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Editorial: Current Good Manufacturing Practice (cGMP) Regulations, Part 11

This week, we will summarize Subpart I: Laboratory Controls. The following are the subpart sections and a brief description of their content.

Subpart I-Laboratory Controls

Sec. 211.160 General Requirements
The appropriate organizational unit is responsible for establishing specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required. These requirements will be followed and documented at the time of performance. Any deviation must be justified and recorded.

The specifications require written specifications for the acceptance of each lot of components, drug product containers, closures, and labeling used in the manufacturing, processing, packing, or holding of drug products.

Instruments, apparatus, gauges, and recording devices must be recorded at suitable intervals in accordance with established written procedures containing specific directions, schedules, limits for accuracy, and precision for remedial action in the event accuracy with precision limits are not met. Any item not meeting the required established specifications shall not be used.

Sec. 211.165 Testing and Release for Distribution
Each batch of product requires appropriate laboratory determination of satisfactory conformance to final specifications for the drug product. The accuracy, sensitivity, specificity, and reproducibility of test methods shall be established and documented. Drug products failing to meet established standards or specifications or other quality-control criteria shall be rejected. Reprocessing may be performed.

Sec. 211.166 Stability Testing
A complete written testing program is required for assessing the stability characteristics of drug products. Testing must be done in the same container-closure system as that in which the drug product is marketed.

Sec. 211.167 Special Testing Requirements
Appropriate testing for sterility and/or pyrogen-free drug products must be developed, written down, and followed.

Sec. 211.170 Reserve Samples
There are specific requirements for samples that must be retained for future testing. The reserve samples generally are twice the quantity required to perform all the required tests, except for sterility and pyrogens. There are specific requirements for retention of different products with different expiration dates.

Sec. 211.173 Laboratory Animals
Specific standard operating procedures must be in place for properly maintaining animals in such a way that ensures their suitability for their intended use.

Sec. 211.176 Penicillin Contamination
Potential contamination of a non-penicillin drug product with penicillin is addressed in this section.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy

OEI Memo: High-risk Compounded Sterile Preparations (CSPs) and Outsourcing
In 2012, 92% of hospitals used CSPs. Almost all hospitals (92%) used sterile-to-sterile CSPs, and only 25% of hospitals used higher risk nonsterile-to-sterile products. Of the hospitals that used nonsterile-to-sterile CSPs, 85% outsourced at least some of these products (i.e., purchased them from outside pharmacies). Factors related to ensuring an adequate supply of CSPs were very important to hospitals when determining whether to outsource CSPs. Also, hospitals took limited steps to ensure the quality of outsourced CSPs but had few problems with the quality of products from outside pharmacies. Finally 56% of hospitals made changes or planned to make changes to CSP sourcing practices in response to the Fall 2012 meningitis outbreak.
http://oig.hhs.gov/oei/reports/oei-01-13-00150.pdf

Pfizer Voluntarily Recalls Levoxyl
King Pharmaceuticals, a wholly owned subsidiary of Pfizer, has initiated a voluntary recall of Levoxyl (levothyroxine sodium). The recall was initiated after learning of complaints from pharmacists and patients of an uncharacteristic odor coming from Levoxyl bottles. It was determined that the odor was caused by an oxygen-absorbing canister added to 100- and 1000-tablet pharmacy bottles to enhance the stability of the product. The company stated that the odor is not likely to cause any adverse health consequences.
http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=810051&topic=410

Medication Study Shows Antibiotic Overuse
U.S. physicians are prescribing enough antibiotics to provide them to 4 out of 5 Americans every year. Overuse is one reason for the development of resistance. There is no consensus on an appropriate level of antibiotic prescribing, but some experts said the new study's results are disturbing and that rates are probably excessive even in the states with the lowest antibiotic prescription levels.
http://hosted.ap.org/dynamic/stories/U/US_MED_ANTIBIOTIC_PRESCRIPTIONS?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2013-04-10-18-13-14

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