Caraco Pharmaceutical Laboratories, the US-based unit of Sun Pharmaceuticals, has initiated a recall of multiple lots of cephalexin capsules from the US market, according to a PTI report. Citing a notification by the USFDA, the report says that the recall of the 3,40,553 units of 500 mg and 1,13,677 units of 250 mg bottles is…
ISO Publishes Water Footprint Standard
Water is one of the world’s most precious – and lucrative – resources, and now preserving our “blue gold” just got easier thanks to a new ISO International Standard. ISO 14046, Environmental management – Water footprint – Principles, requirements and guidelines, will allow all kinds of organizations, from industry to government and NGOs, the means…
CDER’s Drug Shortages Program
Between the years 2005 and 2011 the number of new drug shortages quadrupled to 251, posing a significant risk to public health. President Barack Obama issued a directive to the FDA in 2011 to develop a plan to address the problem. In 2011 the U.S. Government Accountability Office provided testimony to the Committee on Health,…
OSHA Proposes $449K Fine for Chemical Company
A federal safety agency has proposed fining a Wisconsin company more than $449,000 for allegedly failing to adequately protect workers from hazardous chemicals. The U.S. Occupational Safety and Health Administration cited Fontarome Chemical Inc. of St. Francis for 23 alleged safety and health violations. OSHA initiated an inspection in December 2013 after the company allegedly…
Microbial Monitoring Programs for Non-Sterile Operations
I have been tasked with establishing and implementing a microbial monitoring program for our new non-sterile ISO Class 6 cleanroom that packages medical devices for terminal sterilization by gamma radiation. What resources are available to assist me? Microorganisms (bacteria, molds, and yeasts) found in cleanrooms in the air and on surfaces are viable particles that…
New Pentagon Policy Helps Combat Counterfeit Semiconductors
The Semiconductor Industry Association announces a newly finalized Department of Defense rule that reduces the risk of counterfeit semiconductor products being used by the U.S. military by implementing needed safeguards in the procurement of semiconductors and other electronic parts. The final DoD rule addresses contractor responsibilities for detection and avoidance of counterfeit electronic parts. Among…
Standards Updates and Discussions at ESTECH
Since launching its program to develop global cleanroom standards in 1990, the International Organization of Standards (ISO) has published ten ISO 14644 standards under the auspices of Technical Committee (ISO/TC) 209, Cleanrooms and associated controlled environments. The voting members of ISO/TC 209 represent 22 nations. The ISO 14644 cleanroom standards established airborne particulate cleanliness classes…
FDA Tackles Broken Generic Drug Application Process
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…