Quality Assurance Articles

Regulations such as 21 CFR Part 11 have been well understood (and implemented) by the industry for several years. However, for the first time, the life sciences industry is feeling the need to manage regulatory compliance across regulations on a risk-based approach. Often, there is one officer in the company who is charged with regulatory compliance, and this officer is keenly interested in mitigating risk proactively in a unified governance framework for the company.

As biopharmaceutical companies bring new products to market, they generally focus on clinical development, regulatory submissions, and preparation of the target market. Equally as critical is developing the product's commercial supply network. Thoughtful planning and design of the supply chain during product development significantly impacts not only the efficiency of commercial supply, but also the flexibility required to accommodate lifecycle changes. Ultimately, the right supply chain can help ensure the availability of critical and life-saving products to patients who need them. Conversely, an ill-planned supply chain can increase operating costs, restrict a company's flexibility, and constrain the flow of product to patients.

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"I was the new employee and needed some information," says our GMP Agent-in-Place. "Our company makes 300 products, and some products use common ingredients. We had to make a change in one commonly used ingredient and wanted to be sure that we had evaluated the effects for all the necessary products. Because I was new, I didn't know how to figure this out except by looking at all the , and I voiced this frustration to my boss. She told me to use the 'Gazinta Report.'

"So I asked several people for this report, and was given a six-inch thick computer printout. But when I looked at the title, it didn't say Gazinta, and I thought I had the wrong data. When I asked my boss again, she laughed and told me to read the name fast. Apparently, the original request for what is commonly known as 'where used' data was requested as 'what the ingredient goes into,' and the printout was titled 'Goes Into Report.'"

To keep their products free from moisture damage, nutraceutical manufacturers are using desiccant canisters, packets, and inserts in their packaging units. Applications include pharmaceutical, medical, nutritional, and diagnostic. Some packets are available in a continuous strip wound o­n a reel for automatic loading. Some provide early and visible warnings against possible humidity damage.Süd-Chemie Performance Packaging, Belen, N.M., offers desiccant products with a variety of desiccant fills: activated clay, activated carbon, silica gel, and molecular sieve.

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Drug shortages have been in the limelight in recent months, turning attention toward pharmaceutical manufacturing regulations and standards. FDA’s Web site, www.fda.gov, lists several therapies that are in short supply as a result of production problems and manufacturing difficulties. Limited access to routine vaccines for infants and children has public health authorities concerned. Pharmacists have stepped up tracking efforts because they cannot obtain important therapies in hospitals and clinics. The drug shortage situation has prompted FDA and other health authorities to examine the underlying factors of this troubling development. o­ne potential cause being discussed is whether stricter FDA enforcement of good manufacturing practices (GMPs) standards and new production rules is forcing companies to close or upgrade plants or discontinue production of low-profit medicines.

The quest for “pure” water chemistry.


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In a regulated laboratory, both instruments and methods must be validated to be suitable for their intended purposes. It is equally important, however, that personnel are properly trained and qualified for the task at hand. But in spite of this requirement, FDA still frequently cites firms for a lack of trained personnel. This month’s “Validation Viewpoint” examines how instrument vendors can ease the burden of training for GMP compliance.


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Rarely do manufacturers of biologics need to prepare a Biological Product Deviation Report (formerly called and Error and Accident Report); in fact, few manufacturers ever have to complete o­ne. But all manufacturers need to have an SOP describing how to complete this report, in case it becomes necessary.

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Janet Rose Christensen
BioPharm International, November 2004 Good manufacturing practices (GMPs) are manufacturing guidelines for ensuring the safety and efficacy of drug products and medical devices. The GMPs are legal regulations, based o­n the United States Food, Drug and Cosmetic Act. But, why do we need the GMPs? Shouldn't we, as knowledgeable individuals, groups, and companies, be able to figure out how to produce drugs and devices that are safe and effective?

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The future is now for manufacturers of Active Pharmaceutical Ingredients (APIs) with the publication of the Q7A Guidance for Good Manufacturing Practice. San Juan, Puerto Rico was the site for a comprehensive workshop, sponsored by the Parental Drug Association (PDA), Generic Pharmaceutical Association (GphA), Pharmaceutical Research and Manufacturing Association (PhRMA), and the U.S. Food and Drug Administration (FDA). This workshop had two main goals: to introduce the basic concepts of the Q7A guidance, and to offer a glimpse of the rationale and intent of the designers of the document as it applies to API.