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Editorial: Current Good Manufacturing Practice (cGMP) Regulations, Part 4
In continuing our summaries of Current Good Manufacturing Practices (cGMPs), we will cover "Subpart B: Organization and Personnel" this week.
B. Organization and Personnel
Responsibilities of Quality Control Unit
The quality control unit has the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products; it also has the authority to review production records to confirm that no errors have occurred or, if they have, that they have been fully investigated. The unit is also responsible for approving or rejecting products manufactured, processed, packed, or held under contract by another company. This unit must have adequate laboratory facilities for the required testing and approval; it also has the responsibility of approving or rejecting all procedures or specifications impacting the identity, strength, quality, and purity of the drug product. All the requirements and activities must be in writing.
Personnel Qualifications
Each person must have the education, training, and experience to be enabled to perform the assigned functions related to their employment, including cGMPs. Each supervisor must also have the education, training, and experience to perform assigned functions to provide assurance that the drug product has the safety, identity, strength, quality, and purity represented. Also, there must be sufficient qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
Personnel Responsibilities
Personnel must wear clean clothing suitable for the duties they perform. Protective apparel, including head, face, hand, and arm coverings, shall be worn to protect drug products from contamination. Personnel must maintain good sanitation and health habits. Only authorized personnel shall enter the areas designated as limited-access areas. Any person with apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined to not jeopardize the safety or quality of drug products. Any health conditions that may have an adverse effect on drug products must be reported to supervisory personnel.
Consultants
Consultants must have sufficient education, training, and experience, or any combination, to advise on the subject for which they are retained. Records stating the name, address, and qualifications of any consultants, and the type of service they provide must be maintained.
Next week, we will summarize the section on "Buildings and Facilities."
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy
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Hospital Cancer Researchers Reformulating Cancer Drugs into Liquids!
Researchers at Children's Mercy Hospital and the University of Kansas (KU) Medical Center are reformulating drugs into liquids that are easy to swallow and taste good.
"It's sweet, nondescript, not quite cherry-flavor," Kathleen Neville, a cancer drug researcher at Children's Mercy, said of a liquid version of a mainstay cancer drug that may soon be tried on patients.
Neville, along with Amy (mother) and Trevor (patient) Jolley, were part of a presentation Wednesday at Children's Mercy to showcase cancer research collaborations between the hospital and other research centers.
KU is trying to gain designation as a National Cancer Institute cancer center which requires an extensive research portfolio. Neville is working with researchers at the KU Cancer Center's drug discovery program to develop a liquid version of 6-mercaptopurine (6-MP). The drug has been around as a tablet for about 50 years. Pharmacists can crush and mix 6-MP into a liquid for large medical centers, such as Children's Mercy, that have access to a compounding pharmacy to customize drugs. But this service isn't available at every hospital, and mixing 6-MP this way "is not an exact science," Neville said. She is already planning to work with KU on "pediatric-friendly" reformulations of other cancer drugs.
http://www.kansascity.com/2013/02/06/4052660/two-kc-hospitals-take-on-pills.html
Only 4 Out of 37 Massachusetts Compounding Pharmacies Passed Unannounced Health Inspections
Unannounced state inspections at 37 specialty pharmacies in Massachusetts show that only four have been fully complying with industry safety standards, health officials announced Tuesday. Serious violations of state pharmacy regulations were found in 11 compounders, prompting the state to temporarily shut down all or part of their operations, while 21 others were cited for more minor violations.
"I am sure the same things would be found in other states, not just Massachusetts," said Michael Cohen, president of the Institute for Safe Medication Practices, a Pennsylvania-based nonprofit. Yet, unlike Massachusetts, many states do not require compounding pharmacies to follow nationally accepted safety guidelines, Cohen added.
Madeleine Biondolillo, director of the Health Department's Bureau of Health Care Safety and Quality, said there is no evidence that patients have been harmed by the pharmacies' products. She stated that the range of problems discovered were not as serious as those uncovered at NECC. Biondolillo said many of the latest problems relate to flaws in the design or operation of the cleanrooms. In the past, they had inspected pharmacies only when they open, expand, or receive a complaint. "We are now going at it proactively," Biondolillo said.
http://www.boston.com/whitecoatnotes/2013/02/05/just-massachusetts-compounding-pharmacies-passed-surprise-health-inspections/zFT7FKklNPfj6EdW4tYu1L/story.html
Drug Makers Taking New Steps to Lower Their Taxes by Shifting Abroad
Drug makers, some paying effective tax rates of 20% or higher, are seeking even lower rates by shifting revenue overseas where it can be taxed at a lower rate than in the U.S., experts say. These decreases in tax rates could mean hundreds of millions of dollars in extra profit for the companies, without having to sell more drugs or launch new ones. One company said the lower tax rate could raise profits by $200 million in 2013.
http://online.wsj.com/article/SB10001424127887324906004578288353281028598.html?_nocache=1360270955510&user=welcome&mg=id-wsj
Cut and Paste in Electronic Health Records Problematic
Copying and pasting information is common within Electronic Health Records (EHRs). However, the practice sometimes can lead to confusion and endanger patient care. This practice of carelessly copying and pasting previous information, often dubbed "sloppy and paste," is widespread across medicine and can lead to mix-ups that sometimes harm patients, research shows.
February's Critical Care Medicine contains an article that copying and pasting is the rule in EHRs rather than the exception. A similar study in the January-February 2010 issue of Journal of the American Medical Informatics Assn found a copy-and-paste rate of 78% in sign-out notes generated by internal medicine residents. The rate of copied text in progress notes was 54%, the study reported.
"It's an epidemic," he said. "And it's among people who should know better. The common characteristic is that it's a tremendous time-saver to take this shortcut for people too busy to do it the right way. The right way is to make sure everything in that note you're about to sign reflects what's going on today."
http://www.ama-assn.org/amednews/2013/02/04/prl20204.htm
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