They did this to support their international presence and recognition. The information on food packaging must specify the name and address of the manufacturer or distributor. Your city and town, plus state, should be mentioned there as well. Packaging will be considered radiation if it has: There are laws about putting labels on your food packaging. All written comments should be identified with this document's docket number: FDA . The US Food and Drug Administration (FDA) on Tuesday finalized guidance on child-resistant packaging (CRP) statements that should be included in the labeling of prescription and over-the-counter (OTC) drugs. We will cover industries like food, electronic devices, and general labeling. The manufacturers should have procedures to reconcile any discrepancies in quantities of the drug versus the quantity of the labeling produced. The design of the package or the barriers should be distinctive. Manufacturers can request an exemption from this requirement if they believe the requirements are unnecessary, cannot be achieved, or alternative measures can be taken to ensure safety. Our website is compatible with many popular payment methods. This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market. Make sure that your medicine packaging contains information about who can use them and when. Regulatory News | 30 July 2020 | ByKari Oakes, Regulatory Affairs Professionals Society (RAPS) Welcome to our new website! Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations) was first issued in August 2006. INTRODUCTION. FDA food labeling requirements do not require any kind of durable life labeling for products, except for infant formula. You should always offer nutrition information for your food product. FDA provides regulatory and scientific information about irradiated food and packaging. Rich Hollander, manager of packaging services for Pfizer, Inc., New York, NY, says, "The document does a lot of great things, such as making it easier to switch film . Let Your Packaging and Labeling Be in Compliance With FDA. These "Food Defect Action Levels" listed in this booklet are set on this premise--that they pose no inherent hazard to . FDA: Packaging Implications in the New API Guidance The FDA released a Q&A-style guidance that clarifies many facets of good manufacturing practice for API production and distribution throughout the supply chain, with mention of relabeling and outsourcing of process steps. Labeling of each drug product should be stored separately and identified appropriately. That is the upshot of the Nov. 19, 1999, FDA guidance, which sorts "post-approval" packaging changes into levels of concern and assigns notification requirements for each. Nutritional labels must be printed in all black or one colour type on a white or neutral contrasting background and must be readable. The July 2021 update includes "Paperwork Reduction Act information and non-substantive formatting . We will discuss FDA food labeling requirements for the US market and the Health Canada food labeling regulations for the Canadian market. However, if you want to reach the customers, you need to ensure that the packaging complies with all the existing laws and regulations on your targeted market. Check out the Member Knowledge Center for free webcasts, publications and online courses. When companies think about food packaging, it is usually focused on making it attractive and enticing the customers to buy the product. Also, adults who may have efficacy can use the product. FDA maintains educational information, databases and listings related to food allergens, ingredients, food additives, color additives and GRAS substances. Make sure that you also offer your packer or distributors information here, like their name and address. In addition, they should clear any chance of label mix-up before the labeling process starts. Taking a small number of cells from living animals and growing them in a controlled environment to create food is an emerging area of food science. The results of these inspections and examinations should be documented in the batch production record. If it carries radiation, your packaging should carry the information consumers need to know about the radiation source. has Certified Gluten Free on it, to avoid any confusion. As such, a sample of the packaging should be collected and visually inspected, and the results should be recorded in the batch control or production records. FDA also takes care of compliance with their drug packaging and labeling guidelines. In Canada, it can be located anywhere on the packaging. 