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Liquid Packaging Lines
An efficient, systematic risk based, quality system approach to documentation enables us to prepare protocols in the shortest time possible. We employ a pragmatic approach to protocol execution allowing us to fulfill all regulatory documentation requirements quickly and efficiently.
Tablet Packaging Lines
SMB work with all the major equipment suppliers to the pharmaceutical industry, and have developed solid relationships with these manufacturers in order to quickly obtain the information required to develop protocols for……
Vials & Ampoule Packaging
Looking at the customer's needs from all viewpoints: Engineering, Production, Quality, Validation, and Documentation to fully understand the expectations."
Process Equipment
…is available to develop Validation Master Plans to describe the activities, roles and responsibilities of all involved, and to identify where the process fits within the typical project lifecycle…
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Labelers, Marking & Inspection Systems
….assessment of systems to ensure that compliance with 21 CFR Part 11 is being observed, provide a comprehensive compliance analysis for inclusion in validation packages and develop specific 21 CFR Part 11 tests and challenges for inclusion in the qualification documentation….
Blister Packaging
……Integrating packaging equipment from diverse and often geographically dispersed manufacturers requires particular attention and a high degree of validation project management….
Products & Services
....develop each of the various aspects of Computer System Validation, including System Life Cycle Methodology. SMB is able to define, document and implement the process and testing of all the various aspects of a computer based control system/process, from its inception through its design, build and installation, and up to its eventual decommissioning….
Purified Water (USP, DI, WFI, etc.) and Waste Water Treatment Systems
SMB has validated various building utility systems and their controllers, including Purified Water (USP, DI, WFI, etc.) and Waste Water Treatment Systems…..
Validation of an HVAC System
...requires a thorough understanding of the facility design, and the purpose of each zone/room in the facility. What are the areas and zones in the facility? What are their classes? What area(s) does each particular Air Handling Unit (AHU) service?......
How it began!
Since the Mid-1970s, Validation considerations have played an increasingly dominant role in the manufacture and quality assurance of U.S. health care products. But the origins of validation in the United States goes back to 1906 when the Food and Drug Administration (FDA) was formed in response to, of all things…….
Cost Effective Qualification
Equipment qualification has become a significant cost factor in the purchase, installation and start-up of equipment in both the Pharmaceutical and Medical Device Industries. For some manufacturers, equipment qualification now represents nearly……
GAMP4
This model is provided to help explain the various phases of the lifecycle and requirements of each to both the system user and supplier and describe how SMB may help plan, produce and execute the various components of the lifecycle process.
Tablet Properties for Coating
The problems associated with tablet shape differ considerably, depending upon whether the tablets are to be sugar coated or film coated. In the case of sugar coating, problems can arise from the desire to produce a continuous smooth surface, which is easy to swallow; when coating….
Film Coating
The long times associated with sugar coating stimulated the Pharmaceutical Industry to investigate other materials as alternatives to sugar for coating tablets. A gradual change from sugar to film coating is now taking place in the industry. The advances in film coating have accelerated the rate……
Transient Fill Volume of Rotary Volumetric Gear Pumps
The objective of this paper is to explain the inherent fill volume inaccuracies associated with transient operating conditions prior to achieving an operating steady state when using liquid fillers equipped with rotary gear pumps.
Two opposing factors will be described that are inherent to the design of all gear pumps and the physical characteristics of ….
Nine Easy Steps
Validation is often seen as a necessary but costly and complicated exercise. It need not be.
Validation is not optional. The challenge is to reach a "Qualified" state in the most efficient manner. A balance much be reached between too much and too little documentation.
SMB Group presents the nine easy steps to validation.......
Articles courtesy of DBA PTY (www.navigategmp.com)
The following information has been provided courtesy of DBA PTY.
- Quality Improvement Form
- Regulatory Agency Inspections
- Freedom of Information
- Checklist of Validation of Dy Heat Sterilizer
- Printer Checklist
- Due diligence
- Rockwell talk
FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely
The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.
» Read full story
FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans
The U.S. Food and Drug Administration, in response to requests from the U.S. Centers for Disease Control and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test.
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FDA Rule Requires Bar Codes on Drugs and Blood to Help Reduce Errors
As part of a wide-ranging effort to improve patient safety, on Feb. 25, 2004, FDA finalized a rule requiring bar codes on the labels of thousands of human drugs and biological products. The measure aims to protect patients from preventable medication errors by helping ensure that health professionals give patients the right drugs at the appropriate dosages.
