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Editorial: Current Good Manufacturing Practice (cGMP) Regulations, Part 2

In continuing our discussions on Current Good Manufacturing Practice (cGMPs), we will now look at the subtopics contained in the cGMPs. Over the next few weeks, we will compare these with the Good Compounding Practices (GCPs) for compounding. As you look through the detailed list, it becomes apparent that many of these are also a part of GCPs.

1. General Provisions
   Scope
   Definitions
   
   
2. Organization and Personnel
   Responsibilities of quality control unit
   Personnel qualifications
   Personnel responsibilities
   Consultants
   
   
3. Buildings and Facilities
   Design and construction features
   Lighting
   Ventilation, air filtration, air heating and cooling
   Plumbing
   Sewage and refuse
   Washing and toilet facilities
   Sanitation
   Maintenance
   
   
4. Equipment
   Equipment design, size, and location
   Equipment construction
   Equipment cleaning and maintenance
   Automatic, mechanical, and electronic equipment
   Filters
   
   
5. Control of Components and Drug Product Containers and Closures
   General requirements
   Receipt and storage of untested components, drug product containers,
     and closures
   Testing and approval or rejection of components, drug product containers,
     and closures
   Use of approved components, drug product containers, and closures
   Retesting of approved components, drug product containers, and closures
   Rejected components, drug product containers, and closures
   Drug product containers and closures
   
   
6. Production and Process Controls
   Written procedures; deviations
   Charge-in of components
   Calculation of yield
   Equipment identification
   Sampling and testing of in-process materials and drug products
   Time limitations on production
   Control of microbiological contamination
   Reprocessing
   
   
7. Packaging and Labeling Control
   Materials examination and usage criteria
   Labeling issuance
   Packaging and labeling operations
   Tamper-resistant packaging requirements for OTC human drug products
   Drug product inspection
   Expiration dating
   
   
8. Holding and Distribution
   Warehousing procedures
   Distribution procedures
   
   
9. Laboratory Controls
   General requirements
   Testing and release for distribution
   Stability testing
   Special testing requirements
   Reserve samples
   Laboratory animals
   Penicillin contamination
   
   
10. Records and Reports
    General requirements
    Equipment cleaning and use log
    Component, drug product container, closure, and labeling records
    Master production and control records
    Batch production and control records
    Production record review
    Laboratory records
    Distribution records
    Complaint files
    
    
11. Returned and Salvaged Drug Products
    Returned drug products
    Drug product salvaging

Mercury Treatment Activities Not Affecting Thimerosal-containing Vaccines
A global treaty will soon be presented to countries for their ratification as part of a worldwide effort to control and reduce ways in which mercury is used, released, or emitted. Included in the treaty are items about certain mercury-added products (e.g., batteries, lamps, switches, skin-lightening cosmetics, pesticides, thermometers) that may not be manufactured, imported or exported any later than 2020. Also, mercury-added dental amalgams are also to be phased out.

Certain mercury-added products are to be exempted from the ban, including those used for military and civil protection, products with no mercury-free alternative, products used in religious or traditional practices, and vaccines containing thimerosal, an ethylmercury preservative.
http://www.washingtontimes.com/news/2013/jan/19/treaty-on-mercury-would-not-affect-vaccines-with-t/

Pharma's Declining Reputation: What Can Be Done
There are many unflattering articles about the pharmaceutical industry. Dr. Oz, for example with over 4-million daily viewers, devoted the bulk of a show to "Four Secrets Drug Companies Don't Want You To Know." The industry actually had a banner year in 2012 with the FDA approving 39 new medicines; however, many talk show hosts and others minimize this achievement by saying that pharma is spending too much on too little output. Also, prominent physicians have publicized a letter sent to the White House urging enactment of a law to force public disclosure of pharma company payments to doctors. Consequently, the industry suffers a "black eye."

Why the negative view from a patient's perspective? Many advocate groups list a number of areas where pharma was rated as having a "poor" record including (1) a lack of fair pricing policies leading to unseemly profits (50%), (2) a lack of transparency in all corporate activities (48%), (3) management of adverse event news (37%), and (4) acting with integrity (32%).
http://www.forbes.com/sites/johnlamattina/2013/01/18/pharmas-reputation-continues-to-suffer-what-can-be-done-to-fix-it/?

Costco Launches Pharmacy-benefit Manager Program
Costco has quietly started a pharmacy-benefit program for small and midsize businesses, putting the retailer into the market for handling drug plans currently led by Express Scripts and CVS Caremark. Costco Health Solutions, the pharmacy-benefit manager (PBM) that will fill prescriptions for business customers, expects its new program to increase foot traffic in stores. The program involves prescription medicines through its in-warehouse pharmacies or a network of 64,000 independent pharmacies that have agreed to pre-negotiated prices.
http://online.wsj.com/article/SB10001424127887323968304578247982570309620.html?_nocache=1358623173947&user=welcome&mg=id-wsj

Navajo Nation Considering Becoming the 51st Medicaid State
The Navajo Nation wants to become the 51st Medicaid state; an option allowed by the Affordable Care Act. The Navajo Nation stretches across three states—Arizona, New Mexico, and Utah, which means their medical services, funds, and policies become fragmented. Consequently, the tribe would like to be seen as a separate state when it comes to Medicaid reimbursements from the federal government. The tribe is finalizing its study and plans on going to Congress for approval in March.
http://www.knau.org/post/navajo-nation-wants-be-51st-medicaid-state
http://www.heraldnews.com/news/x2105872669/Local-health-officials-say-prescription-drug-shortage-affecting-area

Blindness More Likely in Those Taking Aspirin Regularly
People taking aspirin regularly, such as those with heart problems, are more likely to develop a form of blindness. A JAMA Internal Medicine-published study of 2,389 people, showed aspirin takers had twice the risk of "wet" age-related macular degeneration. However, they said there was not yet enough evidence to change aspirin use.
http://www.bbc.co.uk/news/health-21120025

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PCAB is proud to announce the accreditation of the following pharmacy:

Sierra Health Mart Pharmacy, Downtown Reno, NV; David Vasenden, RPh, david@donspharmacy.com; Reaccreditation for Nonsterile Compounding