Today nearly 84 percent of all prescriptions filled in the U.S. are generic. The generic industry’s trade group, the Generic Pharmaceutical Association (GPhA), has released figures that show the impact of generic drugs: over the last 10 years, generic drugs have saved consumers in excess of 1.2 trillion dollars. At the same time, the FDA…
Document Management
The ISO 9001:2008 Clause 4.2. Documentation Requirements defines all documentation as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems, and the level of communication skills within the organization, and the organizational…
Practical Application of Rapid Microbiological Methods to the USP <1116> Contamination Recovery Rate Approach
The past year has seen a change in the way pharmaceutical manufacturers monitor their aseptic environments with the most recent revision to the guidance chapter <1116> in USP 35/NF 30, now entitled “Microbiological Control and Monitoring of Aseptic Processing Environments.”1 One of the major changes within this chapter is guidance for the assessment of contamination…
Quick Guide to Internal Audits
Internal audits should cover the full spectrum of a company’s processes and be designed to close the loop between industry standards, customer specifications, and the company’s people, processes, and product. [video:http://youtu.be/UQHrANk4O7g]
What Do the New Sterile Compounding Pharmacy Regulations Mean to You?
Congressional Bill of the 113th Congress. H.R.3204 – Drug Quality and Security Act. “To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.” The fact is, no one really knows just yet what the new law will mean. However, be assured…
FDA’s Proposed Change in Generic Drug Labeling
In November 2013 the FDA put forth a proposed rule allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in product labeling.1 This would speed the dissemination of new safety information about generic drugs to health professionals and patients. FDA’s Proposed Rule2 would allow generic manufacturers to…
Guide to Meeting New USP Changes
Pharmaceutical manufacturing companies have been nervously awaiting the fallout from major modifications in the U.S. Pharmacopeial Convention’s (USP) Chapter 411 minimum quality standards for weights and balances. The Chapter 41 standard, previously used in assays to determine drug content and potency, was last updated more than twenty years ago. A global team of experts drafted…
FDA’s Initiative on Breakthrough Therapies
The FDA is the regulatory gatekeeper for every drug sold in the U.S. But there is growing recognition at the FDA, in industry, and among patients’ groups of the serious risk of the agency falling behind in its core responsibility of evaluating new medical products in a timely and predictable manner. Without an FDA that…
Cough Syrup Recalled Over Contamination Fears
Novartis Consumer Health U.K. Ltd. has been alerted to a potential manufacturing fault with the tamper seal on some Tixylix liquid medicines, which might result in small pieces of plastic being found in the medicine. This potential defect only affects specific batches of Tixylix manufactured from October 2012 onwards and as a precautionary measure these…
FDA Issues Stern Warning on Med Devices
Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death. Medtronic Inc. announces that the FDA has classified the company’s recently initiated voluntary field action related to certain guidewire. Based on an internal investigation following a limited number of complaints,…
International Certification of Cleanroom Training Courses
As usual, the Romans were able to sum it all up in a short and pithy aphorism: “Quis custodiet ipsos custodes?” The phrase, attributed to the poet Juvenal, is literally translated as, “Who will guard the guards themselves?” but is frequently expressed as, “Who will watch the watchmen?” The phrase readily springs to mind as…
Audit for Compliance
One of the steps to prepare for a successful second party customer audit or a third-party registration audit is to conduct several first-party internal audits. Establish a cross-functional internal audit team and train them in the company’s audit procedure, policies, and specific elements of the standard relative to the third-party certification. The internal audits conducted…
Performing a Clean Zone Smoke Test
As a Registered Cleanroom Certification Professional, I have seen an increase in the use of “clean zones” inside of cleanrooms in pharmacies. There are numerous types of unidirectional-flow devices that have been used in the past; however, when using a unidirectional-flow device in the compounding processes, the suppliers, customers, and certifiers need to keep in…
Facility Harmonization Challenges for the Global Marketplace
