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Editorial: Current Good Manufacturing Practice (cGMP) Regulations, Part 3

In continuing our discussions on Current Good Manufacturing Practices (cGMPs), we will cover about two general sections per week. This week, let's look at Section A. General Provisions.

Title 21 Food and Drugs
Chapter I-Food and Drug Administration, Department of Health and Human Services
Subchapter C-Drugs: General
Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals

A. General Provisions
Scope- Contains an explanation that these GMPs are the "minimum" for the preparation of drug products for humans or animals.

Definitions-Refers to Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General. Specifically, Sec. 210.3 presents the definitions for Part 211 and includes definitions of (1) Act, (2) Batch, (3) Component, (4) Drug product, (5) Fiber, (6) Nonfiber releasing filter, (7) Active ingredient, (8) Inactive ingredient, (9) In-process material, (10) Lot, (11) Lot number, (12) Manufacture, processing, packing, or holding of a drug product, (13) Medicated feed, (14) Medicated premix, (15) Quality control unit, (16) Strength, (17) Theoretical yield, (18) Actual yield, (19) Percentage of theoretical yield, (20) Acceptance criteria, (21) Representative sample, and (22) Gang-printed labeling.

For comparison, let's look at the definitions of drug product, drug, and new drug.

The definition of "(4) drug product" means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. It also includes finished dosage forms without an active ingredient that is used as a placebo.

For comparison, a "drug" is defined by the U.S. Food and Drug Administration (FDA) as:

• A substance recognized by an official pharmacopoeia or formulary.
• A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
• A substance (other than food) intended to affect the structure or any function of the body.
• A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
• Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)

The general FDA definition of a "new drug" is "any that is not recognized as being safe and effective in the conditions recommended for its use among experts who are qualified by scientific training and experience."

The definition of "(16) strength," includes (a) the concentration of the drug substance (wt/wt, wt/vol, or unit dose/volume basis), and (b) the potency, or the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard). It is of interest to note that the term "strength" is more encompassing and generally more correct to use than "potency."

Next week, we will look at the organization and personnel sections to review their requirements.


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

The Drug-Dose Gender Gap
Many sleep aids are designed to last up to eight hours. When evaluating a new short-acting sleep aid for individuals to take when waking up in the middle of the night, the FDA scientists wanted to know how much of the drug would still demonstrate a blood level in the morning.

What they found was a gender gap: men metabolized the drug, zolpidem (Intermezzo), faster than women; therefore, the FDA approved a 3.5-milligram dose for men, and a 1.75-milligram dose for women. Zolpidem is used in other sleeping aids, including Ambien, and, recently, the FDA reduced doses of Ambien for women by half.

Sleep aids are not the only medications that may have unexpected, even dangerous, effects in women; this phenomenon also occurs in many drugs, from aspirin to anesthetics. Many believe that as a result, women may experience a disproportionate share of adverse, often more severe, side effects.
http://well.blogs.nytimes.com/2013/01/28/the-drug-dose-gender-gap/?partner=rss&emc=rss

Assets of Owners of Meningitis-linked Pharmacy Frozen
A bankruptcy judge has just frozen the assets of the owners of the pharmacy linked to a deadly U.S. meningitis outbreak. The orders signed by U.S. Bankruptcy Judge temporarily restrict the owners of New England Compounding Center (NECC) from selling their luxury homes or spending up to $21 million they received last year in salary and shareholder distributions.

Recent disclosures show how privately-held NECC's largest shareholder Carla Conigliaro, for example, received nearly $9 million in 2012, Barry Cadden, NECC's chief pharmacist, received about $3.2 million in 2012, his wife Lisa Cadden received about $2.8 million, and Greg Conigliaro, a recycling entrepreneur, who is Lisa Cadden's brother and Carla Conigliaro's brother-in-law, received about $1.6 million.
http://www.reuters.com/article/2013/01/28/us-usa-health-meningitis-necc-idUSBRE90R0XI20130128

India Pharma Companies Lead Race in U.S. for Drug Master Files Filings
The generic market for off-patent drugs in the U.S. intensifies, and Indian companies remain at the top in filing drug master files (DMFs) with the FDA. Filing a DMF is necessary to sell ingredients for third-party sales. Drugs worth $35 billion went off-patent in the U.S. in 2012, while the market size of drugs which will see patent expiry in 2013 will be about $17 billion. Indian companies filed about 50% of the DMFs in the past four years. In the last quarter, DMFs have been filed for rosuvastatin, fingolimod, febuxostat, lacosamide, lacosamide, rufinamide, fesoterodine, and febuxostat by various companies.
http://www.business-standard.com/india/news/indian-majors-lead-race-for-us-drug-ingredient-market/500437/

Herbal Medicines
4th Edition
Pharmaceutical Press
January 2013; Hardback; 928 Pages; $160

An outstanding, easy-to-use, and readable compilation of scientifically rigorous, impartial information on 180 of the most commonly used herbal medicinal products. The individual monographs are extensively referenced, detailing photochemical, pharmacological, and clinical aspects of each herb (use, dose, adverse effects, interactions, etc.). It is in full color and contains chemical structures and photographs where available. Not only is it an excellent reference resource, it is good general reading and highly recommended.

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