51 W 3rd St View on Google Maps #265 Tempe, AZ 85281 (480) 829-7396. Guidelines on packaging for pharmaceutical products Introductory note 120 Glossary 121 1. The drugs can be used for both adults and young kids. Rockville, Maryland 20852, 2023 These US FDA packaging requirements ensure that your customers get the best products with the best information. Adding the manufacturers name to the label is a must as well. If your x-ray tubes are creating x-radiation if a source has a voltage of 500. Principal display panel (PDP) is a surface that is most visible to the consumer on the shelf or at the time of purchase. With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industryPurpose:Ensures the packaging of safe and effective product in an efficient manner. In addition, such packaging essentials allow them to look for the products that go with their health and any health issues. Make sure you mention your products sterile part in the labeling process. *NEW* CFSAN Online Submission Module (COSM), Better understand genetically engineered foods(GMOs). Also, note that in Canada, there have been food labeling changes regarding the list of ingredients and nutritional information for which CFIA will verify compliance as of December 15, 2022. Drug packaging should also have an appropriate expiration date as determined by stability testing. If this is the first time you are logging in on the new site, you will need to reset your password. Strict controls are in place for labeling issued in drug labeling operations. So you can make the right decisions and offer the information these laws bound you with. Other mandatory pieces of information must exist here, like it should carry the manufacturers name and address. However, we want to make sure that you are aware that those differences exist. Keren Sookne Apr 26, 2018 The laws are clear about how you should mention different information on your package labeling. Please contact us at raps@raps.org if you need assistance. Radiations in food packaging can make an impact on your food; FDA has set laws for it, like. The FDA is strict about this aspect and takes full care of making things easy for customers in this section. Poultry, alcoholic beverages, and meats are not part of labeling restrictions in terms of allergens. Packaging for over-the-counter drugs is also specified in 21 Code of Federal Regulations Part 211, Subpart G. Per Code of Federal Regulations Part 211, Subpart G, all over-the-counter drugs should be in tamper-evident packaging. There are certain products that are exempted from these regulations, so make sure that you have all the relevant information regarding your product before designing and printing food packaging. Clearly mention any conditions in which you should use the drug. Aspects of packaging 125 1.1 General considerations 125 1.2 Functions of packaging 127 . There is no equivalent standard in Canada. An exception to this rule is when the product undergoes a substantial transformation in the USA. You should update the products information about a certain drug when new updates are available. Any materials meeting the requirements may be approved, whereas those that do not may be rejected. Celiac disease is one of the most common allergies in the United States. Order your stylish and durable custom boxes and packaging from a team of industry experts. A Guide on FDA Packaging and Labeling Requirements. What Are FDA Food Packaging Label Requirements? Specify procedures for examining packaging and labeling for suitability and correctness before packaging operations inspection of the packaging labeling facilities before use to determine that materials from other drug products have been removed. We have some top US FDA packaging requirements you need to comply with. Unit-dose repackaged oral solid medications will generally not be subject to US Food and Drug Administration (FDA) action regarding nonconformance with expiration date provisions, so long as certain requirements are met. Generally, solid foods are measured by weight and liquid foods in uid ounces. A brand must ensure that they test all the labels before their use on the product packaging. Nearby Dining. For instance, they must start with calories and end with potassium. Our success, in large part, has been down to our key ethos, which our Machines are designed around; 'flexibility, simplicity and durability'. We also regulate how most food is processed, packaged, and labeled. Responsible individuals must keep in mind that they should keep the labeling area safe from any label mix-up. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies. FDA Packaging Guidelines For Drugs FDA also takes care of compliance with their drug packaging and labeling guidelines. The characteristics that make the packaging tamper evident, such as a sealed cap, should be identified on the label. In short, there is no chance of you getting away if you do not follow the best practices. Radiation Guidelines in Food and Packaging. FDA provides regulatory and scientific information about irradiated food and packaging. These indications must go with the results of any studies conducted over groups for use. Make sure that your net quantity appears in a red box in the principal display panel. Other rules apply to your product packaging, like you can mention Fluoride next to Sodium. These food packaging guidelines can help everybody who is involved in creating food packaging to make sure that the packaging complies with the regulations. Per FDA regulations, pharmaceutical packaging must: Provide protection against exposure to light, moisture, oxygen and variations in temperature as each of these can adversely alter the medication's quality. Gang printing of labels is not allowed unless the labeling of the sheets is distinguished by size, shape, or color. A company that does not pay attention and budget to avoid any label mix ups will definitely have compliance issues. For instance, they should have information like nutrients in