate placebo batch will be used to make obvious equipment functionality. All new equipment should be fully commissioned prior to commencing OQ to ensure that as a minimum the apparatus is safe to operate, all mechanical assembly and pre-qualification checks have been completed, that the equipment is fully purposeful and that documentation is complete.
Performance Qualification (PQ)
The purpose of PQ is to provide recognized evidence that the equipment can consistently achieve and maintain its performance qualifications over a prolonged operating period at a defined operating point to produce a product of pre-determined quality. The performance specification will reference procedure parameters, in-process and product specifications. PQ requires three product batches to meet all recognition criteria for in-process and product testing. For utility systems, PQ requires the utility intermediate to meet all specifications over a prolonged sampling period.
The PQ documentation should reference standard manufacturing events and batch records and describe the method of sampling and testing to be used.