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Bar Code History
In 1932 an ambitious project was conducted by a small group of students headed by Wallace Flint at the Harvard University Graduate School of Business Administration. The project proposed that customers select desired merchandise from a catalog by removing corresponding punched cards from the catalog.
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A look at how one man's invention led to changes in drug packaging
Necessity, according to Irish author Jonathan Swift, is the mother of invention. Indeed, it was both necessity and motherhood that motivated David Wagner of Geneva, Ill., to invent a device to help his wife remember to take her birth-control pills.
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The Healthcare Compliance Packaging Council
The Healthcare Compliance Packaging Council (HCPC) is a not-for-profit trade association that was established in 1990 to promote the many benefits of unit dose blister and strip packaging -- especially its ability to be designed in compliance-prompting formats that help people take their medications properly.
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FDA Issues Final Report on Its “21st Century” Initiative on the Regulation of Pharmaceutical Manufacturing
Following the second anniversary of the launch of its Pharmaceutical Manufacturing Initiative, the Food and Drug Administration (FDA) today issued a final report that highlights specific steps the agency has taken and will take to develop and implement quality systems management and a risk-based product quality regulatory system.
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Talking bottle helps Afghans take their medicine
Medicine containers that talk and give instructions on dosing have been discussed for a long time, but the first systematic application of the technology has come from a somewhat unlikely the source - the US Army.
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The Push for Modern Manufacturing
Antiquated manufacturing processes cost pharma money-a fact widely known and accepted in the industry. At some facilities, rejected batches, rework, and lengthy investigations have become a way of life, and by some estimates can inflate production costs by as much as 10 percent. According to G.K. Raju, executive director of the Pharmaceutical Manufacturing Initiative at the Massachusetts Institute of Technology, manufacturing consumes an estimated 25 percent of drug company revenues.
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Unit-dose Packaging - More regulations may not be necessary
Most efforts to get pharmaceutical companies to convert from bulk or multiple-dose packaging to unit-dose packaging have involved government requirements, like when FDA started requiring unit-dose packaging for iron tablets to minimize the likelihood of an overdose.
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The Evolution of Parenteral Drug Packaging
Newer configurations and materials expand the options for packaging parenteral products.
Prefilled syringes are a fast-growing alternative to conventional glass vials and stoppers for packaging parenteral drugs (see “The Ins and Outs of Prefilled Syringes,” PMP News, May 2003). All prefilled syringes on the U.S. market to date are glass. New plastic alternatives may soon make this packaging approach possible for manufacturers of a wider range of sterile products.
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Chasing the Pharmaceutical Dragon
Bar codes on drug labels is a good idea-even better, put a barcode on every pill.
In February 2004, Health and Human Services (HSS) Secretary Tommy Thompson announced that the US Food and Drug Administration (FDA; Rockville MD, USA; www.fda.gov) would require barcodes on labels of thousands of drugs to protect patients from preventable medication errors and reduce costs of health care.
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FDA Releases Final Unit-Dose Bar Code Rules
The Food and Drug Administration released its final rules requiring bar codes on drug and biological products last week. With improved bar code tracking, the FDA hopes to reduce the number of preventable medication errors and reduce the cost of healthcare.
» Read full story
Milestones in U.S. Food and Drug Law History
From the beginnings of civilization people have been concerned about the quality and safety of foods and medicines.
In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans. Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848.
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Child Safe Packaging Group
Formed in early 1995, the Child-Safe Packaging Groups stated objective was to create a level playing field of testing for child resistance for all forms of packaging, reclosable and non-reclosable for potentially hazardous products.
Although there is as yet no such level playing field nonetheless the CSPG has registered a number of achievements through its various initiatives and as a result CR packaging now enjoys greater acceptance and increased market share than was the case four years ago.
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FDA Guide to Inspections of High Purity Water Systems
This guide discusses, primarily from a microbiological aspect, the review and evaluation of high purity water systems that are used for the manufacture of drug products and drug substances. It also includes a review of the design of the various types of systems and some of the problems that have been associated with these systems. As with other guides, it is not all-inclusive, but provides background and guidance for the review and evaluation of high purity water systems.
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Minimizing Cost and Use of Purified Water
Exploring Alternative Technologies and More Judicious Consumption of Water-for-Injection. The pharmaceutical industry is facing strong and growing pressure to reduce the cost of producing drugs. One universal way to do that is to cut operating expenses, lowering the day-to-day costs of doing business. Minimizing energy and utility usage can have a significant impact on the bottom line.
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