a certain order. The .gov means its official.Federal government websites often end in .gov or .mil. It is a must to make sure all of your labels follow the specific information you need to convey to them. Both countries requirements regarding the manufacturer identity statement are more or less the same, although Canada has more specific wording requirements for the products manufactured in other countries. Net quantity is the amount of food in the food packaging. Foods produced from genetically engineered plants must meet the same food safety requirements as foods derived from traditionally bred plants. In the USA, you should put nutritional information on the PDP or information panel whenever possible. FDA Food Packaging Requirements For Nutrients, The Usage and Indications Section For Drugs. In response, the committee enlisted a cross-functional team to 1) seek guidance from similar, well-established industry standards or practices (e.g., International Medical Device Regulators Forum or IMDRF) and 2) formally solicit feedback on packaging process validation from drug manufacturing industry leaders and peers by way of an ISPE . Your food products must contain nutritional facts about them with a certain hierarchy. This is the same both for FDA food labeling requirements and Health Canada regulations. There have been changes in the FDA food labeling requirements regarding nutrition facts, and the transition period has ended on January 1, 2021. intended to contain and protect a drug and is or may be in direct contact with it. Such information allows them to learn about different aspects of the products ingredients. Your customers should know what part of your product is sterile. However, the FDA strongly supports eorts to include a best if used by phrase to help reduce unnecessary food waste. Their rules state that your packaging should be precise to offer quick information about your product. Continuously improves production operations by performing any . Containers must be well closed and remain airtight if repeatedly reopened/closed. Manufacturers should destroy any excess labeling that has lot or control numbers. Also, you should specify if a medicine will work for a particular disease and what it will do against it. Also, you should mention user instructions when you use and store the products. A responsible person must check them before they are used on the containers. The owner and its contributors will not be liable for any losses, injuries, or damages from the display or use of this information. The USA have no rounding requirements but must not exceed two decimal places. Gluten-free labeling laws make sure such mishaps do not occur. There are also bi-lingual French-English and Spanish-English GFCO marks. You should also mention the foods name and give an identity statement there. Access program information, inventories, and databases related to food packaging and other substances that come in contact with food. FDA assesses the environmental impact of its regulatory actions. These are the most common FDA packaging and labeling requirements you should meet in the concerned industries to ensure you comply with the laws. The area panel on the immediate right of the PDP is the Informational panel. Labeling materials should be carefully inspected to determine that they are correct and that they conform to the labeling specified in the master batch of production records. National Bioengineered Food Disclosure Standard, Information about manufacturer, packer and/or distributor, Information about primary business or dealer, Storage instructions (If food is not to be stored at room temperature), Food served in a restaurant or similar establishments and, Packaging of any kind should not be included when determining the net quantity. However, other required information can be placed anywhere on the packaging and they include: Canadian regulations require bilingual information and a best before date which is not mandatory in the USA. It must be given in weight, measure, or count. Aug 12, 2022 Maja Mandic These food packaging guidelines can help everybody who is involved in creating food packaging to make sure that the packaging complies with the regulations. This information is mostly essential for them to make educated and right decisions about the products they choose and use. Allergens are one of the biggest concerns for regulatory authorities in many countries. In 2020 GFCO introduced a redesigned Gluten-Free Certification Organization (GFCO) mark. On the website, they can search for certified gluten-free products. So, food packaging and labeling mention this ingredient in packaging to ensure that patients do not accidentally consume this ingredient. Several available disclosure options are: Common name (ice cream, sandwich) must be visibly displayed with the format of the food (if there are different formats available on the market). These points work as an FDA food label guide for packaging companies and firms in this space. Then get your free quote today! Some elements they should carry are. Process, We hope that these food packaging guidelines will help you know what to pay close attention to when creating food packaging for your products. The company should ensure using a system for any changes in labeling. F. D. A. You