The pharmaceutical market today can be considered a true global marketplace. While the U.S. remains the largest market in the world, the emerging markets are growing rapidly and narrowing the gap, with China to become the second largest pharmaceutical market by 2015. In this global expansion, companies are building facilities with the intent of supplying…
OSHA Voluntary Program Recognizes Effort
Q: What is the OSHA Voluntary Protection Program (VPP)? Is it applicable to cleanrooms and other controlled environments? A: Yes, the Voluntary Protection Program is applicable to cleanrooms and other controlled environments. The VPP recognizes operations that have implemented effective safety and health management systems and maintain injury and illness rates below the national average…
Certified Control of Cleanrooms
Construction is just the beginning of the process of getting a cleanroom operational. The next step is certification. Why is it important, how is it done, and who regulates it? The National Environmental Balancing Bureau (NEBB) is an international certification association whose members test and certify cleanrooms. Founded in 1971, the not-for-profit organization develops standards,…
Toward a Revised International Cleanroom Standard
A proposed new version of the international cleanroom standard ISO 14644 Part 1 was issued as a draft international standard in 2010. The draft received such an unprecedented level of comments that the committee tasked with overseeing the standard withdrew it. An indication of what the new draft is likely to contain is provided from…
New Weapon to Fight Falsified Drugs
The European Commission took a big step forward in protecting the interests of ethical drug manufacturers and the safety of the public with its Falsified Medicines Directive 2011/62/EC. There is an important distinction to make: Falsified drugs are not counterfeit drugs, which often contain no active ingredient at all. Rather, falsified drugs may contain substandard ingredients, or…
Exposure Limits Resolved
Regulation of exposure to chemicals in the United States has become a topic of speculation.1 Certainly, this column has contributed to thecacophony. On March 20, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) finally released the long-in-the-making revised Hazard Communication Standard (HCS). The fundamental problem It’s expensive to produce valid and accepted…
Going Retro
Q: My decade-old facility has never been commissioned and I’m suspecting some operations, energy, and cost issues are lurking. Can you guide me through a retro-commissioning process? A: The old saying, “What you don’t know will kill you” applies perfectly to managing existing facilities. Clean manufacturing facilities with their additional layers of complicated building and…
Hazards Communicated!
Where were you when the MSDS was “born,” nearly 30 years ago? Since that time, particularly over the last decade, various regional or national regulatory agencies have undertaken the task of classifying chemical hazards, rendering those classifications not only more important but also more consistent with others worldwide. In some cases, these independently developed classifications…
Please help us determine the source of the silicone contamination.
Recently, our cleanroom became contaminated with silicone. Contamination with silicone is a very serious problem in our industry. Please help us determine the source of the silicone contamination. Silicone contamination is a serious problem in the semiconductor, microelectronics, defense and automotive industries internationally. Silicone becomes aerosolized inside the cleanroom and as an airborne molecular contaminant…
VOC Emissions from Cleanroom Materials
In addition to particle generation due to mechanical stress, the outgassing behavior of materials considered suitable for use in cleanrooms is becoming an increasingly important factor. First, the quantities of substances emitted from the materials deemed suitable may not exceed statutory maximal allowable workplace concentrations (MAC values). Second, sensitive manufacturing environments require a controlled low…
Effective Training Solutions – An End-to-End Success
When Singapore-based STATS ChipPAC, Ltd., a leading semiconductor manufacturing solutions provider, needed to rapidly launch a critical new growth product, executives, managers, and trainers were confident that teamwork would help get the job done—but they also knew that teamwork alone would not be enough. Executive leadership had already hired brandnew management, supervisors, engineers and operators.…
Exposure Limits: Should We Take the Bypass?
Exposure limits are crowd-sourced, sometimes based on incomplete data, and often not developed within public view. Inevitably, as science, they are imperfect. But as metrics they have been benchmarks which have empowered environmental progress and provided a means for assessing that progress over the last several decades. GOVERNMENTAL POWER Both welcomed and feared, the power…