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Editorial: Current Good Manufacturing Practice (cGMP) Regulations, Part 8

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

Sec. 211.100 Written Procedures; Deviations
There shall be written procedures for production and process control. These procedures must be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality-control unit. Any deviation from the written procedures must be recorded and justified.

Sec. 211.101 Charge-in of Components
All components must be weighed, measured, or subdivided as appropriate. Complete labeling is detailed which must be followed for the new container into which it is placed.

Sec. 211.103 Calculation of Yield
At each appropriate phase of production, the actual yields and percentages of theoretical yield shall be determined.

Sec. 211.105 Equipment Identification
All storage containers, processing lines, and major equipment used in the production of a batch of a drug product shall be properly identified at all times to indicate contents, and, if needed, the phase of processing of the batch.

Sec. 211.110 Sampling and Testing of In-process Materials and Drug Products
Written procedures shall be established and followed that describe the controls, and tests, to be conducted on appropriate samples of in-process materials in each batch.

Sec. 211.111 Time Limitations on Production
As appropriate, there shall be time limitations established for each phase of production.

Sec. 211.113 Control of Microbiological Contamination
Appropriate procedures must be in place regarding microbiological contamination of both nonsterile and sterile production.

Sec. 211.115 Reprocessing
There must be written procedures established and followed describing a system for reprocessing non-conforming batches of product.


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

Pet Care Is Targeted Prize for Medicine Makers
Prompted by demand and technological developments, pet medicines are feeding on human research and human medicines that are being used on animals; thus blurring the lines between treatment methods for different species. The pet market was valued at �19.43 billion in 2012 and is growing steadily as pet ownership becomes more widespread. Canine healthcare products dominate the market, accounting for $9.7 billion in 2010, nearly half the total pet healthcare market for that year. Cat products, at $4.8 billion, were the second largest sector.
http://online.wsj.com/article/SB10001424127887323415304578368432503265260.html?mod=WSJ_hp_Europe_EditorsPicks&cb=logged0.2070211935714667

Sanofi Manufacturing "Delays" Cause Shortage of TB Drug
Manufacturing "delays" are causing a shortage of Rifamate capsules containing 300 mg rifampin and 150 mg isoniazid. The company estimates the next delivery of the drugs will be in June and that they will be available by July. Per the recently signed FDA Safety and Innovation Act (FDASIA) of 2012, companies involved with shortages must provide a reason for the shortage, but Sanofi has listed its reason as "other" without any further clarification.
http://www.outsourcing-pharma.com/Contract-Manufacturing/Sanofi-Manufacturing-Delays-Cause-Shortage-of-TB-Drug

Two Compounding Pharmacies Initiate Recalls
A compounding pharmacy in Augusta, Georgia, is voluntarily recalling 79 lots of bevacizumab-filled syringes (Avastin, Genentech) intended for retinal injections because of the risk for eye infection. The action is part of the continuing FDA crackdown on such pharmacies after the NECC debacle.

Also, the FDA has announced that a compounding pharmacy in New Jersey was voluntarily recalling all of its products after a Connecticut hospital (Yale-New Haven Hospital) reported that 5 bags of magnesium sulfate from the pharmacy were contaminated with mold.
http://www.medscape.com/viewarticle/781039

http://www.norwichbulletin.com/newsnow/x1959358804/N-J-pharmacy-recalls-IV-bags-used-in-Conn-due-to-mold#axzz2OD1BFRRr

FDA Shakes Down Hospira Facility
The FDA has completed a 3-week inspection of Hospira's Rocky Mount, North Carolina, facility, which has been under the watchdog agency's eye since an April 2010 warning letter. The Agency said 5 agency inspectors reviewed the facility for 3 weeks and issued a Form 483 warning, flagging 20 problems at the plant.
http://www.massdevice.com/news/fda-shakes-down-hospira-facility-3-week-inspection

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding

�that the Student Pharmacist Compounding Competition (SPCC) sponsored by Medisca and the University of Florida College of Pharmacy is going on this weekend?

If your college has participants in the SPCC, let them know that you are proud of their compounding accomplishments and support them!

Train approaching,
Whistle squealing!
Pause! Avoid that
Rundown feeling!
      Burma Shave

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

Pharmacy Innovations, Erie, Pennsylvania. Emily Swanson, CPhT, emilys@pharmacyinnovations.net: Re-accreditation for Sterile and Nonsterile Compounding

Bird's Hill Pharmacy, Needham, Massachusetts. Andrew Stein, PharmD, birdshillpharmacy@verizon.net: Re-accreditation for Nonsterile Compounding

Snyder-Mark Drugs Roselle, Roselle, Illinois. Mark Mandel, PharmD, wemakdrugs@aol.com. Re-accreditation for Sterile and Nonsterile Compounding

Custom Rx LLC, Kuna, Idaho. Travis Walthall, RPh, travcrash@hotmail.com. Initial Accreditation for Nonsterile Compounding

CarePro Compounding, Cedar Rapids, Iowa. Lucinda Harms, RPh, lharms@careprohs.com. Initial Accreditation for Sterile and Nonsterile Compounding

Professional Arts Pharmacy, Lafayette, Louisiana. Kevin LaGrange, PharmD, kevin@professionalarts.com. Re-accreditation for Sterile and Nonsterile Compounding

Stanley Apothecary, Charlotte, North Carolina. Douglas Yoch, PharmD, doug@stanleyrx.com. Re-accreditation for Sterile and Nonsterile Compounding

Intrathecal Compounding Specialist, Scott, Louisiana. Stuart Burgess, RPh, stuart@icspharmacy.com. Re-accreditation for Sterile Compounding