can not claim your product to be gluten-free if it does contain refined grains with this ingredient. Your product should carry information about the maximum radiation emission from your x-ray tubes. It is permitted to use imperial units, but it is not required.. This package should have at least one barrier to entry that could indicate to consumers whether someone tampered with . The Food and Drug Administration has the authority under the Federal Food, Drug, and Cosmetic Act (the act) to establish a uniform national requirement for tamper-evident packaging of OTC. Moreover, it should talk about scientific evidence perfectly. These principles result in a unique machine . New revised leaflets now clearly state that Plan B and its kin work "before release of an egg from the ovary . Title 21, Code of Federal Regulations, Part 110.110 allows the Food and Drug Administration (FDA) to establish maximum levels of natural or unavoidable defects in foods for human use that present no health hazard. Using instructions about how you can avoid contaminations in the device may be mentioned on it. It is better to avoid any labeling over an existing label. Ensure that you check all expiration dates on these labels. Mentioning such information on your food packaging allows your customers to make educated decisions about what they consume. Using short names of ingredients is allowed. Before sharing sensitive information, make sure you're on a federal government site. Certain general requirements make labeling super important for any manufacturer or packaging firm. Outdated labeling should be destroyed. Packaging for over-the-counter drugs is also specified in 21 Code of Federal Regulations Part 211, Subpart G. Per Code of Federal Regulations Part 211, Subpart G, all over-the-counter drugs should be in tamper-evident packaging. A product can not claim to be gluten-free if it carries more than 20 ppm of gluten. For instance, a medicine can be for specific prevention or maybe for treatment. If a drug is for pediatric patients (young kids) may be for only their population. Records should be kept for any shipment of packaging that is received, regardless of whether it is approved or rejected. Manufacturers should provide written instructions and procedures regarding the examination and handling of materials. Well, your labeling needs to follow the laws that significantly affect your packaging. Where can a consumer find the FDA food labeling guide? Offer the company name and address if the city directory does not have the address. The FDA Group, LLC and its contributors will not be liable for any errors or omissions in this information nor for the availability of this information. Here are some points to keep in mind for better compliance. So, your drug label should contain this information accurately. For instance, you can not consume gluten if you have celiac disease. So, you should mention age groups with the use of a drug. You can read about food and general laws that the FDA or Food and Drug Administration imposes on manufacturers. Make sure that your packaging delivers information that healthcare practitioners can understand. Since there are many differences between the two countries and many rules regarding ingredients, we will not go into details in these food packaging guidelines. You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852. 5635 Fishers Lane, Suite 400 And we help you get the right packaging and labeling that your customers will love to rely on. However, on Friday the U.S. Food and Drug Administration removed language on implantation from the pills' packaging and instead added language that explicitly states that the pills are not abortion drugs, the New York Times reported. The closure is a part of the container. 2011 . If any labeling or packaging is returned, manufacturers should store it in a manner that will prevent mix-ups and enable correct identification. The net quantity must be rounded to two figures in Canada if it is less than 100 units, or three if it is more than 100 units. While the complexities of shipping validation remain, the Compliance Group team and Polarion ALM can assist your teams with determining the appropriate risk-based, phase-based . The inclusion of the gfco.com website on the mark directs consumers to the GFCO website. RAPS Headquarters will be closed for the end of year holiday from 26 December 2022 through 2 January 2023. Packages and labeled drugs should be examined during finishing operations to ensure that packages and containers have the correct labeling. Free Whitepaper Packaging for the future: embracing circularity and reducing costs You should also give your ZIP code on the packaging. As manufacturers of pharmaceutical products, pharmaceutical executives must know the appropriate guidelines governing the manufacture of packaging and labeling. You may need the expiry date mentioned on the device if any of the parts have limited-time use capability. Health Canada closely regulates the size and appearance of the NFT. These tips show FDA food packaging guidance that you should follow entirely. You should ensure your names present on every container you send to your customers. The container Are you an American manufacturer working in the food or another industry? Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey. Want to order custom packaging and boxes for your products? This article offers a general overview of the food labeling regulations in the USA and Canada and the main differences between regulations in these two countries. Aug 12, 2022 Updated: Dec 28, 2022 Maja MandicFDA Food Packaging Guidelines for 2022. Provide technical training and guidance. Search for FDA Guidance Documents. Please see our Privacy Policy for more information. It should carry the contents net quantity. These requirements are stated in 21 Code of Federal Regulations Part 211. FDA provides regulatory and scientific information about irradiated food and packaging. The US ingredients list has to be located on the PDP or Information panel, together with the information about the manufacturer or distributor. Minimal type size depends on the total area of the PDP. Either you can declare the allergen in parenthesis or add a Contains statement at the end of the ingredients list. Food labeling helps consumers learn about the product and helps them make decisions to choose the most appropriate products for them. Packaging materials are considered an "indirect food additive;" see 21 CFR parts 174-178 . Food & Drug. Irradiation may be used to increase shelf-life and reduce harmful bacteria in meat, poultry, vegetables. Address. In the News. Therefore, manufacturers must include an environmental assessment with their petitions and notifications, unless exempt. Even though FDA does not require country of origin information to be on the label, note that USA Customs and Border Protection does. The barriers should have an identifying characteristic, such as an identifying name or logo, and the labeling should include a prominently placed statement that identifies the tamper-evident features and any capsule-sealing technology used. This standard defines bioengineered food as food containing modified genetic material that could not be obtained through conventional breeding or found in nature. The Packaging Hub ensures that you get packaging and labeling in compliance with the American food and drug authority. It is important to note that it is not possible that the same Nutritional Facts panel can satisfy both FDA food labeling requirements and Health Canada food labeling regulations. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. If the medicine is effective for a certain pediatric group, your consumers may use it for other subgroups in the same group. The type size is determined by measuring the lowercase o. In the USA, net quantity has to be printed in both US Customary and metric measurements., In Canada, the net quantity must be expressed in metric units in both French and English. Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices. The labeling may contain a certain broader group who may use them. FDA regulates the safety of substances added to food. We wish everyone warm Seasons Greetings! These rules need to be taken care of strictly as they can cause serious health conditions for individuals with celiac disease. You can mention your sub-ingredients following the ingredients common name. Their rules state that your packaging should be precise to offer quick information about your product. The U.S. Food and Drug Administration (FDA) has updated its guidance on the use of recycled plastics in food packaging. "This testing protects against factors such as the transport and aging of the packaging material itself, which could weaken over time and expose the contents to pathogens." "Packaging must undergo a spectrum of validating tests to demonstrate their ability to withstand environmental factors. It is essential to mention all the allergens that a product may contain. Also, note that starting January 1, 2022. theNational Bioengineered Food Disclosure Standard is effective in the USA. However, you should use these food packaging guidelines for informational purposes only, as some foods are more heavily regulated than others, and regulations are subject to change. E-mail address & Password Combo is invalid, ICH releases draft guideline proposing harmonized bioequivalence testing, Marks says evaluating T cell immunity for future COVID vaccines makes sense, ICH touts adoption of continuous manufacturing, safety reporting guidelines, Recon: FDA approves first FMT drug; Pfizer plans $1.26B Dublin expansion, Fundamentals of Medical Device Regulations, Fifth Edition, Postmarket Requirements for Medical Devices: A Practical Guide (e-book), 2022 NMPA (CFDA) Key Updates and Look Ahead (On-Demand), RAPS Webcast: Streamlining Conformity Assessment in Device Submissions: FDAs ASCA Program (On-Demand), Preparing to Take the RAC Drugs Exam (May 2023). Proprietary talent selection of former FDA and industry professionals amplified by a corporate culture of responsiveness and execution. A second consideration with respect to packaging is whether the container may cause the food to be adulterated. If your product mentions and claims not to use gluten without meeting the requirements, it will be considered an act of misbranding. Also, it should have relevant terms for such professionals and the industry. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Consumer Information on Ingredients & Packaging, Overview of Food Ingredients, Additives & Colors, Determining the Regulatory Status of a Food Ingredient, Packaging & Food Contact Substances (FCS), Human Food Made with Cultured Animal Cells, Ingredients, Additives, GRAS, and Packaging Guidance, Code of Federal Regulations Citations for Color Additives, Food Ingredients, and Packaging, All Ingredients and Packaging Inventories, Substances Added to Food (formerly EAFUS), Effective Food Contact Substance Notifications, Inventory of Food Contact Substances Listed in 21 CFR. Why do you think the FDA requires some products to have an as prepared label? Also, ensure you offer any information about subgroups that can use the medicines. The seven-page final guidance comes two years after FDA released the draft version for comment. meets both the USDA requirements and international trademark registration requirements. Only the product that does not contain gluten will be labeled as gluten-free and vice versa. This way, you can communicate the latest usage and indications of any drug containing labels. Provide protection against physical damage through . Make sure that you waste all the extra labeling tags and that they never reach the labeling area at any time. There is certain required label information that must be printed on the two panels mentioned above.Common name and net quantity must be printed on the PDP panel and the Informational panel.. Subpart G of these regulations includes the criteria for examining and using materials, issuing labels, using tamper-evident packaging for over-the-counter drugs, conducting packaging and labeling operations, inspecting drug products, and assigning an expiration date. For instance, you can have a label on the front panel or principal display panel. The rebranded mark:. For many years, Plan B One-Step and its generic equivalents -- collectively known as "morning after" pills to prevent a pregnancy Welcome to FDA Packaging. Irradiation may be used to increase shelf-life and reduce harmful bacteria in meat, poultry, vegetables. We will respond to all questions upon our return. RAPS.org needs your explicit consent to store browser cookies. FDA issues new unit-dose repackaging guidance Regulatory News | 30 July 2020 | By Kari Oakes Unit-dose repackaged oral solid medications will generally not be subject to US Food and Drug Administration (FDA) action regarding nonconformance with expiration date provisions, so long as certain requirements are met. When companies think about food packaging, it is usually focused on making it attractive and enticing the customers to buy the product. Only authorized personnel should have access to the area where there are being stored. Your labels should carry certain information and follow the guidelines. Companies had until 2022 to completely adopt the new symbol on the packaging. Home Blog A Guide on FDA Packaging and Labeling Requirements. The site is secure. This package should have at least one barrier to entry that could indicate to consumers whether someone tampered with the drug. You must store packaging material, inserts, or containers in an area that does not cause any labeling mix-ups. Make sure that your packaging delivers information that healthcare practitioners can understand. Your membership opens the door to free learning resources on demand. ACM Research stock rallied 30% Tuesday, putting it on track for its biggest one-day percentage increase since March 6 of 2018, after the company backed revenue guidance for 2022 and set guidance . Make sure your packaging labels list all ingredients the product carries. Multiple formats can be used, and the choice depends on the precise calculation of the Available Display Surface. There is aList of bioengineered foodsfor which disclosure is necessary. Packaging Guidelines in 21 Code of Federal Regulations Part 211, Commissioning, Qualification, and Validation. Printers should be monitored to make certain that the print matches that specified in the batch record. By knowing what the guidelines for packaging are, pharmaceutical executives can ensure that their facilities are manufacturing labeling and packaging that complies with the regulations. The label can have certain limitations only if an FDA expert is concerned about the drug or there is any risk of issues with the product. The Center For Drug Evaluation and Research of the US Food and Drug Administration (FDA) has issued new guidelines for test batches packaging for abbreviated new drug applications (ANDA), abbreviated antibiotic applications (AADA) and supplements. Details. Established in 1992 we have many years experience in Flow wrapping machines in the UK and worldwide, with many repeat customers. They have guidelines for every industry that makes their resources comprehensive and accurate for every professional packaging and labeling need. And this is why the American government is taking stringent steps to avoid any gluten consumption mishaps by such patients. If you are a manufacturer of gluten-free products, it would be useful to check their Branding Standard and Certification Scheme Manual. These FDA food labeling requirements make it easy for your customers to understand why food packaging needs a lot of attention and vigilance. Regulatory Affairs Professionals Society. 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